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Completed

NCT Number: NCT02534415

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periodontal dressing material

Drug

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

Other names: Peripac®

0.2% hyaluronic acid gel

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

Other names: Gengigel

0.8% Hyaluronic acid gel

Drug

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

Primary outcomes

  1. Pain

    Time frame: 21 days

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

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 27, 2015
Registry last updated
Aug 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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