| CTRI Number |
CTRI/2026/03/105483 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing two methods to improve bone healing after lower wisdom tooth removal |
|
Scientific Title of Study
|
A comparison of platelet rich plasma and synthetic graft with platelet rich plasma in bone regeneration of impacted mesioangular mandibular third molar extraction sites - Split mouth 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 Rangith |
| Designation |
Junior Resident |
| Affiliation |
Government Dental College, Kottayam, Kerala. |
| Address |
Room No 103, Department of OMFS, Government Dental College, Kottayam, Kerala.
Kottayam
KERALA
686008
India |
| Phone |
8778919585 |
| Fax |
|
| Email |
rangithsr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Antony P G |
| Designation |
Additional Professor |
| Affiliation |
Government Dental College, Kottayam, Kerala. |
| Address |
Room No 103, Department of OMFS, Government Dental College, Kottayam, Kerala.
Kottayam
KERALA
686008
India |
| Phone |
9447258110 |
| Fax |
|
| Email |
drpgantony@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rangith |
| Designation |
Junior Resident |
| Affiliation |
Government Dental College, Kottayam, Kerala. |
| Address |
Room No 103, Department of OMFS, Government Dental College, Kottayam, Kerala.
Kottayam
KERALA
686008
India |
| Phone |
8778919585 |
| Fax |
|
| Email |
rangithsr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rangith |
| Address |
Room No 103, Department of OMFS, Government Dental College, Kottayam, Kerala. Pincode : 686008 |
| 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 |
| Dr Rangith |
Government Dental College, Kottayam, Kerala. |
Room No 103, Department of OMFS, Government Dental College, Kottayam, Kerala.
Kottayam
KERALA |
8778919585
rangithsr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals indicated for extraction impacted mesioangular mandibular teeth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Platelet Rich Plasma |
Placed in the extraction socket of impacted mandibular third molar immediately post surgery. Frequency : 1 time . Total duration : 6 months post surgery. |
| Intervention |
Synthetic graft with Platelet Rich Plasma |
Synthetic graft and Platelet rich plasma are mixed and placed in the extraction socket of impacted mandibular third molar immediately post surgery. Frequency : 1 time. Total duration : 6 months post surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring the extraction of impacted bilateral mesioangular mandibular third molars.
Adequate bone quality at the extraction site for grafting.
Willingness to participate in the study and adhere to follow up visits.
Medically healthy individuals with no contraindications to surgery. |
|
| ExclusionCriteria |
| Details |
Patients with systemic health issues(eg: uncontrolled diabetes, bleeding disorders).
History of radiation therapy in the head and neck region.
Active infections at the extraction site.
Smokers or patients with poor oral hygiene.
Pregnant or breast feeding women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bone regeneration evaluated by radiographic analysis(OPG) at follow-up at 6 months to assess bone density and new bone formation. |
6 months post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Soft tissue healing |
1 week post surgery |
| Pain and Swelling |
1 week and 1 month post surgery |
| Healing time |
1 week and 1 month post surgery |
| Complications like infection, graft failure, or delayed healing |
1 week and 1 month post surgery |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="0"
Months="10"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- 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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [rangithsr@gmail.com].
- For how long will this data be available start date provided 01-03-2026 and end date provided 31-05-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This
study is a randomized single blind split mouth study comparing the effectiveness of Platelet Rich Plasma alone and synthetic
bone grafts combined with Platelet Rich Plasma in 34 patients requiring
the extraction of impacted bilateral mesioangular mandibular third
molars that will be conducted in Government Dental College Kottayam. The
primary outcome measure will be bone regeneration evaluated by
radiographic analysis at 6 months. The secondary outcomes will be
postoperative mouth opening swelling wound healing and pain evaluated at
1 week and 1 month |