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

Phase 4

Completed

• Conditions: Wound Healing Complication
• Interventions: Drug: Periodontal dressing material; Drug: 0.2% Hyaluronic acid gel; Drug: 0.8% Hyaluronic acid gel

• Registration Number: NCT02534415
• Lead Sponsor: Marmara University

Brief Summary

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.

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 Timeline

• Study Start: 2013-08
• Primary Completion: 2015-07
• Status Verified: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-25
• Last Update Submitted: 2015-08-25
• Study First Posted: 2015-08-27
• Last Update Posted: 2015-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periodontal dressing material	Periodontal dressing material	Palatal wound area was covered with periodontal dressing material at baseline and 3rd day
0.2% Hyaluronic acid gel	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
0.8% Hyaluronic acid gel	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

Primary Outcome Measures

Name	Time	Method
Pain	21 days	Using a visual analog scale (0: No pain, 10: Severe pain)

Secondary Outcome Measures

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