Hyaluronic Acid Application Following Frenectomy

Frenulum; Hypertrophy, Lip Clinical Trial

Official title:

Evaluation of the Effect on the Application of Hyaluronic Acid Following Laser-assisted Frenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03920553
• Other study ID #: 22.12.2018 18.5/9
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: April 11, 2019

Study information

• Verified date: April 2019
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 11, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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,

Related Conditions & MeSH terms

• Frenulum; Hypertrophy, Lip
• Hypertrophy

Intervention

Biological:
• Hyaluronic acid
Topical application of hyaluronic acid following Laser assisted frenectomy

Locations

Country	Name	City	State
Turkey	Zeynep Turgut Çankaya	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	the area of the wound surface was assessed at baseline and on days 3,7 and 14 days.