Clinical trial NCT06548516: Maxillary Labial Frenectomy: Diode Lasers Versus Surgical Scalpel
Official title: Evaluation of Patients' Perceptions and Soft Tissue Changes After Conventional and Diode Laser Frenectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Frenum Attachment
Keywords: Maxillary Labial Frenum
Frenectomy
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine if diode laser treatment can improve post-operative outcomes compared to conventional scalpel technique in systemically healthy, non-smoking adults aged 18-45 years with aberrant papillary frenum attachment. The main questions it aims to answer are:

Does diode laser treatment result in lower post-operative pain compared to the conventional scalpel technique? Does diode laser treatment result in better periodontal healing outcomes compared to the conventional scalpel technique? Researchers will compare the diode laser surgery group to the conventional scalpel surgery group to see if there are differences in pain and healing.

Participants will:

Undergo a frenectomy procedure using either a diode laser or a conventional scalpel.

Receive oral hygiene instructions and post-operative care recommendations. Have their periodontal parameters measured at baseline, 6 weeks, and 6 months post-operation.

Record their pain levels using a visual analogue scale on specified post-operative days.

Detailed description: The trial will be performed as a prospective, randomized and controlled, single-blind investigation to study clinical parameters and patients' experiences when performing a frenectomy, comparing diode laser treatment with the conventional scalpel technique.

Participants:

This study will include 43 participants who will be identified with aberrant papillary frenum attachment according to Mirko et al., and will be referred to the periodontology department. The inclusion criteria for the participants will be:

All participants will sign a written informed consent form before participating in the study.

Study Groups and Randomization:

Before any surgical procedure, all subjects will undergo a thorough medical and dental history review, as well as intraoral and radiographic examinations. Participants who match the inclusion criteria will be provided with oral hygiene instructions tailored to their specific needs. Initially, the clinical periodontal parameters of all participants will be measured. Then, a mechanical cleaning procedure will be carried out using an ultrasonic scaler (CavitronÒ; Dentsply International) and hand instruments (Gracey, 5/6, 7/8, 11/12, 13/14; Hu-Friedy Ins. Co.). A total of 43 participants will be enrolled in the study and assigned to one of two groups using a computer-based randomization table (www.graphpad.com/quickcalcs). The participants will be randomly divided into two groups: the experimental group, which will undergo diode laser surgery (L=20), and the control group, which will undergo conventional scalpel surgery (C=23).

Post-treatment Procedure:

After the frenectomy procedures in all groups, patients will receive oral hygiene instructions and will be advised to consume soft and cold food for the next 12 hours. Additionally, a 0.12% chlorhexidine gluconate mouth rinse will be prescribed to be used once a day for one minute over five days. For pain relief, 500 mg of acetaminophen (1-2 tablets) will be prescribed as needed, with patients instructed to record the dosage and frequency of use.

Clinical Evaluation:

Z.T.E. will perform all surgical procedures, while a calibrated single examiner (K.Y) will perform all clinical evaluations. Patients in the C group will undergo primary wound healing with sutures, whereas patients in the L group will not get any sutures. Therefore, neither the clinicians (Z.T.E and K.Y) nor the patients will be kept unaware of the study's details over the entire duration. In order to ensure consistency in the measurements of K.Y, a calibration exercise was conducted until the agreement coefficient achieves a level of 90%. This calibration process was consist of evaluating three patients on two separate occasions within a 24-hour period. The calibration was considered effective if the variation between repeated measurements of periodontal keratinized gingival width (KGW) at the beginning and after 24 hours is less than 3%. The clinical periodontal parameters, such as the plaque index (PI), gingival index (GI), and periodontal pocket depth (PD), will be measured using a periodontal probe from the University of North Carolina (PCPUNC15; Hu-Friedy Ins. Co.). At baseline and at postoperative week 6 and month 6, all periodontal measurements will be taken at six sites per tooth as part of a full-mouth evaluation. KGW on teeth 11 and 12, the heights of the interdental papillae between the incisors (from the tip of an interdental papilla to the line joining the lowest points on the gingival margins of adjacent incisors), interdental papilla width, and the amount of diastema will be measured at baseline and at month 6. Before the operations, the labial frenulum attachments will be classified into four types: I - mucosal attachment; II - gingival attachment; III - papillary attachment; and IV - papilla penetrating attachment. Pain will be evaluated using the visual analogue scale (VAS) on postoperative days 1, 3, 7, 14, 21, and 28. The scale will be comprised of a horizontal line with values ranging from '0' to '10', where '0' indicates the absence of pain and '10' indicates the presence of severe discomfort.

Statistical Analysis:

Each patient will be accepted as one statistical unit and the statistical analysis will be performed by SPSS 20 (SPSS Corporation, Chicago, IL) with a significance level p \< 0.05. The Kolmogorov-Smirnov test will be used to check the distribution for normality. Repeated measurements of clinical parameters will be analyzed with Friedman test and Wilcoxon signed-rank test. The Kruskal-Wallis, Chi-square, and Fisher's exact tests will be used to determine differences among the groups. Moreover, in case of significant difference among groups, the Mann-Whitney U test will be used to compare two groups by Bonferroni correction.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy
* Nonsmoker
* No periodontal treatment received in the last 3 months
* Having at least 20 teeth
* Presence of at least central incisors, lateral incisors, and canines in the maxilla
* Not pregnant or breastfeeding
* No psychiatric, mental, or physical impairments
* Diagnosed with gingival health based on the "World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions
* Consent to participate in the study.

Exclusion Criteria:

* Any systemic disease that could interfere with the wound healing process (e.g., diabetes mellitus and HIV infection)
* Smoking
* Use of antibiotics, anti-inflammatory drugs, or any other medication in the last 6 months that could affect the study's outcome
* Any hypersensitivity reactions to paracetamol
* Any physical limitations or restrictions that could impede normal oral hygiene procedures.

Primary outcomes:
measure: Postoperative pain
timeFrame: postoperative days 1, 3, 7, 14, 21, and 28.
measure: Postoperative tissue healing
timeFrame: postoperative days 7 and 30 after surgery,
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University, dentistry Faculty
Study officials:
affiliation: Necmettin Erbakan University
name: zeynep taştan eroğlu
role: PRINCIPAL_INVESTIGATOR
References: