Clinical trial NCT02534415: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wound Healing Complication
Keywords: Antiinflammatory
Gingiva
Hyaluronic acid
Palate
Transplants
Wound healing
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain
timeFrame: 21 days
Secondary outcomes:
measure: Color match
timeFrame: 42 days
measure: Consistency
timeFrame: 42 days
measure: Epithelialisation
timeFrame: 42 days
measure: Burning Sensation
timeFrame: 21 days
Other outcomes:
Locations:
Study officials:
affiliation: Marmara University, Faculty of Denistry, Department of Periodontology
name: Bahar Kuru, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Marmara University, Faculty of Denistry, Department of Periodontology
name: Başak Doğan, Prof. Dr.
role: STUDY_CHAIR
affiliation: Marmara University, Faculty of Denistry, Department of Periodontology
name: Hatice Selin Yıldırım, Dr.
role: PRINCIPAL_INVESTIGATOR
References: