| CTRI Number |
CTRI/2023/07/055895 [Registered on: 31/07/2023] Trial Registered Prospectively |
| Last Modified On: |
02/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative clinical and radiographic evaluation of efficacy of demineralized bone matrix versus demineralized freeze dried bone allograft in treatment of apical location of the base of the pocket relative to the bone crest: a randomized controlled clinical trial |
|
Scientific Title of Study
|
Comparative clinical and radiographic evaluation of efficacy of demineralized bone matrix versus demineralized freeze dried bone allograft in treatment of infrabony defects: a randomized controlled clinical trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rishabh Trivedi |
| Designation |
PG Student |
| Affiliation |
Government Dental College and Hospital |
| Address |
Room No 112, First Floor, Department of Periodontology
Jamnagar
GUJARAT
361008
India |
| Phone |
7600554887 |
| Fax |
|
| Email |
rishabhtrivedi169@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayana Patel |
| Designation |
PG Guide, Professor and Head |
| Affiliation |
Government Dental College and Hospital |
| Address |
Room No 112, First Floor, Department of Periodontology
Jamnagar
GUJARAT
361008
India |
| Phone |
7600554887 |
| Fax |
|
| Email |
drnayanagpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rishabh Trivedi |
| Designation |
PG Student |
| Affiliation |
Government Dental College and Hospital |
| Address |
Room No 112, First Floor, Department of Periodontology
Jamnagar
GUJARAT
361008
India |
| Phone |
7600554887 |
| Fax |
|
| Email |
rishabhtrivedi169@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Jamnagar |
|
|
Primary Sponsor
|
| Name |
Dr Rishabh Trivedi |
| Address |
Room No 112, First Floor, Department of Periodontology, Government Dental College and Hospital, Jamnagar |
| 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 |
| Dr Rishabh Trivedi |
Government Dental College and Hospital |
Room No 112, First Floor, Department of Periodontology
Jamnagar
GUJARAT |
7600554887
rishabhtrivedi169@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, M. P. Shah Govt. Medical College & Guru Gobindsingh Hospital, Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Demineralized Bone Matrix |
Commercially available as Osseograft TM is used to fill the infrabony defect at the time of surgery and the patient is followed up for 6 months |
| Comparator Agent |
Demineralized Freeze Dried Bone Allograft |
Demineralized Freeze Dried Bone Allograft is used to fill the infrabony defect at the time of surgery and the patient is followed up for 6 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of both sexes having no systemic conditions that would contraindicate
routine periodontal procedures.
2. Age More than or equal to 25 years of age, with no history of any periodontal surgery in the past 1
year.
3. The sites having radiographic evidence of angular bone loss More than or equal to 3 mm deep and
probing depth of More than or equal to 5 mm. |
|
| ExclusionCriteria |
| Details |
1. Participants who had received periodontal flap/regenerative therapy within the
past 1 year.
2. Patients with deleterious oral habits such as smoking, tobacco chewing.
3. Pregnant and Lactating mothers.
4. Patients who were on antibiotic and nonsteroidal anti-inflammatory drugs within
the past 1 year. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plaque index (PI), Gingival index (GI), Probing pocket depth (PD), Relative attachment level (RAL) |
At baseline, 1 month and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiographic evaluation |
Baseline
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/08/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be done to evaluate clinical & radiographic efficacy of Demineralized Bone Matrix in comparison of that of Demineralized Freeze Dried Bone Allograft in treatment of infrabony defects. It will be a randomized controlled clinical trial. Total treatment sites will be 30 with chronic periodontitis. After 3-4 weeks of scaling, patients will be called for surgical procedure. After incision, reflection and degranulation; the infrabony defects will be filled with either Demineralized Bone Matrix or Demineralized Freeze Dried Bone Allograft according to the inclusion groups. The flaps will be sutured with 4 0 silk sutures. Plaque index, gingival index, pocket probing depth and clinical attachment level will be recorded preoperatively and postoperatively. Radiographs will be taken preoperatively and postoperatively. |