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

NCT ID: NCT02534415

Last Updated: 2015-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Wound Healing Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Periodontal dressing material

Palatal wound area was covered with periodontal dressing material at baseline and 3rd day

Group Type ACTIVE_COMPARATOR

Periodontal dressing material

Intervention Type DRUG

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

Group Type EXPERIMENTAL

0.2% Hyaluronic acid gel

Intervention Type DRUG

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

Group Type EXPERIMENTAL

0.8% Hyaluronic acid gel

Intervention Type DRUG

0.8% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day

Interventions

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Periodontal dressing material

Procedure:Palatal wound area was covered with periodontal dressing material at baseline and 3rd day

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Peripac® Gengigel Gengigel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bahar Kuru, Prof. Dr.

Role: STUDY_DIRECTOR

Marmara University, Faculty of Denistry, Department of Periodontology

Başak Doğan, Prof. Dr.

Role: STUDY_CHAIR

Marmara University, Faculty of Denistry, Department of Periodontology

Hatice Selin Yıldırım, Dr.

Role: PRINCIPAL_INVESTIGATOR

Marmara University, Faculty of Denistry, Department of Periodontology

Other Identifiers

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YU-351

Identifier Type: -

Identifier Source: org_study_id

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