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Comparison of two patient group with two different types of graft that will be used for Type 1 tympanoplasty - a type of Tympanic membrane perforation repair

Comparison of Temporalis Fascia Graft versus Tragal Composite Graft in Type 1 Tympanoplasty: A Randomized Control Trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103529
Enrollment
108
Registered
2026-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H720- Central perforation of tympanic membrane

Interventions

Intervention1: Type 1 tympanoplasty with Tragal composite Graft: Type 1 Tympanoplasty involves repair of tympanic membrane alone when the middle ear mucosa is normal with intact ossicular chain.A type

Sponsors

Attadeep Bose
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18 years and above 2.Central perforation of tympanic membrane irrespective of cause of perforation 3. A dry ear for at least 6 weeks.

Exclusion criteria

Exclusion criteria: 1.patient with near total or total perforation 2.Revision Tympanoplasty 3.Patient with chronic otitis media squamousal type with cholesteatoma or retraction pockets 4.Sensorineural hearing loss.

Design outcomes

Primary

MeasureTime frame
1.Graft uptake Rate at 3rd post operative month , 6th post operative month and at 1 year. 2. Post operative hearing outcome in terms of air bone gap at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz at 3rd post operative month, 6th post operative month and at 1 year .Timepoint: 1.Graft uptake Rate at 3rd post operative month , 6th post operative month and at 1 year. 2. Post operative hearing outcome in terms of air bone gap at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz at 3rd post operative month, 6th post operative month and at 1 year .

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactProf Dr Sudhiranjan Thingbaijam

Regional Institute Of Medical Sciences

sudhirthdr@gmail.com9862189195

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026