Injectable Platelet-Rich Fibrin and Microneedling With or Without Vitamin C for Gingival Phenotype Augmentation.

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 65 years
• Women only
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Effect of Injectable Platelet-Rich Fibrin Combined With Microneedling, With and Without Local Vitamin C Injection, on Gingival Phenotype Augmentation: A Randomized Split-Mouth Controlled Clinical Trial.

Conditions

Thin Gingival Phenotype

Being tested

Microneedling, Injectable Platelet-Rich Fibrin (i-PRF), Vitamin C, Normal Saline Placebo

Keywords

Gingival phenotype, Gingival thickness, Keratinized tissue width, Gingival augmentation, Injectable platelet-rich fibrin, Microneedling, Vitamin C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• MicroneedlingProcedure or surgery

  Microneedling will be performed on both sides of the mandibular anterior region using a Derma Pen M8 with an 18-needle cartridge at a depth of 1 mm and a speed of 700 cycles per minute. Vertical stamping will be applied for approximately 30-40 seconds per tooth until pinpoint bleeding is achieved. The procedure will be performed at baseline and repeated after 4 weeks.

• Injectable Platelet-Rich Fibrin (i-PRF)Biological

  Approximately 10 mL of venous blood will be collected in a sterile tube without anticoagulant and centrifuged at 700 revolution per minute for 3 minutes. The upper liquid platelet- and leukocyte-rich fraction will be aspirated and injected submucosally into both sides of the mandibular anterior region, approximately 3 mm apical to the free gingival margin. The procedure will be repeated after 4 weeks.

• Vitamin CDrug

  Vitamin C will be administered locally on the test side as a separate sequential injection in close proximity to the i-PRF injection site within the same treatment zone. The injection will be given after microneedling and i-PRF administration and repeated after 4 weeks. The final concentration and injection volume will follow the finalized study protocol.

• Normal Saline PlaceboDrug

  Normal saline will be administered locally on the control side as a placebo, using the same route and timing as the vitamin C injection. It will be given as a separate sequential injection in close proximity to the i-PRF injection site within the same treatment zone and repeated after 4 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Between-Side Difference in Change in Gingival Thickness From Baseline to 3 Months

   Gingival thickness will be measured at the mid-facial aspect of the mandibular anterior teeth, 3 mm apical to the free gingival margin, using direct transgingival measurement with a standardized endodontic instrument and digital caliper. For each participant, the change in gingival thickness from baseline to 3 months will be calculated separately for the vitamin C side and the placebo side. The paired between-side difference in change will then be compared.

   Measured: Baseline and 3 months after the second treatment session

2. Between-Side Difference in Change in Keratinized Tissue Width From Baseline to 3 Months

   Keratinized tissue width will be measured at the mid-facial aspect of the mandibular anterior teeth as the distance from the free gingival margin to the mucogingival junction using a University of North Carolina 15-mm (UNC-15) periodontal probe. For each participant, the change in keratinized tissue width from baseline to 3 months will be calculated separately for the vitamin C side and the placebo side. The paired between-side difference in change will then be compared.

   Measured: Baseline and 3 months after the second treatment session

3. Between-Side Difference in Change in Gingival Thickness From Baseline to 6 Months

   Gingival thickness will be measured at the mid-facial aspect of the mandibular anterior teeth, 3 mm apical to the free gingival margin, using direct transgingival measurement with a standardized endodontic instrument and digital caliper. For each participant, the change in gingival thickness from baseline to 6 months will be calculated separately for the vitamin C side and the placebo side. The paired between-side difference in change will then be compared.

   Measured: Baseline and 6 months after the second treatment session

4. Between-Side Difference in Change in Keratinized Tissue Width From Baseline to 6 Months

   Keratinized tissue width will be measured at the mid-facial aspect of the mandibular anterior teeth as the distance from the free gingival margin to the mucogingival junction using a University of North Carolina 15-mm (UNC-15) periodontal probe. For each participant, the change in keratinized tissue width from baseline to 6 months will be calculated separately for the vitamin C side and the placebo side. The paired between-side difference in change will then be compared.

   Measured: Baseline and 6 months after the second treatment session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted29 Sep 2026
2. Study startOct 2026 (estimated)
3. Primary completionJul 2027 (estimated)
4. Study completionJul 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (6)Papers the sponsor has linked to this study.
• Other trials for Thin Gingival PhenotypeStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.