Hyaluronic Acid Application Following Frenectomy
|ClinicalTrials.gov Identifier: NCT03920553|
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : July 30, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920553
|Zeynep Turgut Çankaya|
|Ankara, Turkey, 06510|
|Principal Investigator:||zeynep Turgut Çankaya||Gazi University|