| CTRI Number |
CTRI/2015/09/006213 [Registered on: 28/09/2015] Trial Registered Retrospectively |
| Last Modified On: |
27/08/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
COMPARATIVE EVALUATION OF DIFFERENT BONE GRAFTS IN THE MANAGEMENT OF PERIODONTAL DISEASE(Diseases of the gums) |
|
Scientific Title of Study
|
Comparative Evaluation of Hydroxyapatite and Bioactive glass In the Treatment of 3-Wall Intrabony Defects in Chronic Periodontitis: A Multicentric Randomized Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSmitha |
| Designation |
Reader |
| Affiliation |
Government dental college and Research Institute,Bangalore |
| Address |
Government Dental college and Research Institute,Fort Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
periosmitha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSuman basavraj |
| Designation |
Professor |
| Affiliation |
Sri Ganga sagar Dental college,Gangan sagar |
| Address |
Sri Ganga sagar Dental college,Gangan sagar ,Rajasthan
Ganganagar
RAJASTHAN
Sri Ganga sagar Dental college,Gangan sagar ,Rajasthan
Ganganagar
RAJASTHAN
Ganganagar
RAJASTHAN
335 001
India |
| Phone |
|
| Fax |
|
| Email |
smisathya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSmitha |
| Designation |
Reader |
| Affiliation |
Government dental college and Research Institute,Bangalore |
| Address |
Government Dental college and Research Institute,Fort Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
periosmitha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [None] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSuman Basavraj |
Government Dental college and Research Institute |
Government Dental college and Research Institute,Bangalore
Bangalore
KARNATAKA |
9449630572
smisathya@gmail.com |
| Dr Suman Basavraj |
Sri Ganga Sagar Dental college,Rajasthan |
Sri Ganga sagar Dental college,Gangan sagar ,Rajasthan
Ganganagar
RAJASTHAN |
9945551564
smisathya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Government Dental college and Research Institute |
Approved |
| Sri Gangaraj Dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Systemically Healthy,But having Chronic Periodontitis , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bioactive glass with open flap debridement |
Alloplastic bone replacement graft |
| Comparator Agent |
Hydroxyapatitite with open flap debridement |
Alloplastic Bone replacement graft |
| Intervention |
Open flap debridement alone |
surgical intervention with open flap debridement |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
11The inclusion criteria included the presence of Systemically Healthy patients with Chronic periodontis requiring surgery with 3-wall Intra bony defect >3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPA]) and a defect angle >37 ͦ , along with an inter proximal probing depth (PD) >5 mm after Phase I therapy (scaling and root planing [SRP]) in asymptomatic teeth |
|
| ExclusionCriteria |
| Details |
Those having unacceptable oral hygiene (plaque index [PI] 12 >1.5) after reevaluation of Phase I therapy were also excluded from the study. In addition, teeth with furcation defects or nonvitality and/or mobility of at least grade II were also excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Radiographic percentage of defect fill |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Probing Depth and Clinical attachment level |
6 months |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
06/08/1998 |
| 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="15"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
YET TO BE PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The ultimate goal of periodontal therapy remains to provide a dentition that remains in health and comfort for the life of the patient.This goal is now within the reach in patients with desrtuctive periodontitis,since the periodontal attachment apparatus can be regenerated in intra bony defects implanted by various biocompatible materials. This present multi centric study aims to explore the clinical and radiographic effectiveness of two alloplastic materials,hydroxyapatite and bioactive glass in the treatment of 3-wall intrabony defects in patients with chronic periodontitis |