Retrospective Frenectomy Analysis: Techniques and Adjunctive Antimicrobials

"Evaluating the Impact of Diverse Antimicrobial Agents on Clinical Outcomes of Various Frenectomy Techniques: A Retrospective Study"

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.

Study Overview

• Status: Completed
• Conditions: Antimicrobial Agent; Frenectomy; Erbium YAG Laser

Detailed Description

The frenulum is a mucosal fold, usually containing closed muscle fibers, that connects the lips and cheeks to the alveolar mucosa and/or gingiva and underlying periosteum. The frenulum problem is most common on the labial surface between the maxillary and mandibular central incisors and in the canine and premolar areas. 1 The labial frenulum restricts and stabilizes lip movement and can also cause gingival recession. 1 Depending on the attachment extension of the fibers, the frenulum is classified as follows: Mucosal; when the frenal fibers are attached up to the mucogingival junction, Gingiva; when fibers are placed inside the attached gingiva, Papillary; when fibers extend towards the interdental papilla, Penetrating the papilla; when the frenal fibers cross the alveolar process and extend to the palatine papilla. 2 Clinically, papillary and papillary-penetrating frenulum are considered pathologic and have been associated with papilla loss, recession, diastema, difficulty in brushing, tooth alignment and psychological disturbances of the individual. 3,4 Frenectomy is the complete removal of the frenulum, including its attachment to the underlying bone. There are two techniques for frenectomy. One is the traditional technique using scalpels and periodontal blades, and the other is the technique using soft tissue lasers. 5,6 Er:YAG is highly effective in cutting soft tissues. Its wavelength is 2940 nm, allowing for shallow penetration and a high water absorption rate. This type of laser can be strongly absorbed by water molecules in the irradiated area, producing a photoelectric effect that causes the water temperature to rise sharply.

Both techniques have some disadvantages; the traditional scalpel technique results in a large rhomboidal wound area at the bottom where primary closure is not possible, and healing occurs with secondary intention. It also causes more pain and discomfort to the patient compared to the laser technique. 7 On the other hand, the laser is an expensive device, and its use requires more precision and control, causing bone necrosis if the beam contacts the bone surface.

Chlorhexidine (CHX) is a cationic bisbiguanide compound with broad-spectrum antimicrobial properties. Although the mouthwash form is most used in dentistry after surgical procedures, gel, spray and dental varnish forms are also preferred for their antiplaque and healing acceleration properties. 8 Klorhex Plus mouthwash, containing 0.5 g flurbiprofen and 0.24 g chlorhexidine digluconate has also been shown to have significant contributions in reducing edema and accelerating wound healing in oral wounds.9

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Turkey
  • Keçi̇ören
    • Ankara, Keçi̇ören, Turkey
      • Health Sciences University Gulhane Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Actual): May 15, 2025
• Study Completion (Actual): May 15, 2025

Study Registration Dates

• First Submitted: June 27, 2025
• First Submitted That Met QC Criteria: June 27, 2025
• First Posted (Actual): July 8, 2025

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: wound healing; chlorhexidine; visual analog scale; frenectomy; erbium yag laser
• Other Study ID Numbers: Seval2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It will not be shared as it contains personal data belonging to patients.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No