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Not yet recruiting NCT07520539

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

Phase I / Phase II Interventional Single RT1 Gingival Recession With no Loss of Interproximal Attachment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cross-linked hyaluronic acid, Microneedling.
Who it may be relevant to
Registry conditions: Single RT1 Gingival Recession With no Loss of Interproximal Attachment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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?

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.

Interventions

  • 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
  • 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 kera

Primary outcome measures

  • Gingival thickness [Time frame: 6-months post surgery]
Secondary outcome measures (10)
  • Complete Root Coverage (CRC) [Time frame: 6 months post surgery]
  • Percentage of Root Coverage (%) [Time frame: 6 months post surgery]
  • Keratinized Tissue Width (KTW) [Time frame: 6 months post surgery]
  • Recession Depth (RD) [Time frame: 6 months post surgery]
  • Recession Width (RW) [Time frame: 6 months post surgery]
  • Recession Reduction (Rec-Red) [Time frame: 6 months post surgery]
  • Clinical Attachment Level (CAL) [Time frame: 6 months post surgery]
  • Probing Depth (PD) [Time frame: 6 months post surgery]
  • Root Coverage Esthetic Score (RES) [Time frame: 6 months post surgery]
  • Condition-specific Health-related Quality-of-life [Time frame: 6 months post surgery]

Eligibility criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07520539 · role of hyaluronic acid

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