NCT02534415

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

1.9 years

First QC Date

August 17, 2015

Last Update Submit

August 25, 2015

Conditions

Keywords

AntiinflammatoryGingivaHyaluronic acidPalateTransplantsWound healing

Outcome Measures

Primary Outcomes (1)

  • Pain

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

    21 days

Secondary Outcomes (4)

  • Color match

    42 days

  • Consistency

    42 days

  • Epithelialisation

    42 days

  • Burning Sensation

    21 days

Study Arms (3)

Periodontal dressing material

ACTIVE COMPARATOR

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

Drug: Periodontal dressing material

0.2% Hyaluronic acid gel

EXPERIMENTAL

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

0.8% Hyaluronic acid gel

EXPERIMENTAL

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

Interventions

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

Also known as: Peripac®
Periodontal dressing material

0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day

Also known as: Gengigel
0.2% 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

Also known as: Gengigel
0.8% Hyaluronic acid gel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Good general health
  • No periodontal surgical treatment in the previous 6 months on the involved sites

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Peripac

Study Officials

  • Bahar Kuru, Prof. Dr.

    Marmara University, Faculty of Denistry, Department of Periodontology

    STUDY DIRECTOR
  • Başak Doğan, Prof. Dr.

    Marmara University, Faculty of Denistry, Department of Periodontology

    STUDY CHAIR
  • Hatice Selin Yıldırım, Dr.

    Marmara University, Faculty of Denistry, Department of Periodontology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2015

First Posted

August 27, 2015

Study Start

August 1, 2013

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

August 27, 2015

Record last verified: 2015-08