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

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ClinicalTrials.gov Identifier: NCT02534415
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : August 27, 2015
Sponsor:
Information provided by (Responsible Party):
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.

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 Type : Interventional  (Clinical Trial)
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 : August 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Gengigel




Primary Outcome Measures :
  1. Pain [ Time Frame: 21 days ]
    Using a visual analog scale (0: No pain, 10: Severe pain)


Secondary Outcome Measures :
  1. Color match [ Time Frame: 42 days ]
    Using a visual analog scale (0: No color match, 10: Good color match) (Adjacent and opposite site)

  2. Consistency [ Time Frame: 42 days ]
    Soft/firm

  3. Epithelialisation [ Time Frame: 42 days ]
    None/partial/complete

  4. Burning Sensation [ Time Frame: 21 days ]
    Using a visual analog scale (0: No burning sensation, 10: Severe burning sensation)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534415


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

Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT02534415     History of Changes
Other Study ID Numbers: YU-351
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015

Keywords provided by Marmara University:
Antiinflammatory
Gingiva
Hyaluronic acid
Palate
Transplants
Wound healing

Additional relevant MeSH terms:
Wounds and Injuries
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents