Maxillary Labial Frenectomy: Diode Lasers Versus Surgical Scalpel

NCT06548516 | Recruiting

• 1 other identifier: frenektomilaserandconvantional
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

High Frenum Attachment

Keywords

Maxillary Labial Frenum; Frenectomy

Outcome Measures

Primary Outcomes (2)

• Postoperative pain

  Pain will be evaluated using the visual analogue scale (VAS).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.

  postoperative days 1, 3, 7, 14, 21, and 28.

• Postoperative tissue healing

  Tissue healing will be assessed by Z.T.E using the following scoring system: * Score 1: Complete epithelialization * Score 2: Incomplete epithelialization * Score 3: Presence of ulcer * Score 4: Tissue defect or necrosis

  postoperative days 7 and 30 after surgery,

Study Arms (2)

Control group (conventional scalpel surgery)

ACTIVE COMPARATOR

After administering local infiltrative anesthesia with articaine hydrochloric acid combined with epinephrine 1:100,000, the frenum will be grasped with a straight hemostat positioned in the vestibule. The tissue adjacent to the upper and lower surfaces of the hemostat will then be incised using a no.15 scalpel. The excised diamond-shaped portion of the frenum will be removed with the hemostat. Subsequently, a horizontal incision will be made on the periosteum with a scalpel to prevent fiber reattachment. The wound site will be primarily closed using absorbable sutures (4/0, Pegelak), which will be removed one week post-operatively.

Procedure: Control group (conventional scalpel surgery)

Diode laser group

EXPERIMENTAL

The frenectomy procedure will be performed under local infiltrative anesthesia, specifically articaine hydrochloric acid with epinephrine 1:100,000. A straight hemostat, similar to that used in the C group, will be employed to secure the frenum. Laser energy will be applied to the upper and lower sections of the frenum adjacent to the hemostat, utilizing a diode laser device equipped with a 400 µm diameter, plain-ended optical fiber tip. Frenectomy will performed with a 980 nm diode laser with 1.7 W power in continuous wave mode.The wound site will be allowed to heal by secondary intention without the application of sutures.

Procedure: Diode laser group

Interventions

Control group (conventional scalpel surgery) PROCEDURE

The patients in the control group will undergo frenectomy using conventional scalpel surgery.

Control group (conventional scalpel surgery)

Diode laser group PROCEDURE

The patients in the laser group will undergo frenectomy using a diode laser.

Diode laser group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University, dentistry Faculty

Konya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• zeynep taştan eroğlu

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zeynep taştan eroğlu

CONTACT

00905065857095; dt.zeyneptastan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients in the C group underwent primary wound healing with sutures, whereas patients in the L group did not get any sutures. Therefore, neither the clinicians (Z.T.E and K.Y) nor the patients were kept unaware of the study's details over the entire duration
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 12, 2024
• Study Start: April 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

TU (1)