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CTRI Number  CTRI/2018/02/011653 [Registered on: 01/02/2018] Trial Registered Prospectively
Last Modified On: 31/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   A surgical technique to repair cleft palate in little children 
Scientific Title of Study   A prospective study - one flap palatoplasty technique for complete unilateral cleft palate  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Patel Mohmed Talib Abdul Rashid 
Designation  Postgraduate Student 
Affiliation  Coorg Institute Coorg Institute of Dental Sciences 
Address  Room no 2 Department of Oral and Maxillofacial Surgery Coorg Institute of Dental Sciences Kanjithanda Kushalappa Campus Virajpet Karnataka 571218
.
Kodagu
KARNATAKA
571218
India 
Phone  8762272487  
Fax    
Email  talibpatel10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jayanth B S 
Designation  Professor and HOD department of Oral and Maxillofacial Surgery 
Affiliation  Coorg Institute of Dental Sciences 
Address  Room no 2 Department of Oral and Maxillofacial Surgery Coorg Institute of Dental Sciences Kanjithanda Kushalappa Campus Virajpet Karnataka 571218

Kodagu
KARNATAKA
571218
India 
Phone  9632519000  
Fax    
Email  jayanth2g@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jayanth B S 
Designation  Professor and HOD department of Oral and Maxillofacial Surgery 
Affiliation  Coorg Institute of Dental Sciences 
Address  Room no 2 Department of Oral and Maxillofacial Surgery Coorg Institute of Dental Sciences Kanjithanda Kushalappa Campus Virajpet Karnataka 571218

Kodagu
KARNATAKA
571218
India 
Phone  9632519000  
Fax    
Email  jayanth2g@gmail.com  
 
Source of Monetary or Material Support  
Coorg Institute of Dental Sciences Kanjithanda Kushalappa Campus Virajpet Karnataka 571218 
 
Primary Sponsor  
Name  Patel Mohmed Talib Abdul Rashid 
Address  Room no 2 Department of Oral and Maxillofacial Surgery Coorg Institute of Dental Sciences Kanjithanda Kushalappa Campus Virajpet Karnataka 571218 
Type of Sponsor  Other [Principal Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Patel Mohmed Talib Abdul Rashid  Coorg Institute Of Dental Sciences   Room no 2 Department of Oral and Maxillofacial Surgery Kanjithanda Kushalappa Campus Virajpet Karnataka 571218
Kodagu
KARNATAKA 
8762272487

talibpatel10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children of age 1 to 3 years of age suffering from primary cleft defect 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  Surgical Correction Of Primary Palate by One Flap Palatoplasty Technique   1. Surgical Incisions And Subperiosteal And Submucosal Dissection 2. Unilateral Flap Elevation Muscle Repair And Nasal Mucosa Closure 3.Oral Mucosa Closure Leaving Unilateral Raw Surface  
 
Inclusion Criteria  
Age From  12.00 Month(s)
Age To  3.00 Year(s)
Gender  Both 
Details  1. 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  
 
ExclusionCriteria 
Details  1. Patient who will not cooperate with follow-up schedule
2. Previously repaired cases of cleft palate  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the surgical outcome of one flap palatoplasty   within 2 years 
 
Secondary Outcome  
Outcome  TimePoints 
to assess the improvement in speech following surgery for cleft palate repair  within two years 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="0" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/02/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Study Yet to Commence 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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







 
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