| CTRI Number |
CTRI/2025/03/081760 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two Techniques for Removal of Severely Decayed Upper Third Molar Teeth. |
|
Scientific Title of Study
|
Traditional Buccal Elevation Technique vs Palatal Elevation Technique (PET) for Intra-alveolar Extraction of Grossly Decayed Maxillary Third Molars: A Comparative 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 |
Kavila Vivek Manohar |
| Designation |
Associate Professor |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
Room.No:5, Department of Oral & Maxillofacial Surgery, GITAM Dental College And Hospital.
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
8179803202 |
| Fax |
|
| Email |
vkavila@gitam.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Kavila Vivek Manohar |
| Designation |
Associate Professor |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
Room.No:5, Department of Oral and Maxillofacial Surgery, GITAM Dental College And Hospital
ANDHRA PRADESH
530045
India |
| Phone |
8179803202 |
| Fax |
|
| Email |
vkavila@gitam.edu |
|
Details of Contact Person
Public Query
|
| Name |
Kavila Vivek Manohar |
| Designation |
Associate Professor |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
Room.No:5, Department of Oral and Maxillofacial Surgery, GITAM Dental College And Hospital.
ANDHRA PRADESH
530045
India |
| Phone |
8179803202 |
| Fax |
|
| Email |
vkavila@gitam.edu |
|
|
Source of Monetary or Material Support
|
| Dr.N.T.R University of Health Sciences, Near Siddhartha Medical College, Beside New Government General Hospital, Ramavarappadu, Vijayawada, Andhra Pradesh-520008, India |
|
|
Primary Sponsor
|
| Name |
Dr.N.T.R University of Health Sciences |
| Address |
Near Siddhartha Medical College, Beside New Government General Hospital, Ramavarappadu, Vijayawada, 520008 |
| Type of Sponsor |
Other [Affiliated University] |
|
|
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 |
| Kilaparthi Lochana |
GITAM Dental College & Hospital |
Room.No:5,Department of Oral & Maxillofacial Surgery.
Visakhapatnam
ANDHRA PRADESH |
9381561933
lochanak2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GITAM DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Grossly decayed maxillary third molar teeth management |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Buccal Elevation Technique |
The buccal elevation technique is the comparator treatment technique used to compare with the new technique called palatal elevation technique for intra-alveolar extraction of grossly decayed maxillary third molars. The intervention takes upto 10-15 minutes. |
| Intervention |
Palatal elevation technique |
Newly introduced technique for extraction of grossly decayed maxillary third molars. the elevator in this technique is engaged palatally and luxation is carried out. The intervention takes upto 10-15 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients within the age range of 18-60 years.
2.Patients with at least one grossly decayed maxillary third molar indicated for extraction.
3.Patients with no relevant medical history that contraindicates tooth extraction.
4.Patients with adequate inter incisal opening.
5. Patients with thick and inextensible cheeks.
|
|
| ExclusionCriteria |
| Details |
1.Patients whose mouth opening is severely restricted with underlying conditions like oral submucous fibrosis, myofacial pain dysfunction syndrome, internal derangement of TMJ, myositis of masticatory muscles.
2.Patients taking medications affecting bone remodelling process (i.e. bisphosphonates)
3.Patients with buccally tipped maxillary third molars.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The novel palatal elevation technique would be an effective alternative for buccal elevation technique for extraction of grossly decayed maxillary third molars in terms of swiftness and intraoperative complication rate is less with PET when compared to traditional buccal elevation technique. |
No time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The post-operative complication rate would be less with PET compared to traditional buccal elevation technique |
At the end of 7 days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vivekmanohar305@gmail.com].
- For how long will this data be available start date provided 01-03-2025 and end date provided 31-12-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study aims to evaluate the efficacy of the newly modified palatal elevation technique with already exisisting buccal elevation technique for closed extraction of grossly decayed maxillary third molars. The techniques are evaluated based on three parameters which are 1) time required for extraction 2)intra-operative complications and 3) postoperative complications. |