Skip to main content
OpenTrials
Completed

NCT Number: NCT07437885

Effects of the Adjunctive Use of Hyaluronic Acid-based Gel With Coranally Advanced Flap in the Gingival Recession

The study aimed to evaluate the effect of Hyaluronic Acid-based gel use in addition to the coronally advanced flap (CAF) technique in type 1 gingival recession (RT1) on postoperative morbidity, clinical parameters, and patient satisfaction, analyzed at baseline and 6 months.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Figen Öngöz Dede

Ordu, 52100, Turkey (Türkiye)

About this study

The aim of this study is to evaluate the effect of HA use in addition to the coronally advanced flap (CAF) technique in type 1 gingival recession (RT1) on postoperative morbidity, clinical parameters, and patient satisfaction, analyzed at baseline and 6 months.

This split-mouth study included 20 patients (9 males, 11 females) with a mean age of 42.10±9.46 years who were diagnosed with bilateral RT1 gingival recession in the maxilla. The right and left defect areas of the 20 patients were randomly assigned to two groups. The control group received CAF (n=20), and the test group received CAF+HA (n=20). Pre-treatment plaque index (PI), gingival index (GI), probing pocket depth (PPD), clinical attachment level (CAL), vertical recession depth (VRD), horizontal recession width (HRW), gingival thickness (GT), attached gingival (AG), and keratinized gingival width (KGW) were recorded. Additionally, a satisfaction analysis was conducted, including patient-based comfort (PBC), aesthetic (PEA), and sensitivity (PHS) scores. During the operation, a 0.8% HA gel was applied to the defect areas in the test group, in addition to CAF, while saline was applied to the control group, also in addition to CAF. Pain, bleeding, and edema scores, as well as the amount of painkillers, were recorded during the 9-day postoperative period. Clinical parameter measurements and patient satisfaction analyses were repeated 6 months after surgical treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Double-sided type 1 gingival recession
  • No inflammation

Exclusion criteria

  • active periodontal disease
  • smokers
  • pregnant and breastfeeding women
  • individuals with unilateral GR

Treatment and study plan

Hyaluronic acid

Drug

0.8% hyaluronic acid gel (Gengigel Oral Forte Gel, Ricefarma, Milan, Italy)

Steril saline solution

Other

Mix 8 teaspoons of salt into 4 L of distilled water

Primary outcomes

  1. Complete root coverage

    Time frame: 6 months postsurgery

    for evaluating rate of complete root coverage

  2. Mean root coverage

    Time frame: 6 months postsurgery

    for evaluating rate of mean root coverage

Secondary outcomes

  1. Plaque Index

    Time frame: Baseline

    to assess plaque accumulation

  2. Plaque Index

    Time frame: 6 months post surgery

    to assess plaque accumulation

  3. Gingival Index

    Time frame: Baseline

    for evaluating gingival inflammation

  4. Gingival index

    Time frame: 6 montsh post surgery

    for evaluating gingival inflammation

  5. Probing pocket depth

    Time frame: Baseline

    for measuring disease severity

  6. Probing pocket depth

    Time frame: 6 months post surgery

    for measuring disease severity

  7. Clinical attachment level

    Time frame: Baseline

    Clinical attachment level (CAL) is calculated by adding or subtracting probing depth (PD) and gingival recession (GR). The formula is CAL = PD + GR. CAL is measured in millimeters.

  8. Clinical attachment level

    Time frame: 6 months post surgery

    Clinical attachment level (CAL) is calculated by adding or subtracting probing depth (PD) and gingival recession (GR). The formula is CAL = PD + GR. CAL is measured in millimeters.

  9. Vertical recession depth

    Time frame: Baseline

    for evaluating gingival recession depth

  10. Vertical recession depth

    Time frame: 6 months postsurgery

    for evaluating gingival recession depth

  11. Horizontal gingival recession

    Time frame: Baseline

    for evaluating gingival recession depth

  12. Horizontal gingival recession

    Time frame: 6 months postsurgery

    for evaluating gingival recession depth

  13. Attached gingival width

    Time frame: Baseline

    for evaluating attached gingival width

  14. Attached gingival width

    Time frame: 6 months postsurgery

    for evaluating attached gingival width

  15. Keratinized gingival width

    Time frame: Baseline

    for evaluating keratinized gingival width

  16. Keratinized gingival width

    Time frame: 6 months postsurgery

    for evaluating keratinized gingival width

  17. Gingival thickness

    Time frame: Baseline

    for evaluating gingival thickness

  18. Gingival thickness

    Time frame: 6 months postsurgery

    for evaluating gingival thickness

  19. Patient comfort score

    Time frame: Baseline

    Patient satisfaction was assessed using a visual analog scale (VAS). "unbearable discomfort (score 0)" to "no discomfort (score 10)".

  20. Patient comfort score

    Time frame: 6 months postsurgery

    Patient satisfaction was assessed using a visual analog scale (VAS). "unbearable discomfort (score 0)" to "no discomfort (score 10)".

  21. Patient aesthetic score

    Time frame: Baseline

    Poor-unexpected aesthetics (score 0) → beautiful-perfect aesthetics (score 10) using VAS scale

  22. Patient aesthetic score

    Time frame: 6 months post surgery

    Poor-unexpected aesthetics (score 0) → beautiful-perfect aesthetics (score 10) using VAS scale

  23. Patient sensitivity score

    Time frame: Baseline

    painless-discomfort no (score 0) → unbearable pain (score 10) using VAS scale

  24. Patient sensitivity score

    Time frame: 6 months postsurgery

    painless-discomfort no (score 0) → unbearable pain (score 10) using VAS scale

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

Clinical Efficacy and Patient Experience of Adjunctive Hyaluronic Acid-based Gel Application With Coronally Advanced Flap in Type 1 Gingival Recession: A Randomized Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2026
Registry last updated
Feb 27, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.