| CTRI Number |
CTRI/2020/10/028467 [Registered on: 19/10/2020] Trial Registered Prospectively |
| Last Modified On: |
12/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of periodontal defects with autogenous tooth graft vs demineralised bone matrix |
|
Scientific Title of Study
|
Comparative evaluation of autogenous tooth graft vs demineralized bone matrix in the treatment of periodontal osseous defects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D jayasri varalakshmi |
| Designation |
pg student |
| Affiliation |
st joseph dental college |
| Address |
department of periodontics
st joseph dental college duggirala eluru
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9347477355 |
| Fax |
|
| Email |
22jayasree.lucky@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M narendra babu |
| Designation |
professor |
| Affiliation |
st joseph dental college |
| Address |
st joseph dental college duggirala eluru
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9347477355 |
| Fax |
|
| Email |
plaque3456@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
D jayasri varalakshmi |
| Designation |
pg student |
| Affiliation |
St joseph dental college |
| Address |
Department of periodontics
st joseph dental college duggirala eluru
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9347477355 |
| Fax |
|
| Email |
22jayasree.lucky@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontics
st joseph dental college, duggirala,
eluru
|
|
|
Primary Sponsor
|
| Name |
st joseph dental college Department of periodontics |
| Address |
st joseph dental college duggirala eluru |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| d jayasri varalakshmi |
st joseph dental college |
Department of periodontics
West Godavari
ANDHRA PRADESH |
9347477355
22jayasree.lucky@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institution ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Periodontal osseous defects |
Bone formation is evaluated after 9 months |
| Intervention |
Periodontal osseous defects |
Bone regeneration is evaluated after 9 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients having a periodontal pocket with probing depth ≥5 mm
Clinical attachment loss (CAL) ≥5 mm
Radiographic evidence of periodontal osseous defects
Patient having any tooth meant for extraction.
|
|
| ExclusionCriteria |
| Details |
Those who had undergone any type of regenerative periodontal therapy 6 months prior to the initial examination
Patients with any systemic illness
Patients who are pregnant or lactating, allergic to materials and drugs used or prescribed in this study
History of smoking and alcohol |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bone formation at 6 months |
Bone formation at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bone formation |
9 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
26/10/2020 |
| 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="1"
Months="1"
Days="10" |
|
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)?
Response - NO
|
|
Brief Summary
|
The current study is a double masked randomized clinical trial. A total of 30 defects in patients of age 25 to 55 years were assigned randomly into two groups. Autogenous tooth graft is placed in 15 defects. Demineralized bone matrix is placed in 15 defects. Clinical measurements are recorded at baseline and 9 months post-operatively. Cone beam computed tomography can be used to assess the bone formation |