Clinical trial NCT03920553: Hyaluronic Acid Application Following Frenectomy
Official title: Evaluation of the Effect on the Application of Hyaluronic Acid Following Laser-assisted Frenectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frenulum; Hypertrophy, Lip
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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,

Primary outcomes:
measure: the change in the wound area surface
timeFrame: the area of the wound surface was assessed at baseline and on days 3,7 and 14 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zeynep Turgut Çankaya
Study officials:
affiliation: Gazi University
name: zeynep Turgut Çankaya
role: PRINCIPAL_INVESTIGATOR
References: