A surgical technique to repair cleft palate in little children
- Conditions
- Children of age 1 to 3 years of age suffering from primary cleft defect
- Registration Number
- CTRI/2018/02/011653
- Lead Sponsor
- Patel Mohmed Talib Abdul Rashid
- Brief Summary
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| The cleft lip and palate (CLP) is one of the most common congenital malformations in the human race, it is caused by lack of fusion of the embryonic facial processes. The anatomic impairment appears as a cleft lip and / or palate, and it may occur with a frequency of 1:700 births.
Surgical repair of primary cleft palate is a procedure for anatomical and functional reconstruction of this structure,which is performed most commonly by two flap palatoplasty technique introduced by “BARDACH†more than 45 years ago and is most commonly used procedure in United states .
The main goal of palatoplasty is not only restoring the anatomy of the palate , but also promote an adequate velopharyngeal function that consequently provides conditions for the production of speech but the main disadvantage associated is maxillary growth disturbance secondary to surgical scarring following palatal repair.Further following two flap palatoplasty results in bilateral raw surface left for healing by granulation tissue formation and the associated increased scarring causing increased maxillary growth disturbance.
Thus a surgical technique using only one mucoperiosteal flap from the noncleft side was introduced by ROSSEL-PERRY et al in the year 2015 at lima, peru (1-flap method) reducing the extent of the surgery and its potential nondesirable effects over the palate. There is a paucity of literature supporting the outcome of this technique. Hence we recommend studies to evaluate this technique for its appropriateness to be an alternative for palatal repair in patients with complete unilateral cleft palate with minimal side effects. The purpose of this study is to evaluate the utility of this technique for unilateral cleft palate repair.
PROCEDURE :
Patient consent will be obtained prior to the procedure
- These study include 10 healthy patients who are non syndromic ,irrespective of sex has to undergo for surgery for one flap palatoplasty for primary cleft palate deformity at age group of 12 months to 3 years at oral and maxillofacial unit Coorg Institue of Dental sciences
- All the patients will be undergoing routine hemogram investigation before the procedure . they will be prepared in a standard manner and taken up under proper aseptic condition for the procedure
- Patient will be given standard antibiotics of beta lactam/cephalosporin group as well as analgesic post –operatively
- This study will contain assessment of fistula site ( pittsburgh classification system ) velopharyngeal dysfunction evaluated by speech pathologist henningson et al flap blood supply is assessed according to journal of wound care and assessment of infection post -operatively
- assessment of palatal index grading pre-operatively based on Percy -Rossell -Perry et al
- assessment of surgical time intra -operatively
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 10
- Patients Who Has To Undergo Surgery For Unilateral Cleft lip And Palate 2.
- Patient Who Are non syndromic ,irrespective of the sex are included in the study 3.
- Age group-12 months to 3 years.
- Patient who will not cooperate with follow-up schedule 2.
- Previously repaired cases of cleft palate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the surgical outcome of one flap palatoplasty within 2 years
- Secondary Outcome Measures
Name Time Method to assess the improvement in speech following surgery for cleft palate repair within two years
Trial Locations
- Locations (1)
Coorg Institute Of Dental Sciences
🇮🇳Kodagu, KARNATAKA, India
Coorg Institute Of Dental Sciences🇮🇳Kodagu, KARNATAKA, IndiaPatel Mohmed Talib Abdul RashidPrincipal investigator8762272487talibpatel10@gmail.com