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COMPLETED
NCT07879534
NA

Injectable Platelet-Rich Fibrin Versus Hyaluronic Acid for Thin Gingival Phenotype

Sponsor: University of Yaounde 1

View on ClinicalTrials.gov

Summary

Thin gingival phenotype may increase susceptibility to soft-tissue complications in the presence of local anatomical or mechanical risk factors. Minimally invasive injectable approaches such as injectable platelet-rich fibrin (i-PRF) and hyaluronic acid (HA) have been proposed to increase gingival thickness. This randomized split-mouth clinical trial compared repeated i-PRF and non-cross-linked HA injections in adults with a thin mandibular anterior gingival phenotype. Each participant received i-PRF on one mandibular anterior hemi-arch and HA on the contralateral hemi-arch. The primary objective was to compare changes in gingival thickness and keratinized tissue width between the two interventions. Periodontal clinical parameters and injection-related morbidity were assessed as secondary outcomes.

Official title: Comparative Efficacy of Injectable Platelet-Rich Fibrin Versus Hyaluronic Acid for Gingival Phenotype Modification: A Randomized Split-Mouth Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

11

Start Date

2024-06-10

Completion Date

2024-08-31

Last Updated

2026-10-19

Healthy Volunteers

No

Interventions

BIOLOGICAL

Injectable Platelet Rich Fibrin

At each session, 10 mL of venous blood was collected into an anticoagulant-free tube and immediately centrifuged using a DUO Quattro centrifuge (Process for PRF, Nice, France) at 700 rpm (approximately 60 x g at the maximum rotor radius). Centrifugation was performed for 5 minutes in female participants and 6 minutes in male participants, according to the protocol used in the study. The upper orange liquid fraction was collected. Using 1-mL insulin syringes with integrated 30-gauge needles, i-PRF was slowly injected at two points per treated tooth: approximately 3 mm apical to the free gingival margin and apical to the mucogingival junction. Injection continued until visible tissue blanching; no predetermined fixed volume was administered per injection point or tooth. Three sessions were performed on Day 0, Day 7, and Day 14.

DRUG

Hyaluronic Acid

Non-cross-linked sodium hyaluronate (ADANT, 10 mg/mL; 2.5-mL prefilled syringe) was used. Using 1-mL insulin syringes with integrated 30-gauge needles, hyaluronic acid was slowly injected at two points per treated tooth: approximately 3 mm apical to the free gingival margin and apical to the mucogingival junction. Injection continued until visible tissue blanching; no predetermined fixed volume was administered per injection point or tooth. Three sessions were performed on Day 0, Day 7, and Day 14.

Locations (1)

Faculty of Medicine and Biomedical Sciences, University of Yaounde I

Yaoundé, Cameroon