Retrospective Frenectomy Analysis: Techniques and Adjunctive Antimicrobials

NCT07054021 | Completed DMC

• 1 other identifier: Seval2
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The frenulum is a mucosal fold that connects the lips and cheeks to the alveolar mucosa or gingiva, with abnormal attachments-particularly papillary and papillary-penetrating types-linked to clinical issues such as gingival recession, diastema, and oral hygiene difficulties. Frenectomy, the complete removal of the frenulum, can be performed using traditional scalpel techniques or soft tissue lasers like Er:YAG, which offers precise cutting with minimal thermal damage. While laser surgery reduces pain and promotes faster healing, it requires careful control and involves higher costs. Postoperative care often includes chlorhexidine-based agents due to their antimicrobial and healing-promoting properties; combinations like Klorhex Plus (chlorhexidine digluconate and flurbiprofen) have demonstrated effectiveness in reducing edema and enhancing wound healing.

Conditions

Frenectomy; Erbium YAG Laser; Antimicrobial Agent

Keywords

frenectomy; erbium yag laser; chlorhexidine; wound healing; visual analog scale

Outcome Measures

Primary Outcomes (1)

• Wound healing (WHI) was used as the primary outcome measure.

  Wound healing was scored according to WHI 14. The WHI was recorded on the 7th, 14th and 28th days. The primary outcome of the study was to measure the palatal wound healing status using the WHI, which grades the wound healing on a scale. This index, which has a score range of 1 (very poor) to 5 (excellent), evaluates tissue color, response to palpation, granulation tissue presence, incision margins' epithelialization, and amount of suppuration

  The WHI was recorded on the 7th, 14th and 28th days.

Secondary Outcomes (1)

• Postoperative pain was evaluated as a secondary outcome.

  The secondary results of the study showed that patients' perceptions of pain after surgical procedures were rated on a numerical rating scale from; VAS 0 (no pain) and 100 (the most severe pain imaginable) between days 1 and 7 and post-surgery.

Study Arms (4)

Conventional Surgery + Postoperative Chlorobene use of mouthwash

Er:Yag laser surgery + Postoperative use of Chlorobene mouthwash

Conventional surgery + Postoperative use of Chlorhex plus mouthwash

Er:Yag laser surgery + Postoperative use of Chlorhex plus mouthwash

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Among 463 patients who applied to Gülhane Faculty of Dentistry, Department of Periodontology for frenectomy indication between January 2023 and March 2025, a total of 102 patients who were treated with the traditional method and Er:Yag laser were included in the study.

You may qualify if:

• Patients who presented to the Department of Periodontology, Gülhane Faculty of Dentistry between January 1, 2023, and March 1, 2025, and underwent maxillary labial frenectomy.
• Patients from whom a complete and signed surgical informed consent form was obtained.
• Patients with complete clinical measurements recorded at baseline, and on postoperative days 7, 14, and 28.
• Patients whose wound healing was scored using the Landry Wound Healing Index and documented on days 7, 14, and 28 postoperatively.
• Patients whose epithelialization status was evaluated and documented on postoperative days 7, 14, and 28.
• Patients who received one of the following treatment protocols:
• Conventional surgery + postoperative use of Kloroben mouthwash,
• Er:YAG laser surgery + postoperative use of Kloroben mouthwash,
• Conventional surgery + postoperative use of Klorhex Plus mouthwash,
• Er:YAG laser surgery + postoperative use of Klorhex Plus mouthwash.
• Patients who completed a written pain assessment using the Visual Analog Scale (VAS) daily for one week postoperatively.
• Patients who documented postoperative bleeding and the number of analgesic intakes in written form.

You may not qualify if:

• Patients who presented to the Department of Periodontology, Gülhane Faculty of Dentistry between January 1, 2023, and March 1, 2025, and underwent mandibular labial frenectomy.
• Patients with incomplete or missing surgical informed consent forms.
• Patients for whom clinical measurements, Landry wound healing scores, and hydrogen peroxide (H₂O₂) tests were not performed.
• Patients treated with diode laser.
• Patients whose postoperative VAS pain records, number of analgesics used, and bleeding status were not documented.
• Patients who received postoperative antibiotic therapy.
• Patients who did not use Kloroben or Klorhex Plus mouthwash postoperatively.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Health Sciences University Gulhane Faculty of Dentistry

Ankara, KEÇİÖREN, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asist prof

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: May 15, 2025
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: July 14, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)