Plasma Rich in Growth Factors (PRGF) for alveolar ridge preservation

ISRCTN	ISRCTN18155743
DOI	https://doi.org/10.1186/ISRCTN18155743
Sponsor	Siksha O Anusandhan University
Funder	Siksha O Anusandhan University

Submission date: 24/08/2026
Registration date: 26/08/2026
Last edited: 02/09/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Tejas Pande
Public, Principal investigator, Scientific

Institute of Dental Sciences, K8, Kalinga Nagar
Bhubaneswar
751003
India

Phone	+91 9938899188
Email	sauravpanda@soa.ac.in

Study information

Primary study design	Interventional
Allocation	Non-randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Sequential
Purpose	Treatment
Participant information sheet	50139_PIS.pdf
Scientific title	Clinical and radiographic evaluation of Plasma Rich in Growth Factors (PRGF) for alveolar ridge preservation in the anterior maxilla
Study objectives	To find the clinical effectiveness of PRGF when compared to spontaneous healing for alveolar ridge preservation in the anterior maxilla.
Ethics approval(s)	Approved 15/11/2024, Institutional Ethical Committee (IEC) Institute of Dental Sciences of Siksha O Anusandhan University (K8, Kalinga Nagar, Bhubaneswar, 751003, India; +91 06742386908; iec.ids@soa.ac.in), ref: IEC-IDS/IDS/SOA/2024/III-19
Health condition(s) or problem(s) studied	Post tooth-extraction healing of alveolar sockets
Intervention	The participants were divided into two groups with 10 sockets per group: Group 1 (PRGF group): Sockets were filled with PRGF clot and then covered with PRGF membrane. Group 2 (SH Group): Sockets were left to heal spontaneously. Preparation of Plasma Rich in Growth Factors (PRGF) Blood was collected in 9 mL vacutainers containing 3.8% sodium citrate (BTI-Endoret® System V Centrifuge, BiotechnologyInstitute, Vitoria, Spain) and then the tubes were centrifuged at 580 g for 8 minutes using an Endoret System centrifuge (En-doret® System IV, Biotechnology Institute BTI S.L. Miñano,Álava, Spain). The plasma obtained was then separated into two layers: F1: Platelet-poor Plasma F2: The 2 mL of the plasma column just above the buffy coat F2 layer was used to obtain the clot, as it was the fraction richest in platelets, by ac-tivating it using PRGF activator (10% calcium chloride). F1 layer was similarly activated to obtain the fibrin membrane. Interventional Surgical Procedure: All the procedures were performed under sterile conditions. 2% lignocaine with 1:100,000 epinephrine was administered to the patients to obtain adequate anesthesia. Atraumatic extraction was carried out in both groups using periotomes and elevators to reduce trauma to the surrounding alveolar bone, buccal cortical plate and soft tissues. After tooth removal, the socket was debrided meticulously to eliminate granulation tissue and debris. In the PRGF group, after tooth extraction, PRGF clot was packed in the socket and then the socket was covered with a PRGF membrane. In the spontaneous healing group, the extraction socket was left to heal without the placement of any biomaterial. A cross-mattress suture was placed using 4-0 non-resorbable silk across the socket to sta-bilize the clot and facilitate healing. Sutures were removed after 7 days.
Intervention type	Supplement
Primary outcome measure(s)	Alveolar ridge dimensions measured using radiography by Cone Beam Computed Tomography (CBCT) in mm at baseline and 3 months
Key secondary outcome measure(s)	Radiographic bone density measured using CBCT derived as Hounsfield Units at Baseline and 3 months Percentage of connective tissue and new bone formation measured using a histomorphometric evaluation at 3 months Early soft tissue wound healing and flap closure measured using the Early Healing Index (EHI) at days 1, 3 and 7 Post operative pain measured using a Visual Analog Scale (VAS) in mm at days 1, 3 and 7 Soft tissue healing score measured using Index number at 1 week, 1 month and 3 month
Completion date	31/03/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	20
Total final enrolment	20
Key inclusion criteria	1. Male and female patients aged ≥18 years 2. An indication for uncomplicated tooth extraction in the anterior maxilla
Key exclusion criteria	1. Presence of dehiscence 2. Loss of socket walls 3. Significant swelling or acute infection at the extraction site 4. A history of radiotherapy, chemotherapy, immunosuppressive therapy, systemic corticosteroid use or any anticoagulant therapy within the past 30 days 5. Regular use of NSAIDs 6. Uncontrolled diabetes 7. Presence of malignant tumours 8. Pregnant or lactating women, or those planning pregnancy during the study period
Date of first enrolment	15/11/2024
Date of final enrolment	31/10/2025

Locations

Countries of recruitment

India

Study participating centre

Institute of Dental Sciences, Siksha O Anusandhan University

Bhubaneswar
India

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from Dr Saurav Panda, sauravpanda@soa.ac.in, drsaurav87@gmail.com

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet			26/08/2026	No	Yes

Additional files

50139_PIS.pdf: Participant information sheet

Editorial Notes

02/09/2026: The date of first enrolment was changed from 15/09/2024 to 15/11/2024.
26/08/2026: Study’s existence confirmed by the Institutional Ethical Committee (IEC), Institute of Dental Sciences of Siksha O Anusandhan University, India.