Adding Effect of Cross-linked Hyaluronic Acid to Microneedling After Coronally Advanced Flap in Isolated RT1 Recession

NCT07520539 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: role of hyaluronic acid
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

In patients with single RT1 recessions and thin gingival phenotype, does adding cross-linked hyaluronic acid by microneedling after CAF surgery produce greater gingival thickness gain and higher probability of complete root coverage at 6 months than microneedling alone?

Conditions

Single RT1 Gingival Recession With no Loss of Interproximal Attachment

Outcome Measures

Primary Outcomes (1)

• Gingival thickness

  using a No.15 endodontic spreader with a silicon stopper placed 2 mm apical to the gingival margin at the mid-buccal aspect; depth of penetration measured with a ruler to the nearest 0.5 mm.

  6-months post surgery

Secondary Outcomes (10)

• Complete Root Coverage (CRC)

  6 months post surgery

• Percentage of Root Coverage (%)

  6 months post surgery

• Keratinized Tissue Width (KTW)

  6 months post surgery

• Recession Depth (RD)

  6 months post surgery

• Recession Width (RW)

  6 months post surgery

Study Arms (2)

test group

EXPERIMENTAL

Microneedling sessions will be performed 1 month after the CAF procedure to ensure initial flap healing. The micro-needling technique will be performed under local anesthesia, by using Dr. Pen Ultima M8 MN pen (Dr. Pen; Phoenix, AZ, USA) using 16-Pins gauge with a diameter of 0.18 mm adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. The MN needles are vertically inserted into the keratinized tissue reaching the bone, for 30-40 s per tooth using an intermittent motion along the keratinized tissue. Then, cross-linked hyaluronic acid will be injected in a volume of 0.2mm of a 20 mg/ml concentration with particle size 400 μm. HA injection will be administrated until blanching of gingiva is evident. To ascertain that the HA is distributed evenly the region will be gently massaged for 2 to 3 min with a sterile gauze soaked in saline. This Microneedling technique with HA injection will be repeated four times at 10-day intervals.

Combination Product: cross-linked hyaluronic acid

control group

ACTIVE COMPARATOR

Microneedling sessions will be performed 1 month after CAF procedure to ensure initial flap healing. The micro-needling technique will be performed under local anesthesia, by using Dr. Pen Ultima M8 MN pen (Dr. Pen; Phoenix, AZ, USA) using 16-Pins gauge with a diameter of 0.18 mm adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. The MN needles are vertically inserted into the keratinized tissue reaching the bone, for 30-40 s per tooth using an intermittent motion along the keratinized tissue. This method will be repeated four times at 10-day intervals.

Device: Microneedling

Interventions

cross-linked hyaluronic acid COMBINATION_PRODUCT

Microneedling sessions will be performed 1 month after the CAF procedure to ensure initial flap healing. The micro-needling technique will be performed under local anesthesia, by using Dr. Pen Ultima M8 MN pen (Dr. Pen; Phoenix, AZ, USA) using 16-Pins gauge with a diameter of 0.18 mm adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. The MN needles are vertically inserted into the keratinized tissue reaching the bone, for 30-40 s per tooth using an intermittent motion along the keratinized tissue. Then, cross-linked hyaluronic acid will be injected in a volume of 0.2mm of a 20 mg/ml concentration with particle size 400 μm. HA injection will be administrated until blanching of gingiva is evident. To ascertain that the HA is distributed evenly, the region will be gently massaged for 2 to 3 min with a sterile gauze soaked in saline. This Microneedling technique with HA injection will be repeated four times at 10-day intervals.

test group

Microneedling DEVICE

Microneedling sessions will be performed 1 month after CAF procedure to ensure initial flap healing. The micro-needling technique will be performed under local anesthesia, by using Dr. Pen Ultima M8 MN pen (Dr. Pen; Phoenix, AZ, USA) using 16-Pins gauge with a diameter of 0.18 mm adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. The MN needles are vertically inserted into the keratinized tissue reaching the bone, for 30-40 s per tooth using an intermittent motion along the keratinized tissue. This method will be repeated four times at 10-day intervals.

control group

Eligibility Criteria

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

You may qualify if:

• Adult (≥18 years) with Single RT1 gingival recession in esthetic zone.
• Thin gingival biotype (≤ 1mm).
• Systemically healthy patients.
• Non- smoker patients.
• Full-mouth bleeding on probing (BOP) and plaque indices (PI) scores ≤15%.
• Willingness to comply with follow up and maintenance.

You may not qualify if:

• RT2 or RT3 recessions or multiple adjacent recessions.
• Previous mucogingival surgery at the test site.
• Use of medications causing gingival enlargement.
• Uncontrolled systemic disease.
• Pregnancy or lactation.
• Current smokers.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 9, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04