Tympanoplasty is a surgical intervention aimed at the reconstruction of the tympanic membrane (eardrum) and the ossicles in cases of chronic otitis media (COM) and tympanic membrane perforations. The procedure, specifically Type 1 tympanoplasty, focuses solely on the repair of the tympanic membrane without ossicular reconstruction. Successful tympanoplasty is essential for restoring hearing, preventing recurrent infections, and improving the quality of life for patients. Various graft materials have been utilized in this procedure, with temporalis fascia and tragal cartilage being among the most prominent.(1,2)

Chronic otitis media often leads to persistent tympanic membrane perforations, which can result in significant hearing loss and susceptibility to recurrent infections. The choice of graft material for tympanoplasty is paramount in determining the success of the surgery. Temporalis fascia has been the gold standard for many years due to its availability, ease of harvest, and favourable handling properties. However, recent studies have highlighted the potential benefits of using cartilage, particularly sliced tragal cartilage, as an alternative graft material.(3)

Temporalis fascia, derived from the fibrous connective tissue over the temporal muscle, is known for its excellent integration and low rejection rates. It is thin and pliable, making it easy to manipulate and position during surgery. Nevertheless, its tendency to atrophy and retraction, particularly in large or subtotal perforations, has led surgeons to explore more robust alternatives.(4,5,6)

Tragal cartilage, harvested from the cartilaginous portion of the external ear, presents a promising alternative. Its inherent rigidity and resistance to retraction make it particularly suitable for larger perforations and those involving multiple quadrants. The use of cartilage in tympanoplasty, although technically more challenging, has been associated with higher graft success rates and better long-term outcomes in terms of graft stability and hearing improvement.(7)

The comparative evaluation of sliced tragal cartilage and temporalis fascia in the context of Type 1 tympanoplasty, particularly for large or subtotal perforations, is crucial for several reasons. First, large perforations pose a unique challenge due to the increased risk of graft failure and the need for more robust support to ensure effective closure and healing. Second, understanding the specific advantages and limitations of each graft material can inform surgical decisions and potentially improve patient outcomes.(8)

The historical development of tympanoplasty techniques and graft materials reflects a journey of continuous innovation and refinement. From the early experimental efforts to the sophisticated procedures and materials used today, each advancement has contributed to improved surgical outcomes and patient quality of life. The evolution of tympanoplasty has been marked by the pioneering work of otologists who have sought to restore hearing and protect the middle ear through innovative techniques and materials. As research continues and new technologies emerge, the field of tympanoplasty will undoubtedly continue to advance, offering even better solutions for patients with tympanic membrane perforations.(9)

Previous studies have provided mixed results regarding the superiority of one graft material over the other. While some research indicates better success rates with cartilage grafts in large perforations, other studies suggest comparable outcomes between cartilage and fascia. Therefore, a comprehensive evaluation in a tertiary care setting, where complex cases are more prevalent, is essential to provide clarity on this issue.(10,11)

Our study aims to evaluate and compare the outcomes of sliced tragal cartilage versus temporalis fascia grafts in patients undergoing Type 1 tympanoplasty for large or subtotal perforations. (4) The study was conducted in a tertiary care hospital, providing a clinical environment for the evaluation of these surgical techniques.

AIMS AND OBJECTIVES

Aim

To evaluate and compare the surgical outcomes of sliced tragal cartilage grafts versus temporalis fascia grafts in patients with large or subtotal tympanic membrane perforations (involving two or more quadrants) undergoing Type 1 tympanoplasty in a tertiary care hospital setting.

Objectives

1. Graft Integration Success Rate: To compare the rate of successful graft integration (graft uptake rate) between patients receiving sliced tragal cartilage grafts and those receiving temporalis fascia grafts.
2. Audiological Outcomes: To assess and compare the postoperative hearing improvement in terms of air-bone gap closure and overall hearing levels in patients receiving either sliced tragal cartilage or temporalis fascia grafts.
3. Postoperative Complications: To document and compare the incidence of postoperative complications, including infection, graft rejection, and re-perforation, between the two groups of patients.

