| CTRI Number |
CTRI/2025/03/082891 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of primary stability of implant placed at extraction socket preserved with autogenous dentin graft versus to that in unassisted socket healing |
|
Scientific Title of Study
|
Evaluation of primary stability of implant placed at socket preservation site using autogenous dentin graft and conventional healed socket sites: a comparative clinico-radiographic study |
| 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 Shivangi Singh |
| Designation |
PG Student |
| Affiliation |
Department of Periodontology, Government College of Dentistry, Indore |
| Address |
158, Bhatia PG Rooms, Jaora compound, Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
6263302479 |
| Fax |
|
| Email |
shivangi4707@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhu S Ratre |
| Designation |
HOD, Department of Periodontology |
| Affiliation |
Govt. College of Dentistry, Indore |
| Address |
Govt. College of Dentistry, Sardar Patel Marg, Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
9406928976 |
| Fax |
|
| Email |
smadhu16feb@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhu S Ratre |
| Designation |
HOD, Department of Periodontology |
| Affiliation |
Govt. College of Dentistry, Indore |
| Address |
Govt. College of Dentistry, Sardar Patel Marg, Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
9406928976 |
| Fax |
|
| Email |
smadhu16feb@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT COLLEGE OF DENTISTRY, INDORE, M.P. 452001, INDIA |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT COLLEGE OF DENTISTRY INDORE |
| Address |
ROOM NO. 10, DEPARTMENT OF PERIODONTOLOGY, GOVERNMENT COLLEGE OF DENTISTRY, INDORE OPPOSITE M. Y. HOSPITAL, SARDAR PATEL MARG, INDORE |
| Type of Sponsor |
Government medical college |
|
|
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 SHIVANGI SINGH |
GOVERNMENT COLLEGE OF DENTISTRY INDORE |
Room no. 10, Department of Periodontology, 2nd floor, Govt. College of Dentistry, Sardar Patel Marg, Opposite M Y Hospital, Indore
Indore
MADHYA PRADESH |
6263302479
Shivangi4707@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government College of Dentistry, Indore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1, Conventionally healed sites |
Conventionally healed single tooth edentulous site will be planned for Dental implant placement. Dental implant placement around 6 months after extraction. Primary Stability will be assessed with RFA Device immediately after implant placement |
| Intervention |
Group 2: Socket preservation using Autogenous Dentin graft |
after extraction, autogenous dentin graft will be prepared and socket preservation will be done. After 6 months of socket preservation implant placement will be done. Primary Stability will be assessed with RFA Device immediately after implant placement |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
GROUP 1
(1) Patients having a tooth indicated for extraction with adjacent teeth present; in anterior and/or posterior area in any of the jaws, with history of extraction of around 6 months
(2) Adequate bone volume to accommodate an implant without the need for bone augmentation.
GROUP 2
(1) Tooth indicated for extraction due to trauma, caries, iatrogenic errors, orthodontic reasons
COMMON CRITERIA
1) Age:20 to 50 years male /female, systemically healthy
2) Able to understand and sign an informed consent
3) Patient willing for dental implant placement with delayed prothesis.
4) Who will be ready to have their progress followed for at least 9 months.
5) Maintainable oral hygiene
|
|
| ExclusionCriteria |
| Details |
1) Patient requiring extraction of root canal treated teeth and teeth with periapical pathology.
2) Extraction sites with a partial or complete deficiency of buccal bone plate.
3) If any complication arises during treatment that requires additional soft tissue or hard tissue augmentation for implant placement
4) History of allergy or systemic diseases such as diabetic mellitus, immunocompromising diseases, blood dyscrasias, cardiovascular disease, renal disease etc.
5) Patient with systemic medication like long-term steroids, amino bisphosphonate therapy, anticoagulants, anticonvulsants, long term radiation therapy.
6) Presence of active periodontal disease.
7) Smokers and/ or consuming tobacco in any form.
8) Acute infection in the failing tooth.
9) Unwillingness to return for the follow-up examination.
|
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of primary stability of implant placed at socket preservation site using autogenous dentin graft and conventional healed socket sites: a comparative clinico-radiographic study |
Evaluation of primary stability of implant 6 months after grafting with autogenous dentin grafted site in group 2 and 6 months after extraction in conventional healed socket sites |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the stability of implant at 3 months post operatively in both groups |
3 months post operatively |
| To evaluate hard tissue changes around dental implant in both groups |
during implant placement and 3 month post operative status |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="0"
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
|
- Dental extractions reduce the dimensions of alveolar bone significantly. In order to reduce post extraction bone loss, socket grafting could result in the maintenance of sufficient bone volume for dental implant placement in desired position. Autogenous dentin grafts (ADG) can be used for socket preservation because of their properties of osteo-induction and osteo-conduction. • In group 1, conventionally healed single tooth edentulous site will be planned for implant placement around 6 months after extraction
- In group 2 after extraction, autogenous dentin graft will be prepared and socket preservation will be done. After 6 months of socket preservation implant placement will be done
- Implant placement will be done in both groups following standard protocols and Primary Stability will be assessed with RFA Device immediately after implant placement
- Clinical and radiological parameters will be recorded post-operatively at 3 months follow up. CBCT will be done just before implant placement and 3 months post operatively
|