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NCT Number: NCT07520539

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

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?

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Key information

Conditions

Single RT1 Gingival Recession With no Loss of Interproximal Attachment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.
  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Gingival thickness

    Time frame: 6-months post surgery

    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.

Secondary outcomes

  1. Complete Root Coverage (CRC)

    Time frame: 6 months post surgery

  2. Percentage of Root Coverage (%)

    Time frame: 6 months post surgery

  3. Keratinized Tissue Width (KTW)

    Time frame: 6 months post surgery

  4. Recession Depth (RD)

    Time frame: 6 months post surgery

  5. Recession Width (RW)

    Time frame: 6 months post surgery

  6. Recession Reduction (Rec-Red)

    Time frame: 6 months post surgery

  7. Clinical Attachment Level (CAL)

    Time frame: 6 months post surgery

  8. Probing Depth (PD)

    Time frame: 6 months post surgery

  9. Root Coverage Esthetic Score (RES)

    Time frame: 6 months post surgery

    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.

  10. Condition-specific Health-related Quality-of-life

    Time frame: 6 months post surgery

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.