Topical Hyaluronic Acid Adjunctive Effects on Healing After Free Gingival Grafting in Smokers and Non-Smokers

NCT07143760 | Completed FDA Device

• 1 other identifier: 2023/18
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of the healing of free gingival grafts applied to smokers and non-smokers and evaluation of the effect of hyaluronic acid gel on healing of the donor site.

Conditions

Recession, Gingival; Tissue Grafts

Keywords

free gingival graft; hyaluronic acid; smoking; visual analogue scale

Outcome Measures

Primary Outcomes (1)

• Healing outcome of the palatal donor site

  Clinical assessment of epithelialisation using standardised scoring. Assessment of the palatal donor site was undertaken through standardised measurements of graft epithelialisation at predefined intervals using a Williams periodontal probe.

  Baseline, Day 7 , Day 14, 1. Month, 3. Months

Secondary Outcomes (1)

• Visual Analogue Scale pain scores

  Days 3, 7, 10, and 14 postoperatively

Study Arms (4)

Non-smokers who did not use Hyaluronic acid gel

This group consist subjects with Non-smokers who did not use Hyaluronic acid gel

Non-smokers who used Hyaluronic acid gel

This group consist subjects with Non-smokers who used Hyaluronic acid gel

Device: Gengigel

Smokers who did not use Hyaluronic acid gel

This group consist subjects with Smokers who did not use Hyaluronic acid gel

Smokers who used Hyaluronic acid gel

This group consist subjects with Smokers who used Hyaluronic acid gel

Device: Gengigel

Interventions

Gengigel DEVICE

Free gingival graft (FGG) surgery leaves an open wound at the palatal donor site, which heals by secondary intention and can cause patient discomfort. Various adjunctive materials, such as stents, collagen sponges, platelet-rich fibrin, and hyaluronic acid (HA), have been explored to improve healing. HA is a naturally occurring glycosaminoglycan with hydrating, anti-inflammatory, and pro-regenerative properties that support fibroblast and keratinocyte activity and promote angiogenesis. These qualities make HA a promising adjunct for enhancing wound healing in periodontal surgery. However, few studies have assessed its clinical impact on palatal donor site healing after FGG, and in existing studies HA was applied only once by the operator rather than used consistently by patients. This study evaluates daily, patient-applied HA gel to address this gap and compare outcomes in smokers and non-smokers.

Non-smokers who used Hyaluronic acid gel; Smokers who used Hyaluronic acid gel

Eligibility Criteria

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

Study Population

After screening archived patient records from the Istanbul University, Dentistry Faculty, Department of Periodontology archive, a total of 80 patients who had undergone FGG surgery between January 2018 and November 2022 were deemed eligible and included in the study.

You may not qualify if:

• Subjects who do not meet these conditions will not be included in the study.

Sponsors & Collaborators

• Istanbul University: lead
• Ricerfarma S.r.l: collaborator

Study Sites (1)

Istanbul University, Dentistry Faculty, Department of Periodontology

Istanbul, 34116, Turkey (Türkiye)

Location

Related Publications (5)

• Yildirim S, Ozener HO, Dogan B, Kuru B. Effect of topically applied hyaluronic acid on pain and palatal epithelial wound healing: An examiner-masked, randomized, controlled clinical trial. J Periodontol. 2018 Jan;89(1):36-45. doi: 10.1902/jop.2017.170105.

  PMID: 28914592 BACKGROUND

• Silva CO, Ribeiro Edel P, Sallum AW, Tatakis DN. Free gingival grafts: graft shrinkage and donor-site healing in smokers and non-smokers. J Periodontol. 2010 May;81(5):692-701. doi: 10.1902/jop.2010.090381.

  PMID: 20429648 BACKGROUND

• Hatipoglu H, Keceli HG, Guncu GN, Sengun D, Tozum TF. Vertical and horizontal dimensional evaluation of free gingival grafts in the anterior mandible: a case report series. Clin Oral Investig. 2007 Jun;11(2):107-13. doi: 10.1007/s00784-006-0084-x. Epub 2007 Feb 9.

  PMID: 17294229 BACKGROUND

• Cifcibasi E, Karabey V, Koyuncuoglu C, Duzagac E, Genceli E, Kasali K, Cintan S. Clinical evaluation of free gingival graft shrinkage in horizontal and vertical dimensions. J Istanb Univ Fac Dent. 2015 Oct 21;49(3):11-16. doi: 10.17096/jiufd.58759. eCollection 2015.

  PMID: 28955540 BACKGROUND

• Björn, H. (1963). Free Transplantation of Gingiva Propria. Odontol. Rev.

  BACKGROUND

MeSH Terms

Conditions

Gingival Recession; Smoking

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 27, 2025
• Study Start: January 1, 2018
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)