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

Primary Purpose

Wound Healing Complication

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Periodontal dressing material
0.2% Hyaluronic acid gel
0.8% Hyaluronic acid gel
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Healing Complication focused on measuring Antiinflammatory, Gingiva, Hyaluronic acid, Palate, Transplants, Wound healing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Periodontal dressing material

    0.2% Hyaluronic acid gel

    0.8% Hyaluronic acid gel

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Pain
    Using a visual analog scale (0: No pain, 10: Severe pain)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 17, 2015
    Last Updated
    August 25, 2015
    Sponsor
    Marmara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02534415
    Brief Title
    Effect of Topically-Applied Hyaluronic-Acid on Palatal Epithelial Wound Closure
    Official Title
    Effect of Topically-Applied Hyaluronic-Acid on Palatal Epithelial Wound Closure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Marmara University

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wound Healing Complication
    Keywords
    Antiinflammatory, Gingiva, Hyaluronic acid, Palate, Transplants, Wound healing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Periodontal dressing material
    Arm Type
    Active Comparator
    Arm Description
    Palatal wound area was covered with periodontal dressing material at baseline and 3rd day
    Arm Title
    0.2% Hyaluronic acid gel
    Arm Type
    Experimental
    Arm Description
    0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
    Arm Title
    0.8% Hyaluronic acid gel
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Name(s)
    Periodontal dressing material
    Other Intervention Name(s)
    Peripac®
    Intervention Description
    Procedure:Palatal wound area was covered with periodontal dressing material at baseline and 3rd day
    Intervention Type
    Drug
    Intervention Name(s)
    0.2% Hyaluronic acid gel
    Other Intervention Name(s)
    Gengigel
    Intervention Description
    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
    Intervention Name(s)
    0.8% Hyaluronic acid gel
    Other Intervention Name(s)
    Gengigel
    Intervention Description
    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 Measure Information:
    Title
    Pain
    Description
    Using a visual analog scale (0: No pain, 10: Severe pain)
    Time Frame
    21 days
    Secondary Outcome Measure Information:
    Title
    Color match
    Description
    Using a visual analog scale (0: No color match, 10: Good color match) (Adjacent and opposite site)
    Time Frame
    42 days
    Title
    Consistency
    Description
    Soft/firm
    Time Frame
    42 days
    Title
    Epithelialisation
    Description
    None/partial/complete
    Time Frame
    42 days
    Title
    Burning Sensation
    Description
    Using a visual analog scale (0: No burning sensation, 10: Severe burning sensation)
    Time Frame
    21 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bahar Kuru, Prof. Dr.
    Organizational Affiliation
    Marmara University, Faculty of Denistry, Department of Periodontology
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Başak Doğan, Prof. Dr.
    Organizational Affiliation
    Marmara University, Faculty of Denistry, Department of Periodontology
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Hatice Selin Yıldırım, Dr.
    Organizational Affiliation
    Marmara University, Faculty of Denistry, Department of Periodontology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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