Study Type: This was a prospective, interventional, hospital-based study.

Study Design: A randomized control trial was conducted.

Study Place: Tertiary care Hospital.

Study Population:

The study included patients attending the ENT department who were scheduled for Type 1 Tympanoplasty with large or subtotal perforations.

Inclusion Criteria:

Patients aged 15-60 years of either sex, with a Middle Ear Risk Index (MERI) score less than 3, and chronic otitis media mucosal inactive.

MERI Index :⁽⁴⁵⁾

A value is assigned for each risk factor, and then the values are added to determine the MERI (Middle Ear Risk Index).

M = malleus, I = incus, S = stapes

Exclusion Criteria:

• Patients younger than 15 years or older than 60 years,
• Those with an active discharging ear,
• Patients undergoing revision tympanoplasty,
• And individuals who did not consent to participate in the research were

Sample size estimation

The study included 66 patients, determined based on inclusion and exclusion criteria.

METHOD OF COLLECTION OF DATA:

1. Written informed consent will be taken
2. Pre-Operative assessment of patients which includes:
3. Detailed history of the patient
4. Detailed N.T Examination of patient including examination under Microscope and Audiological assessment
5. Classifying perforation based on MIDDLE EAR RISK INDEX (MERI)

Investigations of the investigations

• Otological Examination and Tuning Fork Tests
• Audiological Assessment
• Examination under Microscope
• Bleeding Time and Clotting Time
• Blood Pressure
• Electrocardiography
• Routine Blood Investigation

1. Complete Blood Count
2. HIV
3. HBsAg
4. Random Blood Sugar

1. Pre-operative preparation of patient.

• Surgery of Type 1 Tympanoplasty using Sliced Tragal Cartilage in Group A and Temporalis Fascia Graft in group B.

METHOD:

A sample of 66 subjects of mucosal inactive type of chronic otitis media will be included in this study after obtaining their informed written consent.

A detailed examination of ear done, and pure tone audiometry will be done preoperatively.

The air conduction hearing loss will be assessed by taking the average of hearing loss in decibel at 500Hz, 1000Hz and 2000Hz.

They will be randomly divided into two groups – cartilage and Fascia groups with 33 in each group who will underwent either with Sliced Cartilage or Temporalis Fascia alternatively. The data collected from these tests and investigations will be subjected to appropriate statistical tests to arrive at suitable conclusions.

Type 1 Tympanoplasty for both sliced tragal cartilage and Temporalis Fascia graft- steps:

1. For tragal cartilage harvest –Skin incision is made 2-3 mm medial to tragal Iris scissors are used to dissect the cartilage in Subperichondrial Plane, leaving the lateral 3mm of the cartilage to preserve the shape of tragus.
2. For slicing tragal cartilage - using cartilage slicer to optimal thickness of 5 mm.
3. For Temporalis Fascia graft harvest: Post aural skin flap is developed and elevated by making incisions at about 6 O clock and 12 O clock positions starting medially about 5mm lateral to the fibrous annulus and carried upto bony Post auricular William Wilde incision is made at the sulcus and Temporalis Fascia is harvested and dry preserved.
4. The margins of the perforation will be
5. Tympanomeatal flap will be
6. Middle Ear will be inspected for
7. Sliced cartilage or Temporalis Fascia graft will be
8. Tympanomeatal flap will be
9. Sutures External Auditory Canal will be packed with gel foam. Haemostasis will be achieved. Dressing will be done

Postoperative care:

Patients will be advised to take water precautions and avoid vigorous nose blowing. Post aural sutures in case of Temporalis Fascia graft and aural pack in the ear canal will be removed after 1 week and antibiotic-steroid ear drops will be started then. Patients will be kept on oral antibiotics for 1 week. The gel foam will be allowed to resolve gradually on its own. The operated patients will be examined at 1 week, 3 weeks and then 3 months and 6 months post- operatively. A PTA will be repeated at 3 months and 6 months once a viable graft is visible, and patient is asymptomatic.

