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

NCT ID: NCT03871218

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2018-12-01

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.

Detailed Description

The healing of a transplanted tissue depends on the formation of blood support between the donor and recipient sites.

Hyaluronic acid (HA) is a biomaterial that creates a favorable environment for wound healing due to its unique hydroscopic and viscoelastic properties, and it is important for wound healing activities.HA induces angiogenesis following degradation and improves the wound healing environment.HA supports a mechanism that induces proliferation of capillaries, and components produced after HA degradation increase vascularization.Laser Doppler flowmetry (LDF) technique is frequently used in the field of plastic surgery for monitoring microvascular blood flow to detect insufficient circulation in the skin transplants and flaps in the early period and to thereby prevent and predict possible surgical complications.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test Group

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.

Group Type: ACTIVE_COMPARATOR

Hyaluronic acid group

Intervention Type: BIOLOGICAL

Applicaton of topical Hyaluronic acid

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hyaluronic acid group

Applicaton of topical Hyaluronic acid

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Clinically diagnosed inadequate attached gingiva

Exclusion Criteria

• Smoking

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Turgut Çankaya

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeynep Turgut Çankaya

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

Gazi University Faculty of Dentistry Department of Periodontology

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

19.04.2017 08/14

Identifier Type: -

Identifier Source: org_study_id