drugset / Trial / NCT07848035
Injectable Platelet-Rich Fibrin and Microneedling With or Without Vitamin C for Gingival Phenotype Augmentation.
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2026-10
- Primary completion
- 2027-07
- Completion
- 2027-07
Publications
- Background Chetana, Sidharthan S, Dharmarajan G, Iyer S, Poulose M, Guruprasad M, Chordia D. Evaluation of microneedling with and without injectable-platelet rich fibrin for gingival augmentation in thin gingival phenotype-A randomized clinical trial. J Oral Biol Craniofac Res. 2024 Jan-Feb;14(1):49-54. doi: 10.1016/j.jobcr.2023.10.008. Epub 2023 Dec 15.
- Background Idris MI, Burhan AS, Hajeer MY, Sultan K, Nawaya FR. Efficacy of the injectable platelet-rich fibrin (i-PRF) in gingival phenotype modification: a systematic review and meta-analysis of randomized controlled trials. BMC Oral Health. 2024 Nov 1;24(1):1331. doi: 10.1186/s12903-024-05109-5.
- Background Sherif MA, Anter E, Graetz C, El-Sayed KF. Injectable platelet-rich fibrin with vitamin C as an adjunct to non-surgical periodontal therapy in the treatment of stage-II periodontitis: a randomized controlled clinical trial. BMC Oral Health. 2025 May 23;25(1):772. doi: 10.1186/s12903-025-06115-x.
- Background Ahuja A, Minz RSM, Ahuja V, Mishra A, Kumari S. Evaluation of Regenerative Potential of Locally Delivered Vitamin C along with Microneedling in the Treatment of Deficient Interdental Papilla: A Clinical Study. J Contemp Dent Pract. 2022 May 1;23(5):503-507.
- Background Adhikary R, Mohan P, Wadhawan A, Tyagi P. Gingival Augmentation in the Thin Phenotype Using Injectable Platelet-Rich Fibrin and Microneedling. Cureus. 2023 Jun 14;15(6):e40435. doi: 10.7759/cureus.40435. eCollection 2023 Jun.
- Background Ozsagir ZB, Saglam E, Sen Yilmaz B, Choukroun J, Tunali M. Injectable platelet-rich fibrin and microneedling for gingival augmentation in thin periodontal phenotype: A randomized controlled clinical trial. J Clin Periodontol. 2020 Apr;47(4):489-499. doi: 10.1111/jcpe.13247. Epub 2020 Feb 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vitamin C | Other / unclassified | — | Other |
| Background | injectable platelet-rich fibrin (i-PRF) | Unknown | — | Other |
Indications
No indication recorded.