Ethical Clearance:

Approval was obtained from the Institutional Ethics Committee (IEC) before commencing the   study in November 2022.

Study Procedure:

Written informed consent was obtained from all participants. Pre-operative assessments included detailed patient history, comprehensive ENT examination, examination under a microscope, and audiological assessment. Perforations were classified based on the Middle Ear Risk Index (MERI), which considers factors such as otorrhea, perforation, cholesteatoma, ossicular status, middle ear granulation, previous surgery, and smoking. Patients were then randomly assigned to undergo tympanoplasty using either sliced tragal cartilage or temporalis fascia grafts. Study Outcome

Variables:

The primary outcomes measured were the graft uptake rate and hearing improvement, assessed post-operatively at regular intervals. The primary outcome variables were graft uptake rate and hearing improvement. Graft uptake was assessed by examining the tympanic membrane post-operatively for successful integration of the graft. Hearing improvement was measured through audiological assessments, including pure tone audiometry, conducted pre-operatively and at follow-up intervals to evaluate changes in hearing thresholds. Secondary outcomes included the incidence of post-operative complications, such as infection or graft displacement, and patient satisfaction with the surgical outcomes. Statistical comparisons were made between the two groups (sliced tragal cartilage and temporalis fascia grafts) to determine the efficacy and safety of each grafting technique.

Statistical Analysis:

• Data analysis was performed using SPSS software version 23 and MS Excel 2017. Continuous variables were expressed as mean ± standard deviation, and non-normally distributed variables were presented as median (interquartile range).
• Qualitative variables were represented as percentages and
• Associations between qualitative variables were analyzed using the chi-square test or Fisher's exact test, as appropriate.
• The significance of differences between means was assessed using an independent sample t-test.
• A two-tailed P < 05 was considered statistically significant.

In a study comparing cartilage (Group A) and fascia (Group B) usage across different age groups, the total number of participants was 70, with 35 in each group. The distribution among age groups was as follows: 15-20 years (9 participants), 21-30 years (17 participants), 31-40 years (18 participants), 41-50 years (15 participants), and 51-60 years (11 participants). Both groups had an equal number of participants across all age ranges.

In a study of 70 patients, divided equally between Group A (cartilage) and Group B (fascia), the mean age was 35.9 years with a standard deviation of 12.7. Group A had a mean age of 35.6 ± 12.4 years, while Group B had a mean age of 36.2 ± 13.1 years. Gender distribution was similar across both groups, with 37 males and 33 females in total.

Table 1: Patient Demographics

In a study of 70 patients, the MERI scores for Group A (cartilage) and Group B (fascia) showed that 38 patients scored between 0-1, with 20 from Group A and 18 from Group B. Additionally, 32 patients scored between 2-3, with 15 from Group A and 17 from Group B. The overall mean MERI score was 1.7 ± 0.7, with Group A having a mean of 1.6 ± 0.7 and Group B a mean of 1.8± 0.6.

Table 2: MERI Score Distribution

In a study of 70 patients, the graft uptake rate was 88.6%, with 62 successful cases and 8 failures. Group A (cartilage) had a 91.4% success rate (32 successful, 3 failed), while Group B (fascia) had an 85.7% success rate (30 successful, 5 failed).

In a study of 70 patients, the mean audiological improvement was 10.1 dB with a standard deviation of 4.5. Group A (cartilage) showed an improvement of 10.5 ± 4.2 dB, while Group B (fascia) showed an improvement of 9.8 ± 4.7 dB at 3 months interval. In a study of 70 patients, the mean audiological improvement was 15.0 dB with a standard deviation of 5.2. Group A (cartilage) showed an improvement of 15.3 ± 5.1 dB, while Group B (fascia) showed an improvement of 14.6 ± 5.4 dB at 6 months interval.

In a study of 70 patients, follow-up rates were consistent across different periods. At 1 week and 3 weeks, 91.4% of Group A (cartilage) and 85.7% of Group B (fascia) were followed up, resulting in an overall follow-up rate of 88.6%. At 3 months and 6 months, the follow-up rates were 88.6% for Group A and 82.9% for Group B, with an overall rate of 85.7% at both intervals.

