Effect of Topically-Applied Hyaluronic-Acid on Palatal Epithelial Wound Closure

Aim of the study is to assess the therapeutic effects of topical hyaluronic-acid use on secondary wound healing of the free gingival graft donor site. The hypothesis of this study is that topical hyaluronic-acid gel has positive effects on secondary wound healing of free gingival graft donor site by reducing pain, burning sensation, and accelerating the healing.

Study Overview

• Status: Completed
• Conditions: Wound Healing Complication
• Intervention / Treatment: Drug: Periodontal dressing material; Drug: 0.2% Hyaluronic acid gel; Drug: 0.8% Hyaluronic acid gel

Detailed Description

The objective of the randomized, single blind, controlled and parallel clinical trial was to assess therapeutic effects of topical hyaluronic-acid on secondary wound healing of free gingival graft donor site.

Primary outcome variables that pain and burning sensation changes were assessed at 3, 7, 14, 21 days after surgery by the examiner. Pain and burning sensation were assessed by patients using the VAS, score 0 indicate no pain or burning sensation, score 10 indicate severe pain or burning sensation. Secondary outcome variables included color match, consistency and epithelization of the wound area. These parameters were assessed by the same examiner at 3, 7, 14, 21 and 42 days after surgery. Color of the palatal mucosa was assessed by comparing it to that of the adjacent and opposite site using the VAS. Score 0 indicate no color match and score 10 indicate very good color match. Consistency of the palatal mucosa was assessed with a blunt instrumentation and scored as soft or firm. Epithelialization was scored clinically as none, partial or complete.

Sample size has been estimated in 12 subjects per treatment groups. Random allocation of the treatment sites to test and control groups will be performed using a computerized selection of random numbers for allocation of the study groups.

Clinical images obtained at baseline, 3, 7, 14, 21 and 42 days after surgery from each treatment site.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Good general health
• No periodontal surgical treatment in the previous 6 months on the involved sites

Exclusion Criteria:

• Smoking
• Patients with a pregnancy or lactation period
• Self-reported history of antibiotic medication within three months
• Absence of tooth in the area of donor site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Periodontal dressing material; Palatal wound area was covered with periodontal dressing material at baseline and 3rd day	Drug: Periodontal dressing material; Procedure:Palatal wound area was covered with periodontal dressing material at baseline and 3rd day; Other Names: Peripac®
Experimental: 0.2% Hyaluronic acid gel; 0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day	Drug: 0.2% Hyaluronic acid gel; 0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day; Other Names: Gengigel
Experimental: 0.8% Hyaluronic acid gel; 0.8% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day	Drug: 0.8% Hyaluronic acid gel; 0.8% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day; Other Names: Gengigel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Using a visual analog scale (0: No pain, 10: Severe pain)	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Color match	Using a visual analog scale (0: No color match, 10: Good color match) (Adjacent and opposite site)	42 days
Consistency	Soft/firm	42 days
Epithelialisation	None/partial/complete	42 days
Burning Sensation	Using a visual analog scale (0: No burning sensation, 10: Severe burning sensation)	21 days

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Study Director: Bahar Kuru, Prof. Dr., Marmara University, Faculty of Denistry, Department of Periodontology; Study Chair: Başak Doğan, Prof. Dr., Marmara University, Faculty of Denistry, Department of Periodontology; Principal Investigator: Hatice Selin Yıldırım, Dr., Marmara University, Faculty of Denistry, Department of Periodontology

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: August 25, 2015
• First Posted (Estimate): August 27, 2015

Study Record Updates

• Last Update Posted (Estimate): August 27, 2015
• Last Update Submitted That Met QC Criteria: August 25, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Wound healing; Gingiva; Hyaluronic acid; Transplants; Palate; Antiinflammatory
• Additional Relevant MeSH Terms: Wounds and Injuries; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: YU-351