| CTRI Number |
CTRI/2026/02/103342 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
PRF vs Natural Healing in Preserving Jawbone After Tooth Extraction |
|
Scientific Title of Study
|
Ridge Width Preservation in Mandibular Multirooted Tooth Extraction: PRF vs. Non-PRF
Approaches |
| 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 Mahika Borgave |
| Designation |
Post graduate student |
| Affiliation |
SMBT DENTAL COLLEGE AND HOSPITAL |
| Address |
G 02 ,Department of Periodontology , SMBT Dental College and Hospital , Amrutnagar, Ghulewadi Sangamner Ahmednagar Maharashtra.
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9766909864 |
| Fax |
|
| Email |
mahikaborgave99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purushottam Rakhewar |
| Designation |
head of department and PG guide |
| Affiliation |
SMBT DENTAL COLLEGE AND HOSPITAL |
| Address |
G 02 ,Department of Periodontology , SMBT Dental College and Hospital , Amrutnagar, Ghulewadi Sangamner Ahmednagar Maharashtra.
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9370017343 |
| Fax |
|
| Email |
drpsrakhewar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahika Borgave |
| Designation |
Post graduate student |
| Affiliation |
SMBT DENTAL COLLEGE AND HOSPITAL |
| Address |
G 02 ,Department of Periodontology , SMBT Dental College and Hospital , Amrutnagar, Ghulewadi Sangamner Ahmednagar Maharashtra.
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9766909864 |
| Fax |
|
| Email |
mahikaborgave99@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT DENTAL COLLEGE AND HOSPITAL,SANGAMNER |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [none] |
|
|
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 Mahika Borgave |
SMBT dental college and hospital , sangamner |
G 02 ,Department of Periodontology , SMBT Dental College and Hospital , Amrutnagar, Ghulewadi Sangamner Ahmednagar Maharashtra.
Ahmadnagar
MAHARASHTRA |
09766909864
mahikaborgave99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Committee on ethics , SMBT Dental college , Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
blood clot |
After tooth extraction, a blood clot forms within the socket and acts as a natural scaffold for healing. It protects the underlying bone, supports granulation tissue formation, and initiates new bone and soft tissue regeneration in 6 months. Loss of the clot may lead to delayed healing or dry socket. |
| Intervention |
prf plug |
A PRF plug is an autologous fibrin matrix obtained from the patient’s blood, rich in platelets and growth factors. It is placed in extraction sockets to enhance soft tissue healing. it promotes bone regeneration, reduce postoperative pain, and minimize ridge resorption in 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients requiring extraction of mandibular multirooted teeth due to non-restorable conditions.
2.Systemically healthy individuals aged 18–50 years.
3.Patients with no active infections or systemic diseases that could affect healing.
4.Adequate pre-extraction alveolar bone volume confirmed radiographically.
|
|
| ExclusionCriteria |
| Details |
1.Smokers or individuals with habits impacting oral health.
2.Patients with systemic conditions such as diabetes or osteoporosis.
3.History of recent bisphosphonate therapy or radiation therapy in the head and neck region.
4.Pregnant or lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Ridge Width
2 Ridge Height
3 Healing Outcomes
4 Plaque and Gingival Indices
5 Pocket Probing Depth
6 Cone Beam Computed Tomography
7 Intraoral Periapical Radiographs
|
baseline , 3months , 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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 4 |
|
Date of First Enrollment (India)
|
18/03/2026 |
| 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="0"
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 - 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 - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mahikaborgave99@gmail.com].
- For how long will this data be available start date provided 06-10-2026 and end date provided 06-01-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This clinical study evaluated the effectiveness of Platelet-Rich Fibrin (PRF) in preserving ridge width and enhancing healing following extraction of mandibular multirooted teeth. Tooth extraction often leads to alveolar ridge resorption, compromising future prosthetic or implant rehabilitation. PRF, an autologous platelet concentrate rich in growth factors, has been proposed as a biological aid to improve post-extraction healing outcomes. Fourteen systemically healthy patients requiring mandibular multirooted tooth extraction were divided into two groups: PRF-treated sockets (test group) and sockets allowed to heal naturally without PRF (control group). Clinical and radiographic parameters—including ridge width, ridge height, healing score, bone fill percentage, plaque index, and pocket probing depth—were evaluated at baseline, 3 months, and 6 months using clinical measurements, CBCT, and IOPA radiographs. Results demonstrated that PRF-treated sockets showed significantly better preservation of ridge width and height, faster and more complete soft tissue healing, and higher bone fill percentages compared to the non-PRF group. Radiographic findings confirmed increased bone density and reduced resorption in PRF-treated sites. Additionally, improved periodontal health was observed in the PRF group. The study concludes that PRF is an effective, cost-efficient, and biocompatible adjunct for extraction socket management, particularly in mandibular multirooted teeth, and plays a valuable role in ridge preservation and preparation for future rehabilitation. |