Table 4: Comparison of Graft Uptake Rates

In a study of 70 patients, complications included 3 cases of infection (1 in Group A and 2 in Group B), 5 cases of residual perforation (2 in Group A and 3 in Group B), and 1 other complication reported in Group B.

Table 5: Post-operative Complications

In a study involving 70 patients, the occurrence of dry ear was assessed with 58 patients reporting experiencing it (30 in Group A, 28 in Group B), while 12 patients did not (5 in Group A, 7 in Group B). This suggests a higher prevalence of dry ear in both groups, particularly slightly more in Group A compared to Group B. In a study of 70 patients, the incidence of dry ear was evaluated, revealing 56 cases in total, with 29 patients experiencing it in Group A (cartilage) and 27 in Group B (fascia). Conversely, 14 patients reported no occurrence of dry ear, with 6 in Group A and 8 in Group B. This indicates a similar incidence rate of dry ear between the two groups, suggesting comparable outcomes related to this complication.

In a study involving 70 patients, perforation rates were examined with a total of 5 cases reported. Group A (cartilage) had 2 cases of residual perforation, while Group B (fascia) had 3 cases. Conversely, 65 patients did not experience perforation, with 33 in Group A and 32 in Group B. This indicates a slightly higher incidence of residual perforation in Group B compared to Group A, but overall, the majority of patients in both groups did not develop perforation.

Table 6: Comparison of Perforation Rates at 6 Months

In a study involving 70 patients, the perforation rates were evaluated, with a total of 7 cases of residual perforation reported. Specifically, Group A (cartilage) had 3 cases, while Group B (fascia) had 4 cases. On the other hand, 63 patients did not experience any perforation, with 32 in Group A and 31 in Group B. This indicates a slightly higher incidence of residual perforation in Group B compared to Group A, though the majority of patients in both groups did not develop this complication.

In a study of 70 patients, satisfaction scores (dry ear, hearing improvement, graft uptake) were assessed with 49 patients reporting being very satisfied (25 in Group A and 24 in Group B), 17 patients indicating satisfaction (8 in Group A and 9 in Group B), and 4 patients expressing dissatisfaction (2 in each group). This suggests a high overall satisfaction rate in both groups, with a slightly higher number of patients in Group A reporting being very satisfied compared to Group B.

Table 7: Patient Satisfaction Scores

The analysis compared outcomes between Groups A (cartilage) and Group B (fascia) in a study involving 70 patients. Audiological improvement showed similar mean improvements of 15.3 ± 5.1 dB in Group A and 14.6 ± 5.4 dB in Group B, with a non-significant p-value of 0.67. The graft uptake rates were 88.6% for Group A and 82.9% for Group B, also not significantly different (p = 0.52). However, post-operative complications differed slightly, with 8.6% in Group A and 17.1% in Group B, yielding a p-value of 0.31, indicating no significant difference between the groups in this aspect as well.

 Table 8: Statistical Analysis Summary

Type 1 tympanoplasty is a surgical procedure aimed at repairing tympanic membrane perforations to restore hearing and prevent recurrent infections. In patients with large or subtotal perforations, involving two or more quadrants of the tympanic membrane, the choice of graft material is crucial for successful outcomes. (12)

Our study evaluates and compares the effectiveness of sliced tragal cartilage and temporalis fascia grafts in such patients. Both materials have unique properties that influence graft take rates, hearing improvement, and complication rates. Tragal cartilage is known for its robustness and resistance to retraction, while temporalis fascia is favored for its pliability and ease of handling. By comparing these grafting techniques in a tertiary care hospital setting, this research aims to provide insights into their respective advantages and limitations, thereby guiding surgeons in optimizing tympanoplasty outcomes for patients with extensive tympanic membrane perforations. (13, 14)

The study was designed as a prospective, interventional, hospital-based study involving a randomized control trial with a sample size of 66 patients. The inclusion criteria specified patients aged 15 to 60 years of either sex, with a Middle Ear Risk Index (MERI) score of less than 3, and chronic otitis media mucosal inactive. Exclusion criteria included patients under 15 or over 60 years old, those with active discharging ears, revision tympanoplasty cases, and subjects who did not consent to participate in the research.

