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
|
|
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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Unilateral cleft lip and palate patients, |
|
Intervention / Comparator Agent
|
|
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. |