| CTRI Number |
CTRI/2024/03/064825 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to evaluate the effectiveness of autogenous tooth graft for socket preservation |
|
Scientific Title of Study
|
A randomised prospective clinical trial for evaluation of clinical effectiveness of autogenous tooth graft in socket preservation which is a clinical,radiological and histological study. |
| Trial Acronym |
ATG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanya Singh |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Army college of dental sciences |
| Address |
Army college of dental sciences, jai jawahar nagar, chennapur, Secunderabad, Telangana, 500087
Medchal
TELANGANA
500087
India |
| Phone |
09309855206 |
| Fax |
|
| Email |
tanyasingh369tesla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNavaljeet Kaur |
| Designation |
Senior Lecturer |
| Affiliation |
Army college of dental sciences |
| Address |
Army college of dental sciences, jai jawahar nagar, chennapur, Secunderabad, Telangana, 500087
Medchal
TELANGANA
500087
India |
| Phone |
9876911090 |
| Fax |
|
| Email |
navaljeetkaurmann@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrK David Tyro |
| Designation |
Reader |
| Affiliation |
Army college of dental sciences |
| Address |
Army college of dental sciences, jai jawahar nagar, chennapur, Secunderabad, Telangana, 500087
Medchal
TELANGANA
500087
India |
| Phone |
9948930260 |
| Fax |
|
| Email |
kdavidtyro@gmail.com |
|
|
Source of Monetary or Material Support
|
| Army College of Dental Sciences |
|
|
Primary Sponsor
|
| Name |
Tanya Singh |
| Address |
Army College of Dental Sciences,Jai Jawahar Nagar, Chennapur, CRPF road, Secunderabad 500087, Telangana |
| 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 |
| DrTanya Singh |
Army college of dental sciences |
Department Of Oral and Maxillofacial Surgery, Room Number.6
Medchal
TELANGANA |
09309855206
tanyasingh369tesla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Army college of dental sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY HUMANS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
To evaluate the clinical , radiological and histological effectiveness of autogenous tooth graft in preserving the extracted alveolar socket |
To assess the effectiveness of autogenous tooth graft in preserving the extracted alveolar socket , using radiological segmental CBCT evaluation of socket width and socket height and histological evaluation using punch biopsy.
To prepare the site for future prosthetic rehabilitation and implant placement
The duration of the study is six months
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age between 20 and 50 years.
Systemically healthy patients.ASA 1,ASA 2
Patients who require tooth extraction due to localized periodontitis,trauma and tooth fracture.
Patient having a tooth indicated for extraction which could be used for autograft.
Patient who received instruction on the purpose of the clinical study and gave his /her consent.
|
|
| ExclusionCriteria |
| Details |
Systemic illness such as diabetes mellitus, cardiac diseases, immune-compromised , patients taking medications such as corticosteroids, calcium channel blocker or bisphosphonates which are known to interfere with the outcome.
Pregnant and lactating patients.
Grossly decayed and RCT treated teeth
Alcoholics and Smokers.
Patients who demonstrate poor oral hygiene maintenance.
Patient who has received radiation therapy.
Patient who has acute infections. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the effectiveness of autogenous tooth graft in preserving the extracted alveolar socket , using radiological segmental CBCT evaluation of socket width and socket height and histological evaluation using punch biopsy after 6 months.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To prepare the site for future prosthetic rehabilitation and implant placement |
6 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 1 |
|
Date of First Enrollment (India)
|
09/04/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The aim of the study is to evaluate the clinical , radiological and histological effectiveness of autogenous tooth graft in preserving the extracted alveolar socket.The purpose of this study is to preserve the alveolar dimension of the extracted alveolar socket by using autogenous tooth graft which will aid in successful accomplishment of future rehabilitation.The objective of the study is to assess the effectiveness of autogenous tooth graft in preserving the extracted alveolar socket , using radiological segmental CBCT evaluation of socket width and socket height and histological evaluation using punch biopsy after 6 months and prepare the site for future prosthetic rehabilitation and implant placement . Informed consent will be obtained.Extraction will be done under Local Anaesthesia using 2% Lignocaine and 1:80,000 Adrenaline.Preparation and sectioning of the teeth will be done.Grinding and Cleansing the particulate.Graft material will be obtained , placed in the socket and sutured.Radiographic evaluation: segmental Cone-beam computed tomography (CBCT). Radiographic assessment –Baseline -immediately ,postoperatively: 3month and 6month.Punch biopsy will be perfomed after 6 month.Histological analysis of new woven bone formation using hematoxylin and eosin stain will be done.
|