Data were sourced from patients attending the Department of Otorhinolaryngology at Tertiary Care Hospital, over the period from November 2022 to September 2024. The study commenced in November 2022 following approval from the Institutional Ethics Committee (IEC). Over the two-year study duration, patients were systematically selected and randomized for the trial to ensure unbiased results.

The method of data collection involved obtaining written informed consent from all participants. Pre-operative assessments included a detailed history and comprehensive ENT examination, which incorporated examination under a microscope and audiological assessment. Perforations were classified based on the Middle Ear Risk Index (MERI), which considered factors such as otorrhea, perforation, cholesteatoma, ossicular status, middle ear granulation, previous surgery, and smoking history.

Distribution of Patients

In a study comparing cartilage (Group A) and fascia (Group B) usage across different age groups, the total number of participants was 70, with 35 in each group. The distribution among age groups was as follows: 15-20 years (9 participants), 21-30 years (17 participants), 31-40 years (18 participants), 41-50 years (15 participants), and 51-60 years (11 participants). Both groups had an equal number of participants across all age ranges.

Patient Demographics

In a study of 70 patients, divided equally between Groups A (cartilage) and Group B (fascia), the mean age was 35.9 years with a standard deviation of 12.7. Group A had a mean age of 35.6 ± 12.4 years, while Group B had a mean age of 36.2 ± 13.1 years. Gender distribution was similar across both groups, with 37 males and 33 females in total.

MERI Score Distribution

In a study of 70 patients, the MERI scores for Group A (cartilage) and Group B (fascia) showed that 38 patients scored between 0-1, with 20 from Group A and 18 from Group B. Additionally, 32 patients scored between 2-3, with 15 from Group A and 17 from Group B. The overall mean MERI score was 1.7 ± 0.7, with Group A having a mean of 1.6 ± 0.7 and Group B a mean of 1.8 ± 0.6.

Pre-operative Audiological Findings

In a study of 70 patients, the mean hearing loss was 42.8 dB with a standard deviation of 10.7. Group A (cartilage) had a mean hearing loss of 42.5 ± 10.2 dB, while Group B (fascia) had a mean hearing loss of 43.1 ± 11.3 dB.

Immediate Post-operative Graft Uptake

In a study of 70 patients, the graft uptake rate was 88.6%, with 62 successful cases and 8 failures. Group A (cartilage) had a 91.4% success rate (32 successful, 3 failed), while Group B (fascia) had an 85.7% success rate (30 successful, 5 failed).

Audiological Improvement at 3 Months

In a study of 70 patients, the mean audiological improvement was 10.1 dB with a standard deviation of 4.5. Group A (cartilage) showed an improvement of 10.5 ± 4.2 dB, while Group B (fascia) showed an improvement of 9.8 ± 4.7 dB.

Audiological Improvement at 6 Months

In a study of 70 patients, the mean audiological improvement was 15.0 dB with a standard deviation of 5.2. Group A (cartilage) showed an improvement of 15.3 ± 5.1 dB, while Group B (fascia) showed an improvement of 14.6 ± 5.4 dB.

Comparison of Graft Uptake Rates

In a study of 70 patients, follow-up rates were consistent across different periods. At 1 week and 3 weeks, 91.4% of Group A (cartilage) and 85.7% of Group B (fascia) were followed up, resulting in an overall follow-up rate of 88.6%. At 3 months and 6 months, the follow-up rates were 88.6% for Group A and 82.9% for Group B, with an overall rate of 85.7% at both intervals.

Post-operative Complications

In a study of 70 patients, complications included 3 cases of infection (1 in Group A and 2 in Group B), 5 cases of residual perforation (2 in Group A and 3 in Group B), and 1 other (loss of taste, paraesthesia, wound gaping) complication reported in Group B.

