i-PRF and Microneedling With or Without Vitamin C for Gingival Phenotype Augmentation.

NCT07848035 | Not Yet Recruiting

• 1 other identifier: UST-ETH-2026-0021
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thin Gingival Phenotype

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline and 3 months after the second treatment session

• 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 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.

  Baseline and 3 months after the second treatment session

• 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.

  Baseline and 6 months after the second treatment session

• 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 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.

  Baseline and 6 months after the second treatment session

Secondary Outcomes (8)

• Within-Side Change in Gingival Thickness From Baseline to 3 Months

  Baseline and 3 months after the second treatment session

• Within-Side Change in Keratinized Tissue Width From Baseline to 3 Months

  Baseline and 3 months after the second treatment session

• Within-Side Change in Gingival Thickness From Baseline to 6 Months

  Baseline and 6 months after the second treatment session

• Within-Side Change in Keratinized Tissue Width From Baseline to 6 Months

  Baseline and 6 months after the second treatment session

• Stability of Gingival Thickness From 3 to 6 Months

  3 and 6 months after the second treatment session

Study Arms (2)

Test Side: i-PRF + Microneedling + Vitamin C

EXPERIMENTAL

One randomly assigned side of the mandibular anterior region will receive microneedling followed by injectable platelet-rich fibrin (i-PRF) and a separate sequential local vitamin C injection. The intervention will be repeated after 4 weeks.

Procedure: Microneedling; Biological: Injectable Platelet-Rich Fibrin (i-PRF); Drug: Vitamin C

Control Side: i-PRF + Microneedling + Placebo

PLACEBO COMPARATOR

The contralateral side of the mandibular anterior region will receive microneedling followed by injectable platelet-rich fibrin (i-PRF) and a separate sequential normal saline injection as placebo. The intervention will be repeated after 4 weeks.

Procedure: Microneedling; Biological: Injectable Platelet-Rich Fibrin (i-PRF); Drug: Normal Saline Placebo

Interventions

Microneedling PROCEDURE

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/min. 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.

Control Side: i-PRF + Microneedling + Placebo; Test Side: i-PRF + Microneedling + Vitamin C

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 rpm 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.

Control Side: i-PRF + Microneedling + Placebo; Test Side: i-PRF + Microneedling + Vitamin C

Vitamin C DRUG

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.

Test Side: i-PRF + Microneedling + Vitamin C

Normal Saline Placebo DRUG

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.

Control Side: i-PRF + Microneedling + Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy female participants.
• Age 18 to 65 years.
• Thin gingival phenotype (\<1.5 mm).
• No known blood disorders.
• Good oral hygiene.

You may not qualify if:

• Pregnancy.
• Use of medications known to cause gingival enlargement.
• History of trauma from occlusion or bruxism.
• Previous soft-tissue grafting or periodontal soft-tissue surgery at the study sites.
• Heavy smoking (\>10 cigarettes per day).
• Known allergy or hypersensitivity to vitamin C.
• Use of vitamin C supplementation within the previous 2 months.

Sponsors & Collaborators

• University of Science and Technology, Yemen: lead

Study Sites (1)

University of Science and Technology, Aden

Aden, Governorate Number One, Yemen

Location

Related Publications (6)

• 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.

  PMID: 38188907 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.

  PMID: 39487452 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.

  PMID: 40410805 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.

  PMID: 35986457 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.

  PMID: 37456469 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.

  PMID: 31912532 BACKGROUND

MeSH Terms

Interventions

Percutaneous Collagen Induction; proliferation regulatory factors, human urine; Ascorbic Acid

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Waddah A Al-Hajj, PhD

  University of Science and Technology, Aden, Yemen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa M Al-Thwabi, BDS

CONTACT

+967773208081; althwabialaa9@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, the treating operator, and the outcome assessor will be blinded to treatment allocation. Vitamin C and normal saline will be provided in coded syringes labeled A and B, and the allocation code will remain concealed during treatment and outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Periodontology and Oral Medicine

Model Details: Randomized split-mouth design in which each participant receives both interventions concurrently on contralateral sides of the mandibular anterior region. One side is randomly assigned to i-PRF plus microneedling and vitamin C, while the opposite side receives i-PRF plus microneedling and normal saline placebo.

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

YE (1)