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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorUniversity of Science and Technology, Yemen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Systemically healthy female participants.

Age 18 to 65 years.

Thin gingival phenotype (<1.5 mm).

No known blood disorders.

Disqualifiers

Pregnancy.

Use of medications known to cause gingival enlargement.

History of trauma from occlusion or bruxism.

Previous soft-tissue grafting or other periodontal soft-tissue surgery at the study sites.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Microneedling

    Procedure/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/Vaccine

    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

    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.

  • 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.

Treatment groups

27 Participants
are divided into 2 treatment groups
Group A: Test Side: Injectable Platelet-Rich Fibrin + Microneedling + Vitamin CExperimental treatment 3 interventions
Group B: Control Side: Injectable Platelet-Rich Fibrin + Microneedling + PlaceboPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Baseline and 6 months after the second treatment session

Secondary outcomes

1

Within-Side 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. The change in gingival thickness from baseline to 3 months will be evaluated separately within the vitamin C-treated side and the placebo-treated side.

Time frame
Baseline and 3 months after the second treatment session
2

Within-Side 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. The change in keratinized tissue width from baseline to 3 months will be evaluated separately within the vitamin C-treated side and the placebo-treated side.

Time frame
Baseline and 3 months after the second treatment session
3

Within-Side 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. The change in gingival thickness from baseline to 6 months will be evaluated separately within the vitamin C-treated side and the placebo-treated side.

Time frame
Baseline and 6 months after the second treatment session
4

Within-Side 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. The change in keratinized tissue width from baseline to 6 months will be evaluated separately within the vitamin C-treated side and the placebo-treated side.

Time frame
Baseline and 6 months after the second treatment session

Other outcomes

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