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Hyaluronic Acid Application Following Frenectomy

Primary Purpose

Frenulum; Hypertrophy, Lip

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hyaluronic acid
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frenulum; Hypertrophy, Lip

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • No systemic disease,
  • the presence of high labial frenulum attachment diagnosed according to Mirko et al., -periodontally healthy or a requirement for periodontal treatment that would only require removing of dental plaque,
  • full mouth plaque score <15%,probing pocket depth <3mm in all teeth
  • no history of periodontal surgery.

Exclusion Criteria:

  • not meet the optimal level of oral hygiene,
  • had any condition that could affect wound healing,
  • were pregnant or lactating,
  • were cigarette smokers or were takiing any medication that might affect the outcome of the study,

Sites / Locations

  • Zeynep Turgut Çankaya

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Test Group

Control Group

Arm Description

Preoperatively all patients gargled for 1 min with 0.2% chlorhexidine mouthwash. Local anaesthesia was applied to the area where the surgical procedure was to be applied. Then the frenectomy operation was performed with a continuous 970nm wavelength of the diode laser at power setting of 1,5W for approximately 60 seconds from the base to the apex of the frenum, thereby excising it. No bleeding was observed after the frenectomy performed with laser. Then, commercially available Hiyaluronic acid was topically applied to the relevant area to completely cover the surgical field to the test group. Following the frenectomy performed with laser, no application was made to the control group patients.

Preoperatively all patients gargled for 1 min with 0.2% chlorhexidine mouthwash. Local anaesthesia was applied to the area where the surgical procedure was to be applied. Then the frenectomy operation was performed with a continuous 970nm wavelength of the diode laser at power setting of 1,5W for approximately 60 seconds from the base to the apex of the frenum, thereby excising it.

Outcomes

Primary Outcome Measures

the change in the wound area surface
IMAGEJ software was used for the evaluation of the photographs and measurement of the area. The area unit measurements are determined by the operator and for this study, the unit was determined as mm2. To measure the area in the program, the relevant photograph was uploaded to the photograph file and the area to be measured was drawn with the computer mouse. After setting unit calibration, the area measurement was made automatically and the numerical value obtained was recorded in the Excel program.

Secondary Outcome Measures

Full Information

First Posted
April 13, 2019
Last Updated
July 29, 2019
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT03920553
Brief Title
Hyaluronic Acid Application Following Frenectomy
Official Title
Evaluation of the Effect on the Application of Hyaluronic Acid Following Laser-assisted Frenectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
April 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized clinical study aimed to compare the outcomes of the laser-assisted frenectomy with and without topical hyaluronic acid application to evaluate the effect of HA on secondary wound healing after frenectomy surgery. The study included a total of sytemically healthy 40 patients , with high labial frenulum attachment requiring frenectomy. Following laser-assisted frenectomy operation HA gel was applied to the wound surface in the test group, and no application was made to the control group The HA application was made topically to completely cover the surgical area on days 3, 7, and 14 postoperatively. Photographs of the operation area were taken on days 3, 7, and 14. The changes in the area measurements between the digital images according to the healing periods were calculated on a computer. according to Visual Analogue Scale (VAS) was used to evaluate Patient comfort and pain levels.
Detailed Description
the aim of this study was to clinically evaluate the effect on secondary wound healing of the topical application of hyaluronic acid to the surgical field after frenectomy operation performed with laser, through evaluation of the amount of reduction of the wound site and postoperative pain levels.The study included a total of 40 patients who had maxillary high labial frenulum attachment and were planned to undergo frenectomy and met the study inclusion criteria. All the patients were informed about oral hygiene control and attention was paid that optimal oral hygiene was maintained throughout the study. Phase I periodontal treatment was applied to patients where necessary. The area measurements of the wound site formed after frenectomy was taken immediately after the frenectomy and on days 3, 7, and 21 postoperatively. HA gel was applied topically after the frenectomy operation to the test group and not to the control group. All the surgical procedures were performed by the same surgeon.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frenulum; Hypertrophy, Lip

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Experimental
Arm Description
Preoperatively all patients gargled for 1 min with 0.2% chlorhexidine mouthwash. Local anaesthesia was applied to the area where the surgical procedure was to be applied. Then the frenectomy operation was performed with a continuous 970nm wavelength of the diode laser at power setting of 1,5W for approximately 60 seconds from the base to the apex of the frenum, thereby excising it. No bleeding was observed after the frenectomy performed with laser. Then, commercially available Hiyaluronic acid was topically applied to the relevant area to completely cover the surgical field to the test group. Following the frenectomy performed with laser, no application was made to the control group patients.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Preoperatively all patients gargled for 1 min with 0.2% chlorhexidine mouthwash. Local anaesthesia was applied to the area where the surgical procedure was to be applied. Then the frenectomy operation was performed with a continuous 970nm wavelength of the diode laser at power setting of 1,5W for approximately 60 seconds from the base to the apex of the frenum, thereby excising it.
Intervention Type
Biological
Intervention Name(s)
Hyaluronic acid
Intervention Description
Topical application of hyaluronic acid following Laser assisted frenectomy
Primary Outcome Measure Information:
Title
the change in the wound area surface
Description
IMAGEJ software was used for the evaluation of the photographs and measurement of the area. The area unit measurements are determined by the operator and for this study, the unit was determined as mm2. To measure the area in the program, the relevant photograph was uploaded to the photograph file and the area to be measured was drawn with the computer mouse. After setting unit calibration, the area measurement was made automatically and the numerical value obtained was recorded in the Excel program.
Time Frame
the area of the wound surface was assessed at baseline and on days 3,7 and 14 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: No systemic disease, the presence of high labial frenulum attachment diagnosed according to Mirko et al., -periodontally healthy or a requirement for periodontal treatment that would only require removing of dental plaque, full mouth plaque score <15%,probing pocket depth <3mm in all teeth no history of periodontal surgery. Exclusion Criteria: not meet the optimal level of oral hygiene, had any condition that could affect wound healing, were pregnant or lactating, were cigarette smokers or were takiing any medication that might affect the outcome of the study,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zeynep Turgut Çankaya
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zeynep Turgut Çankaya
City
Ankara
ZIP/Postal Code
06510
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Hyaluronic Acid Application Following Frenectomy

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