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Hyaluronic Acid Application Following Frenectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920553
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Zeynep Turgut Çankaya, Gazi University

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.


Condition or disease Intervention/treatment Phase
Frenulum; Hypertrophy, Lip Biological: Hyaluronic acid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect on the Application of Hyaluronic Acid Following Laser-assisted Frenectomy
Actual Study Start Date : January 2, 2019
Actual Primary Completion Date : March 15, 2019
Actual Study Completion Date : April 11, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test Group
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.
Biological: Hyaluronic acid
Topical application of hyaluronic acid following Laser assisted frenectomy

No Intervention: Control Group
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.



Primary Outcome Measures :
  1. the change in the wound area surface [ Time Frame: the area of the wound surface was assessed at baseline and on days 3,7 and 14 days. ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920553


Locations
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Turkey
Zeynep Turgut Çankaya
Ankara, Turkey, 06510
Sponsors and Collaborators
Gazi University
Investigators
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Principal Investigator: zeynep Turgut Çankaya Gazi University
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Responsible Party: Zeynep Turgut Çankaya, Principal Investigator, Gazi University
ClinicalTrials.gov Identifier: NCT03920553    
Other Study ID Numbers: 22.12.2018 18.5/9
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertrophy
Pathological Conditions, Anatomical
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents