Effect of Hyaluronic-acid on the Healing After Free Gingival Graft

NCT03871218 | Completed Phase 2

• 1 other identifier: 19.04.2017 08/14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated the effect of topical hyaluronic acid (HA) application on free gingival graft (FGG) donor and recipient sites during the early wound healing period with laser Doppler flowmetry (LDF) and to investigate the effect of HA application on the dimensional change of the graft.Participants were randomly classified into the test group (TG) and control group (CG). HA was applied to both donor and recipient sites in 20 patients who formed the TG, whereas HA was not applied to the 20 patients who formed the CG.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• blood perfusion value in the recipient bed

  The comparison of blood perfusion value in the recipient bed between the TG and CG on day 4

  on day 4

Study Arms (2)

Test Group

ACTIVE COMPARATOR

Hyaluronic acid application group. After FGG was taken from the donor region in the TG, sterile gauze was applied with moderate pressure for 2 minutes, and HA was applied topically after the bleeding stopped. The cross-linked HA package containing 20 mg/ml Na-hyaluronate, stored at room temperature, was opened, and the protective cap of the syringe was removed.

Biological: Hyaluronic acid group

Control Group

NO INTERVENTION

In the control group (CG), HA was not applied to the recipient or the donor site.

Interventions

Hyaluronic acid group BIOLOGICAL

Applicaton of topical Hyaluronic acid

Test Group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Clinically diagnosed inadequate attached gingiva

You may not qualify if:

• Smoking

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Dentistry Department of Periodontology

Ankara, Çankaya, 06510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• Zeynep Turgut Çankaya

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: examiner blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: After FGG was taken from the donor region in the TG, sterile gauze was applied with moderate pressure for 2 minutes, and HA was applied topically after the bleeding stopped. In the TG, HA was applied to the entire recipient bed before suturing the graft taken from the palatial mucosa to the recipient site. In the control group (CG), HA was not applied to the recipient or the donor site.

Study Record Dates

• First Submitted: March 10, 2019
• First Posted: March 12, 2019
• Study Start: April 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 30, 2019

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)