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CTRI Number  CTRI/2018/04/013110 [Registered on: 09/04/2018] Trial Registered Retrospectively
Last Modified On: 18/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Assessment of secondary alveolar bone grafting in cleft lip and palate patients using 3 dimensional cone beam computed tomography 
Scientific Title of Study   Evaluation of autogenous secondary alveolar bone graft using cbct in patients with unilateral cleft lip and palate 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Joseph Jose 
Designation  Post Graduate student 
Affiliation  Institute of Dental Studies and Technologies 
Address  Institute of Dental Studies and Technologies Kadrabad Modinagar Ghaziabad Uttar Pradesh
Sushanth City, Sector 3 Flat number 39 NH 58 Near Subharathi
Ghaziabad
UTTAR PRADESH
201204
India 
Phone  8979206363  
Fax    
Email  josephjose277@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Amit Kumar Srivastava 
Designation  Reader 
Affiliation  Institute of Dental Studies and Technologies Kadrabad Modinagar Ghaziabad Uttar Pradesh 
Address  Institute of Dental Studies and Technologies Kadrabad Modinagar Ghaziabad Uttar Pradesh
Institute of Dental Studies and Technologies Kadrabad Modinagar Ghaziabad Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201204
India 
Phone  8979030695  
Fax    
Email  srivastavamit0224@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Joseph Jose 
Designation  Post Graduate student 
Affiliation  Institute of Dental Studies and Technologies Kadrabad Modinagar Ghaziabad Uttar Pradesh 
Address  Institute of Dental Studies and Technologies Kadrabad Modinagar Ghaziabad Uttar Pradesh
Sushanth City, Sector 3 Flat number 39 NH 58 Near Subharathi
Ghaziabad
UTTAR PRADESH
201204
India 
Phone  8979206363  
Fax    
Email  josephjose277@yahoo.com  
 
Source of Monetary or Material Support  
self-funded 
 
Primary Sponsor  
Name  Joseph Jose 
Address  IDST Dental College Kadrabad Modinagar Ghaziabad Uttar Pradesh Pin: 201204 
Type of Sponsor  Other [Self] 
 
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 
Joseph Jose  Institute of dental studies and technologies  Institute of Dental Studies and Technologies Kadrabad Modinagar Ghaziabad Uttar Pradesh Pin: 201201
Ghaziabad
UTTAR PRADESH 
8979206363

josephjose277@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of dental studies and technologies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Unilateral cleft lip and palate patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Patients with complete unilateral cleft lip and palate
2.Age group between 7 to 12 years.
 
 
ExclusionCriteria 
Details  1.Patients with bilateral cleft and incomplete clefts
2.There should not be any associated syndromes
3.There should not be any bone pathology.
4.Concurrent use of corticosteroids or immunosuppressive agents.
5.Pathological fractures.
6.Pre-existing vascular disease.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Secondary alveolar bone grafting was done in unilateral cleft lip and palate patients. CBCT scans were taken pre and post bone garfting  T0: before bone grafting
 
 
Secondary Outcome  
Outcome  TimePoints 
Evalaution based 2D and 3D radiographic scales 80% acceptable outcome and 20% unacceptable outcome was achieved.On CBCT evaluation preoperative cleft volume was reduced at 3 months after bone grafting and further reduced at 6 months after bone grafting. Percentage of bone fill increased from 3 months to 6 months. Average density of bone graft was reduced from 3 months to 6 months after bone grafting.  T1: 3 months after bone grafting
T2: 6 months after bone grafting 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/11/2015 
Date of Study Completion (India) 23/05/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="21" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Various methods of assessing the success of bone grafts have been proposed for the evaluation of secondary alveolar bone grafting in cleft patients. CBCT is more precise and reliable method compared to two dimensional radiographs to evaluate the size of the alveolar cleft defect, position and level of bone on adjacent teeth and presence of supernumerary teeth. Evaluation based on CBCT gives a better understanding of the defect for the surgeon and orthodontist which helps in treatment plan. Assessment of the bone fill should ideally be carried out at least 3 months after the bone grafting as grafted bone transforms into normal trabecular bone by 3 months. Resorption (height loss) of the bone graft occurs within 3 to 6 months after secondary alveolar bone grafting. The conclusions of the present study are: 1) 2D scales such as Enemark’s and Chelsea analysis and 3D scale proposed by A J Forte showed 80% of the patients had an acceptable outcome and 20% patients had an unacceptable outcome after secondary alveolar bone grafting. 2) On CBCT evaluation preoperative cleft volume was 0.88 ± 0.49 cm3 which was reduced to .2±.18 cm3 at 3 months and further reduced to .16±.18 cm3 at 6 months with percentage of bone fill 76.23% and 82.13 % at 3 months and 6 months respectively. There was an absolute difference of 28.71% of bone fill between 3 months and 6 months. 3) The average density of the unaffected side was 752.26± 66.11 HU and coincides with normal radiographic bone density of maxilla, where bone density D3 (350-850HU). Average density of bone graft was 375.38 ± 148.18 HU at 3 months which was reduced to 347.57 ± 137.10 HU at 6 months.

 
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