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

Sponsor

Marmara University (Other)

Overall Status

Completed

CT.gov ID

NCT02534415

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wound Healing Complication	Drug: Periodontal dressing material Drug: 0.2% Hyaluronic acid gel Drug: 0.8% Hyaluronic acid gel	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain [21 days]
Using a visual analog scale (0: No pain, 10: Severe pain)

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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