| CTRI Number |
CTRI/2024/11/076550 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
3D Imaging Study of How to Preserve a Tooth Socket After Extraction Using Two Types of Bone Grafts |
|
Scientific Title of Study
|
CBCT evaluation of socket preservation: A comparative study of Osseograft and Bio-Oss |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varun Batra |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Institute Of Medical And Techinal Sciences,Saveetha Dental College |
| Address |
Clinc 25,Department of periodontics, 4th floor, Saveetha Dental College,162 Poonamallee High Rd, Velappanchavadi,Chennai Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
8445528230 |
| Fax |
|
| Email |
152305005.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JaiganeshR |
| Designation |
Professor and Head |
| Affiliation |
Saveetha Institute Of Medical And Techinal Sciences,Saveetha Dental College |
| Address |
Clinc 25,Department of periodontics, 4th floor, Saveetha Dental College,162 Poonamallee High Rd, Velappanchavadi,Chennai Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9840443463 |
| Fax |
|
| Email |
jaiganeshr@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr JaiganeshR |
| Designation |
Professor and Head |
| Affiliation |
Saveetha Institute Of Medical And Techinal Sciences,Saveetha Dental College |
| Address |
Clinc 25,Department of periodontics, 4th floor, Saveetha Dental College,162 Poonamallee High Rd, Velappanchavadi,Chennai Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9840443463 |
| Fax |
|
| Email |
jaiganeshr@saveetha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College |
| Address |
Clinc 25,Department of periodontics, 4th floor, Saveetha Dental College,162 Poonamallee High Rd, Velappanchavadi,Chennai Tamil Nadu 600077 |
| 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 |
| DrVarun Batra |
Saveetha Dental College |
Clinc 25,Department of periodontics, 4th floor, Saveetha Dental College,162 Poonamallee High Rd, Velappanchavadi,Chennai Tamil Nadu 600077
Chennai
TAMIL NADU |
08445528230
152305005.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional human ethical committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K063||Horizontal alveolar bone loss, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1- Bio-Oss
|
Bio-Oss is xenogenic graft material that can be used as bone substitute and helps in bone regeneration. After tooth extraction material is packed inside the socket and allow it to heal for a time period of 3 to 6 months. So that we can preserve the extraction socket and we can get sufficient bone for implant placement |
| Comparator Agent |
Group 2 - Osseograft |
osseograft is xenogenic graft material used for bone regenration. After tooth extraction material is packed inside the socket and allow it to heal for a time period of 3 to 6 months. So that we can preserve the extraction socket and we can get sufficient bone for implant placement l. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
patient having unrestorabe tooth,periodontally compromised tooth with grade three mobility indicated for extraction
|
|
| ExclusionCriteria |
| Details |
patient having systemic disease such as diabetes
patient having habit of cigarette smoking and tobacco chewing
pregnant and lactating mothers
patients under mediction such as bisphosphonates |
|
|
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, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the change in the horizontal bone width such as mesio-distal and bucco-lingual dimension of the socket |
3-6 months post extraction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the quality of the bone |
3months |
|
|
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 2 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This randomized controlled trial aimed to compare the effectiveness of Osseograft and BioOss in preserving alveolar ridge dimensions after tooth extraction using Cone Beam Computed Tomography (CBCT). The study involved 30 extraction sockets from 20 participants, randomly assigned to either the Osseograft or Bio Oss group. Following atraumatic extraction, the respective graft material was placed in the sockets, and the initial socket dimensions were recorded, both bucco lingually and mesio distally. After three months, CBCT scans were performed to assess changes in ridge dimensions, with primary outcomes focusing on the preservation of horizontal bone width. |