Hyaluronic Acid Application Following Frenectomy

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.

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Key information

Conditions

Frenulum; Hypertrophy, Lip Hypertrophy Lymphoid Interstitial Pneumonia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zeynep Turgut Çankaya

Ankara, 06510, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Hyaluronic Acid

Biological

Topical application of hyaluronic acid following Laser assisted frenectomy

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Apr 19, 2019
Registry last updated: Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed