An interventional study of Injectable Platelet Rich Fibrin and Hyaluronic Acid in Thin Gingival Phenotype, sponsored by University of Yaounde 1. Completed at 1 site in Cameroon. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by University of Yaounde 1 · Not applicable, Interventional, and Treatment
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.
Eleven systemically healthy adults with bilateral thin gingival phenotype in the mandibular anterior region were enrolled. A computer-generated random sequence assigned the left or right mandibular anterior hemi-arch to i-PRF; the contralateral side received non-cross-linked sodium hyaluronate. Allocation was concealed using sealed opaque envelopes. Participants were masked to side allocation; the clinical operator who prepared and administered the interventions and performed outcome measurements was aware of allocation. Both interventions were delivered during the same treatment sessions in a within-participant split-mouth design, with three injection sessions at 7-day intervals (Day 0, Day 7, and Day 14). Gingival thickness and keratinized tissue width were assessed at baseline, 30 days after the third injection, and 2 months after the first follow-up.
University of Yaounde 1 is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
One randomly allocated mandibular anterior hemi-arch received injectable platelet-rich fibrin at three weekly injection sessions.
Biological: Injectable Platelet Rich Fibrin
The contralateral mandibular anterior hemi-arch received non-cross-linked sodium hyaluronate (ADANT) at the same three weekly injection sessions.
Drug: Hyaluronic Acid
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.
Also known as: i-PRF
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.
Also known as: ADANT, Sodium hyaluronate
Gingival Thickness (GT)
Gingival thickness measured in millimeters by standardized transgingival probing and digital caliper.
Time frame: 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.
Time frame: Baseline; 30 days after the third injection; 2 months after the first follow-up
Gingival Inflammation
Gingival inflammation assessed using a 0 to 3 ordinal gingival index.
Time frame: Baseline; 30 days after the third injection; 2 months after the first follow-up
Bleeding on Probing
Bleeding on probing assessed using the study 0 to 5 ordinal bleeding severity scale.
Time frame: Baseline; 30 days after the third injection; 2 months after the first follow-up
Probing Depth Category
Probing depth recorded as an ordinal category: less than 3 mm, 3 to 5 mm, or greater than 5 mm.
Time frame: Baseline; 30 days after the third injection; 2 months after the first follow-up
Injection-Related Pain
Pain assessed on a four-grade verbal scale: absent, mild, moderate, or severe.
Time frame: Day 0; Day 7; Day 14
Injection-Related Edema
Edema assessed on a four-grade verbal scale: absent, mild, moderate, or severe.
Time frame: Day 0; Day 7; Day 14
Postoperative Bleeding
Postoperative bleeding assessed on a four-grade verbal scale: absent, mild, moderate, or severe.
Time frame: Day 0; Day 7; Day 14
Plan to share: Yes — 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.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: Beginning after publication of the study results and available for 5 years.
Access criteria: Data will be shared with qualified researchers upon reasonable request for scientific purposes. Requests should include a brief research proposal and planned analyses and will be reviewed by the corresponding author. Only fully de-identified data will be provided, subject to applicable ethical and institutional requirements.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Yaounde 1