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Injectable Platelet-Rich Fibrin and Microneedling With or Without Vitamin C for Gingival Phenotype Augmentation.
Sponsor: University of Science and Technology, Yemen
Summary
This randomized split-mouth clinical trial will evaluate whether adding locally injected vitamin C to injectable platelet-rich fibrin (i-PRF) and microneedling improves gingival tissue thickness and keratinized tissue width in women with a thin gingival phenotype in the lower front teeth region. Each participant will receive i-PRF and microneedling on both sides of the lower anterior region. One side will additionally receive vitamin C, while the opposite side will receive normal saline as a placebo. The treatment will be repeated after 4 weeks. Gingival measurements will be taken at baseline, 3 months, and 6 months after the second treatment session. Patient satisfaction will also be assessed during follow-up.
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.
Key Details
Gender
FEMALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
27
Start Date
2026-10
Completion Date
2027-07
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
Microneedling
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)
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 C
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 Placebo
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.
Locations (1)
University of Science and Technology, Aden
Aden, Yemen