Plasma rich in growth factor in gingival recession coverage

ISRCTN	ISRCTN33741581
DOI	https://doi.org/10.1186/ISRCTN33741581
Sponsor	Siksha O Anusandhan University
Funder	Siksha O Anusandhan University

Submission date: 22/09/2026
Registration date: 25/09/2026
Last edited: 25/09/2026

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

Prof Abhaya Chandra Das
Public

Department of Periodontics, Institute of Dental Sciences, Siksha O Anusandhan University, K8, Kalinga Nagar
Bhubaneswar
751003
India

Phone	+91-9437088379
Email	abhayadas@soa.ac.in

Prof Sourav Panda
Scientific

Department of Periodontics, Institute of Dental Sciences, Siksha O Anusandhan University, K8, Kalinga Nagar
Bhubaneswar
751003
India

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

Dr Mohit Das
Principal investigator

Department of Periodontics, Institute of Dental Sciences, Siksha O Anusandhan University, K8, Kalinga Nagar
Bhubaneswar
751003
India

Phone	7008093223
Email	drabhaya2011@gmail.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Participant information sheet	50328_PIS.pdf
Scientific title	Effect of plasma rich in growth factor with bridge flap in management of Miller’s class I and II gingival recession defects
Study objectives	The purpose of the present clinical study was to compare the clinical efficacy of DLSBF with and without PRGF for the management of gingival recession in the mandibular anterior teeth.
Ethics approval(s)	Approved 22/10/2020, Institutional Ethical Committee-Institute of Medical Sciences (IMS) and SUM Hospital (K8, Kalinga Nagar, Shampur, Bhubaneswar, 751003, India; +916742386281; iec-ims@soa.ac.in), ref: DRI/IMS_SH/SOA/18122/2020
Health condition(s) or problem(s) studied	Surgical management of Miller’s class I and II gingival recession defects
Intervention	Treatment Groups The patients with multiple recession defects were randomly assigned, using block randomization in 1:1 allocation ratio employing computer generated sequence, to be recruited in both groups: 1. Double lateral sliding bridge flap (DLSBF) combined with plasma rich in growth factors (PRGF) group (n = 50 sites in 15 patients) 2. DLSBF alone group (n = 45 sites in 15 patients) PRGF Preparation Venous blood (10 mL) was collected in 3.8% sodium citrate tubes and centrifuged using the PRGF-Endoret® System V (BTI Biotechnology Institute, Vitoria-Gasteiz, Spain) at 580 × g for 8 minutes. Fraction 2 (F2), comprising approximately 2 mL of plasma immediately above the buffy coat, was used clinically and activated with 10% calcium chloride (0.2 mL) immediately before application. Surgical Procedure Following local anesthesia, recession defects in both groups were treated using the DLSBF technique, combining modified Edlan-Mejchar vestibuloplasty with coronally advanced flap principles. A partial-thickness flap was prepared, the papillae were de-epithelialized, and the flap was mobilized to permit tension-free coronal advancement. After root planing, exposed root surfaces were conditioned with 24% EDTA. In the test group, activated PRGF was applied over the conditioned root surface before flap advancement. The flap was stabilized coronally using 6-0 Vicryl sutures, followed by placement of a periodontal dressing. Follow-up and Outcome Assessment Postoperative pain was recorded on Days 1, 3, 7, and 10, while swelling and bleeding were evaluated on Days 3, 7, and 10. Clinical periodontal parameters were reassessed at 3 and 6 months by a blinded examiner using the standardized measurement protocol.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Relative attachment level measured using a UNC 15 periodontal probe from Lower margin of a customized stent up to the base of the gingival sulcus/ pocket (in mm) at baseline, 3 and 6 months Width of keratinized gingiva measured using a UNC 15 periodontal probe from crest of the gingival margin to muco-gingival junctionat (in mm) at baseline, 3 and 6 months
Key secondary outcome measure(s)	Gingival recession depth measured using a UNC 15 periodontal probe from cemento-enamel junction to marginal tissue recession (in mm) at baseline, 3 and 6 months Gingival recession width measured using a UNC 15 periodontal probe estimating mesio-distal dimension of gingival recession at the level of cemento-enamel junction (in mm) at baseline, 3 and 6 months Percentage of root coverage measured using the division of the amount of root covered during healing by the original recession depth, then multiplying by 100 (in percentage), at baseline, 3 and 6 months Gingival thickness measured using an endodontic file with stopper and caliper (in mm) at baseline, 3 and 6 months Patient reported outcomes (swelling, bleeding and pain) measured using a Visual Analogue Scale (VAS) at Day 1 to Day 7 Probing depth measured using a UNC 15 periodontal probe from crest of the gingival margin to gingival sulcus/pocket (in mm) at baseline, 3 and 6 months
Completion date	30/06/2023

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	20 Years
Upper age limit	45 Years
Sex	All
Target sample size at registration	30
Total final enrolment	30
Key inclusion criteria	1. Patients aged 20–45 years 2. Presence of at least two Miller’s Class I or II gingival recession defects in the mandibular anterior sextant 3. Systemically healthy individuals 4. Good oral hygiene with Plaque Index (PI) <1.5 and Oral Hygiene Index (OHI) score <1
Key exclusion criteria	1. Previous periodontal surgery at the study site 2. Antibiotics taken within the last 3 months 3. Patients having cervical restorations or root caries 4. Tobacco smoking or smokeless tobacco use 5. Systemic diseases such as diabetes mellitus or hypertension 6. Medications associated with gingival enlargement 7. Presence of trauma from occlusion
Date of first enrolment	01/11/2020
Date of final enrolment	31/12/2022

Locations

Countries of recruitment

India

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet			22/09/2026	No	Yes

Additional files

50328_PIS.pdf: Participant information sheet

Editorial Notes

22/09/2026: Study’s existence confirmed by the Institutional Ethical Committee-Institute of Medical Sciences (IMS) and SUM Hospital, India.