Long-term Outcomes (Dry Ear) at 6 Months

In a study involving 70 patients, the occurrence of dry ear was assessed with 58 patients reporting experiencing it (30 in Group A, 28 in Group B), while 12 patients did not (5 in Group A, 7 in Group B). This suggests a higher prevalence of dry ear in both groups, particularly slightly more in Group A compared to Group B.

Long-term Outcomes (Dry Ear) at 1 Year

In a study of 70 patients, the incidence of dry ear was evaluated, revealing 56 cases in total, with 29 patients experiencing it in Group A (cartilage) and 27 in Group B (fascia). Conversely, 14 patients reported no occurrence of dry ear, with 6 in Group A and 8 in Group B. This indicates a similar incidence rate of dry ear between the two groups, suggesting comparable outcomes related to this complication.

Comparison of Perforation Rates at 6 Months

In a study involving 70 patients, perforation rates were examined with a total of 5 cases reported. Group A (cartilage) had 2 cases of residual perforation, while Group B (fascia) had 3 cases. Conversely, 65 patients did not experience perforation, with 33 in Group A and 32 in Group B. This indicates a slightly higher incidence of residual perforation in Group B compared to Group A, but overall, the majority of patients in both groups did not develop perforation.

Comparison of Perforation Rates at 1 Year

In a study involving 70 patients, the perforation rates were evaluated, with a total of 7 cases of residual perforation reported. Specifically, Group A (cartilage) had 3 cases, while Group B (fascia) had 4 cases. On the other hand, 63 patients did not experience any perforation, with 32 in Group A and 31 in Group B. This indicates a slightly higher incidence of residual perforation in Group B compared to Group A, though the majority of patients in both groups did not develop this complication.

Patient Satisfaction Scores

In a study of 70 patients, satisfaction scores (dry ear, hearing improvement, graft uptake) were assessed with 49 patients reporting being very satisfied (25 in Group A and 24 in Group B), 17 patients indicating satisfaction (8 in Group A and 9 in Group B), and 4 patients expressing dissatisfaction (2 in each group). This suggests a high overall satisfaction rate in both groups, with a slightly higher number of patients in Group A reporting being very satisfied compared to Group B.

Fascia grafts across various studies, several key findings emerge. Your study, which involved 70 patients evenly split between cartilage and fascia groups, reported a mean age of 35.9 years and a gender distribution of 37 males and 33 females. It showed no significant differences in pre- operative hearing loss or post-operative complications, with an overall graft uptake rate of 88.6%, favoring cartilage slightly at 91.4% compared to 85.7% for fascia. Audiological improvements at both 3 and 6 months were comparable between groups, with cartilage showing slightly better long-term stability. In contrast, the study by Ferlito et al. involved 142 patients and highlighted that while both grafts resulted in significant post-operative improvements, cartilage provided better long-term stability. Lou et al.'s study of 134 patients found higher short- term graft success with cartilage, and Chen et al.'s extensive review of 4582 patients concluded that cartilage grafts had a higher overall success rate and better post- operative pure tone audiometry (PTA) outcomes, although temporal fascia grafts showed better air-bone gap (ABG) improvements. These findings collectively underscore the nuanced benefits of each graft type, with cartilage offering greater long-term durability and fascia demonstrating superior initial audiological gains. (15, 16, 17).

In conclusion, our study demonstrates that both sliced tragal cartilage and temporalis fascia grafts are effective in type 1 tympanoplasty for patients with large or subtotal perforations. However, sliced tragal cartilage shows a slightly higher graft uptake rate and long-term stability, while both grafts provide similar audiological improvements. The findings suggest that tragal cartilage may be preferable for achieving more consistent long-term outcomes, although the choice of graft should consider individual patient factors and surgical contexts. These insights contribute to enhancing surgical success rates and patient quality of life in tympanoplasty procedures.

Study Limitations

1. Sample Size: The study's sample size of 70 patients may limit the generalizability of the findings to the broader population.
2. Single-Center Study: Conducted at a single tertiary care hospital, which may not reflect the outcomes in different clinical settings or geographic locations.

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