| CTRI Number |
CTRI/2024/04/066472 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Jaw bone regeneration with different bone particles using Digital Dental X-ray |
|
Scientific Title of Study
|
Comparative Evaluation of Socket Preservation Technique with different bone grafts using Cone Beam Computed Tomography (CBCT) |
| 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. Pranavi J |
| Designation |
Post graduate |
| Affiliation |
KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES |
| Address |
Room no. 7, Third floor, Department of Periodontology, Karpaga Vinayaga Institute of Dental Sciences, GST road, Chinna kolambakkam, Palayanoor (PO), Chengalpattu (DT), Madhuranthakam.
Chennai
TAMIL NADU
603308
India |
| Phone |
9941592993 |
| Fax |
|
| Email |
pranavi@kids.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Lakshmiganthan |
| Designation |
Professor |
| Affiliation |
KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES |
| Address |
Room No.7, Third floor, Department of Periodontology, GST road, Chinna kolambakkam, Palayanoor (PO), Chengalpattu (DT), Madhuranthakam
Chennai
TAMIL NADU
603308
India |
| Phone |
9940724656 |
| Fax |
|
| Email |
drlakshmiganth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Pranavi J |
| Designation |
Post graduate |
| Affiliation |
KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES |
| Address |
Room No.7, Third floor, Department of Periodontology, Karpaga Vinayaga Institute of Dental Sciences, GST road, Chinna kolambakkam, Palayanoor (PO), Chengalpattu (DT), Madhuranthakam
Chennai
TAMIL NADU
603308
India |
| Phone |
9941592993 |
| Fax |
|
| Email |
pranavi@kids.edu.in |
|
|
Source of Monetary or Material Support
|
| Room No.7, Third floor, Department of Periodontology, Karpaga Vinayaga Institute of Dental Sciences, GST road, Chinna kolambakkam, Palayanoor (PO), Chengalpattu (DT), Madhuranthakam, Tamil Nadu- 603308, India. |
|
|
Primary Sponsor
|
| Name |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
Room No.7, Third floor, Department of Periodontology, Karpaga Vinayaga Institute of Dental Sciences, GST road, Chinna kolambakkam, Palayanoor (PO), Chengalpattu (DT), Madhuranthakam, Tamil Nadu- 603308, India. |
| 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 |
| Dr Pranavi J |
KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES |
Room no. 7, 3rd floor, Department of Periodontology, GST road, Chinna kolambakkam, Palayanoor (PO), Chengalpattu (DT), Madhuranthakam, Tamil Nadu-603308.
Kancheepuram
TAMIL NADU |
9941592993
pranavi@kids.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE - KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Empty Extraction socket |
Extraction socket allowed to heal without socket preservation
Duration : 6 months |
| Intervention |
Socket preservation |
Extraction followed by Socket preservation with Tooth graft and Xenograft
Duration : 6 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with teeth indicated for extraction and future implant therapy.
2.Systemically healthy individuals
3.Plaque Index and bleeding index - less than 20 %
4.Individuals with high compliance and good oral hygiene practice
Site criteria:
1.Single or multirooted teeth indicated for extraction- root fractures, failed endodontic treatment and advanced dental caries
2.Intact adjacent and opposing teeth.
3.Adequate width of keratinized tissue
4.Type I , II and III extraction socket morphology based on Extraction Defect Sounding (EDS) classification
|
|
| ExclusionCriteria |
| Details |
1.Individuals with any form of systemic illness
2.Individuals under radiation therapy to the head and neck region, prolonged corticosteroid therapy and other medications
3.Smokers
4.Pregnancy and lactation
5.Acute or chronic infection at the surgical site
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of socket preservation with autogenous bone grafts, xenografts |
At baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare different bone grafts with CBCT at baseline, 3 months and 6 months using the following parameters:
• Vertical ridge dimension (in mm)
• Horizontal ridge dimension (in mm)
• Density of alveolar bone
|
At baseline, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
12/05/2024 |
| 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="6"
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 study is a comparative study evaluating the effect of socket
preservation with autogenous tooth graft, xenograft graft using Cone Beam Computed Tomography at
baseline, 3 months and 6 months using following parameters: Vertical ridge dimension (in mm), Horizontal ridge dimension (in mm), Density of alveolar bone. |