| CTRI Number |
CTRI/2020/02/023489 [Registered on: 20/02/2020] Trial Registered Prospectively |
| Last Modified On: |
07/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of dimensional changes in the bone following extraction with and without using bone graft - A clinical study |
|
Scientific Title of Study
|
Evaluation of dimensional changes in the alveolar ridge following tooth extraction with and without using decalcified freeze dried bone allograft - A clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Farrukh Faraz |
| Designation |
Associate Professor |
| Affiliation |
Department of Periodontics, Maulana Azad Institute of Dental Sciences |
| Address |
Room no: 614
Department of Periodontics
Maulana Azad Institute of Dental Sciences
Maulana Azad Medical College Campus, Bahadur Shah Zafar Marg, New Delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
9654700981 |
| Fax |
|
| Email |
farrukhfaraz@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Farrukh Faraz |
| Designation |
Associate Professor |
| Affiliation |
Department of Periodontics, Maulana Azad Institute of Dental Sciences |
| Address |
Room no: 614
Department of Periodontics
Maulana Azad Institute of Dental Sciences
Maulana Azad Medical College Campus, Bahadur Shah Zafar Marg, New Delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
9654700981 |
| Fax |
|
| Email |
farrukhfaraz@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanika Makker |
| Designation |
Senior Research Fellow |
| Affiliation |
Department of Periodontics, Maulana Azad Institute of Dental Sciences |
| Address |
Department of Periodontics
Maulana Azad Institute of Dental Sciences
Maulana Azad Medical College Campus, Bahadur Shah Zafar Marg, New Delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
9899248191 |
| Fax |
|
| Email |
kanikamakker91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research |
|
|
Primary Sponsor
|
| Name |
Department of Health Research |
| Address |
2nd Floor, IRCS Building, Red Cross Road, New Delhi, Delhi 110003 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Dr Farrukh Faraz |
Maulana Azad Institute of Dental Sciences |
Department of Periodontics
6th Floor
Maulana Azad Institute of Dental Sciences, Maulana Azad Medical College Campus, Bahadur Shah Zafar Marg, New Delhi - 110002
New Delhi
DELHI |
9654700981
farrukhfaraz@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of MAIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bone graft |
Decalcified freeze dried bone allograft |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients having teeth with poor prognosis that require extraction |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases (eg: uncontrolled diabetes, hypertension) which contraindicate surgery
Pregnant and lactating mothers or those planning a pregnancy
Smokers
Patients with bleeding disorders.
Patients suffering from allergic conditions or history of allergies.
Patients on long term systemic antibiotics or non-steroidal anti-inflammatory drugs
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Post-extraction horizontal and vertical dimension of the alveolar ridge as measured from a pre-determined reference point may be influenced with the intervention i.e. addition of bone graft |
Ridge Parameters will be assessed at baseline following extraction and then 6 months later at the time of implant placement |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
24/02/2020 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background:
Post-extraction alveolar bone resorption renders the ridge inadequate for the placement of prosthetically driven implants and pontics which in turn leads to unsatisfactory aesthetics or function of the prosthesis. The present clinical trial is an endeavour to investigate the role of bone grafts in mitigating the effects of resorption and allowing successful rehabilitation.
Aim:
1. To investigate the possibility of using bone graft for the formation of functional alveolar bone. 2. To evaluate if implant placement is possible after bone grafting Methodology: Forty subjects requiring extraction for teeth with poor prognosis will be included in the randomised controlled clinical trial. Extraction will be performed a-traumatically and ridge measurements taken using a pre-fabricated stent. A re-entry procedure will be undertaken 6 months later for implant placement. Clinical and Ridge parameters will be re-recorded, tabulated and statistically analysed.
|