| CTRI Number |
CTRI/2026/02/103724 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparaision of Conventional Healing versus Platelet Rich Fibrin (PRF) with Bone Graft in Socket Preservation and Effects on Adjacent Periodontal Health –A clinical study |
|
Scientific Title of Study
|
Comparative Evaluation of Conventional Healing versus Platelet Rich Fibrin (PRF) with Bone Graft in Socket Preservation and Effects on Adjacent Periodontal Health – A Randomized Clinical Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Solanki |
| Designation |
Primary Investigator |
| Affiliation |
College of Dental Science and Hospital ,Amargadh , Bhavnagar |
| Address |
At post Vankal, Harihar Bungalow, Limda Chowk ,Near Godavari Petrol pump, Dharampur Road , Vankal , Valsad
College of Dental Science and Hospital, Amargadh, Sihor, Bhavnagar.
Bhavnagar
GUJARAT
396055
India |
| Phone |
8200811963 |
| Fax |
|
| Email |
nehasolanki6499@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kamlesh Singh |
| Designation |
PG Guide and Professor |
| Affiliation |
College of Dental Science and Hospital ,Amargadh , Bhavnagar |
| Address |
Department of Periodontology , College of Dental Science, Amargadh, Bhavnagar – Gujarat
College of Dental Science and Hospital, Amargadh, Sihor, Bhavnagar.
Bhavnagar
GUJARAT
364210
India |
| Phone |
9558817248 |
| Fax |
|
| Email |
drkam14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha Solanki |
| Designation |
Primary Investigator |
| Affiliation |
College of Dental Science and Hospital ,Amargadh , Bhavnagar |
| Address |
At post Vankal, Harihar Bungalow, Limda Chowk ,Near Godavari Petrol pump, Dharampur Road , Vankal , Valsad
College of Dental Science and Hospital, Amargadh, Sihor, Bhavnagar.
Bhavnagar
GUJARAT
396055
India |
| Phone |
8200811963 |
| Fax |
|
| Email |
nehasolanki6499@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Dental Science and Hospital, Amargadh, Sihor, Bhavnagar , Gujarat , India
Pincode : 364210 |
|
|
Primary Sponsor
|
| Name |
Neha Solanki |
| Address |
Department of Periodontology, College of Dental Science and Hospital, Amargadh, Sihor, Bhavnagar, Gujarat, India
Pincode : 364210 |
| 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 |
| Neha Solanki |
College of Dental Science and Hospital Amargadh, Dist. Bhavnagar, Gujarat, India. |
Department of Periodontology ,College of Dental Science and Hospital Amargadh, Dist. Bhavnagar, Gujarat, India.
Bhavnagar
GUJARAT |
8200811963
nehasolanki6499@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (ECR/1189/Inst/GJ/2019/RR-22) College of Dental Science and Hospital (K.J Mehta T.B. Hospital Trust) Amargadh, Dist. Bhavnagar, Gujarat, India. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patient who needs extractions |
| Patients |
(1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bone graft with Platelet Rich Fibrin (PRF) |
Local anesthesia will be administered and atraumatic extraction will be performed.The blood will be collected from the patient and will be placed in the centrifugation machine and rotated at the speed of 700 rpm for 3 minutes to obtain Injectable Platelet Rich Fibrin (i- PRF).This i- PRF formed will be mixed with the bone graft to form Sticky Bone, which will be carried with the help of the bone graft carrier and placed into the socket. Suture will be placed and the surgical site will be covered by periodontal dressing.
|
| Comparator Agent |
Conventional Healing |
Local anesthesia will be administered and atraumatic extraction will be performed. Natural healing will be recorded |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Presence of intact socket walls after extraction.
2. The presence of a minimum of one tooth adjacent to the extraction site.
3. Patient with healthy periodontium adjacent to extraction socket.
4. Patients willing to adhere to follow-up visits.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and Lactating mothers.
2.Patient with any systemic conditions.
3.Presence of acute dentoalveolar infections in the teeth slated for extraction.
4.Smokers / Tobacco chewers.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of conventional healing and platelet-rich fibrin (PRF) combined with bone graft in socket preservation and evaluate their respective impacts on the health and integrity of the adjacent healthy periodontium. |
baseline, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the clinical attachment levels of adjacent teeth post treatment in both conventional healing & socket preservation group.
2.To analyze the periodontal health parameters of teeth adjacent to the extraction sockets in both the groups |
baseline, 6 months |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
26/02/2026 |
| 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="2"
Months="0"
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 study will involve total of 36 patients, aged 20–60 years who will be selected from the Outpatient Department of Periodontology and Department of Oral And Maxillofacial Surgery , Amargadh , Bhavnagar after applying the inclusion and exclusion criteria. The study will be done to determine whether the combination of Platelet rich fibrin (PRF) with bone graft provides superior outcomes on Periodontal Parameters of adjacent teeth compared to conventional healing in socket preservation |