Comparative Efficacy of Injectable Platelet-Rich Fibrin Versus Hyaluronic Acid for Gingival Phenotype Modification: A Randomized Split-Mouth Clinical Trial
Sponsor study identifier
interventional
11
1 country
1
Study Start
June 10, 2024
Actual (reported)Primary Completion
August 31, 2024
Actual (reported)Study Completion
August 31, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 10, 2024
Actual (reported)August 31, 2024
Actual (reported)August 31, 2024
Actual (reported)October 10, 2026
Actual (reported)October 19, 2026
Actual (reported)Gingival Thickness (GT)
Gingival thickness measured in millimeters by standardized transgingival probing and digital caliper.
Baseline; 30 days after the third injection; 2 months after the first follow-up
Keratinized Tissue Width (KTW)
Keratinized tissue width measured in millimeters from the free gingival margin to the mucogingival junction.
Baseline; 30 days after the third injection; 2 months after the first follow-up
Gingival Inflammation
Baseline; 30 days after the third injection; 2 months after the first follow-up
Bleeding on Probing
Baseline; 30 days after the third injection; 2 months after the first follow-up
Probing Depth Category
Baseline; 30 days after the third injection; 2 months after the first follow-up
Injection-Related Pain
Day 0; Day 7; Day 14
Injection-Related Edema
Day 0; Day 7; Day 14
One randomly allocated mandibular anterior hemi-arch received injectable platelet-rich fibrin at three weekly injection sessions.
The contralateral mandibular anterior hemi-arch received non-cross-linked sodium hyaluronate (ADANT) at the same three weekly injection sessions.
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.
Faculty of Medicine and Biomedical Sciences, University of Yaounde I
Yaoundé, Cameroon
Jules Julien Ndjoh
Department of Implantology-Periodontology-Prosthodontics, Faculty of Medicine and Biomedical Sciences, University of Yaounde I
11 participants (actual enrollment reported by the registry).
First Submitted
October 10, 2026
First Posted
October 19, 2026
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
June 10, 2024
Actual (reported)Primary Completion
August 31, 2024
Actual (reported)Study Completion
August 31, 2024
Actual (reported)Last Updated
October 19, 2026
Record last verified: 2026-10
De-identified individual participant data underlying the results reported in this trial, including gingival thickness, keratinized tissue width, periodontal clinical parameters, and injection-related morbidity data, will be available upon reasonable request to the corresponding author.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: