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

Evaluation of Gingival Thickness and Root Coverage Outcomes Following Coronally Advanced Flap Combined With Microneedling With or Without Cross-Linked Hyaluronic Acid in RT1 Recession Defects: A Randomized Clinical Trial

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Single RT1 Gingival Recession With no Loss of Interproximal Attachment
• Intervention / Treatment: Combination product: cross-linked hyaluronic acid; Device: Microneedling

Detailed Description

The aim of this study is to evaluate changes in gingival thickness and root coverage outcomes after coronally advanced flap (CAF) then cross-linked hyaluronic acid injection along with performing microneedling in patients with RT1 single gingival recession with thin gingival phenotype in esthetic region.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

1. Inclusion criteria

   • 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.

2. Exclusion criteria

   • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test group; 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; 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.
Active Comparator: control group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Recession Reduction (Rec-Red)		6 months post surgery
Clinical Attachment Level (CAL)		6 months post surgery
Probing Depth (PD)		6 months post surgery
Root Coverage Esthetic Score (RES)	Root coverage esthetic score (RES) will be measured through direct clinical inspection without magnification and will include five variables: gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), mucogingival junction alignment (MGJ), and gingival color (GC). Zero, 3, or 6 points were used for the evaluation of the position of the gingival margin, whereas a score of 0 or 1 point was used for each of the other variables. Scoring System The maximum achievable esthetic score is 10 points. A score of 0 points is assigned if the final position of the gingival margin is equal to or apical to the initial recession depth, indicating failure of the root coverage procedure, regardless of the other parameters (color, scar formation, MTC, or MGJ). A score of 0 points is also assigned when partial or complete loss of the interproximal papilla (black triangle) occurs following treatment.	6 months post surgery
Condition-specific Health-related Quality-of-life	Condition-specific health-related quality-of-life will be assumed to evaluate the patient satisfaction with the treatment outcome using a questionnaire based on a 5-point Likert scale, where patients will rate their level of satisfaction with the esthetic outcome and overall treatment result. The response options will range from 1 (very dissatisfied) to 5 (very satisfied). The questionnaire will be administered at the 6-month follow-up visit, and the mean satisfaction score will be calculated for each group for statistical comparison.	6 months post surgery

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Punctures; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Percutaneous Collagen Induction
• Other Study ID Numbers: role of hyaluronic acid

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No