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

Wound Healing Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534415
• Other study ID #: YU-351
• Status: Completed
• Phase: Phase 4
• First received: August 17, 2015
• Last updated: August 25, 2015
• Start date: August 2013
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wound Healing Complication

Intervention

Drug:
• Periodontal dressing material
Procedure:Palatal wound area was covered with periodontal dressing material at baseline and 3rd day
• 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% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Using a visual analog scale (0: No pain, 10: Severe pain)	21 days	No
Secondary	Color match	Using a visual analog scale (0: No color match, 10: Good color match) (Adjacent and opposite site)	42 days	No
Secondary	Consistency	Soft/firm	42 days	No
Secondary	Epithelialisation	None/partial/complete	42 days	No
Secondary	Burning Sensation	Using a visual analog scale (0: No burning sensation, 10: Severe burning sensation)	21 days	No