NCT07465536

Brief Summary

This randomized controlled clinical trial aimed to compare postoperative outcames of conventional scalpel frenectomy and diode laser frenectomy with or without adjunctive photobiomodulation therapy. Postoperative pain, speech difficulty, chewing difficulty, analgesic consumption, and oral health-related quality of life (OHIP-14) were evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2016

Completed
9.8 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 6, 2026

Last Update Submit

March 6, 2026

Conditions

Frenulum; Hypertrophy, Lip

Outcome Measures

Primary Outcomes (4)

  • Postoperative Pain

    Postoperative pain intensity assessed using a Visual Analog Scale (VAS) following frenectomy procedures.

    Day 1 and Day 7 after surgery

  • Speech Difficulty

    Speech difficulty assessed using a Visual Analog Scale (VAS) following frenectomy procedures.

    Day 1 and Day 7 after surgery

  • Chewing Difficulty

    Chewing difficulty assessed using a Visual Analog Scale (VAS) following frenectomy procedures.

    Day 1 and Day 7 after surgery

  • Total Analgesic Consumption

    Total number of analgesic tablets consumed during the postoperative period.

    Within 7 days after surgery

Secondary Outcomes (5)

  • Plaque Index (PI)

    Baseline and 2 months after surgery

  • Gingival Index (GI)

    Baseline and 2 months after surgery

  • Probing Depth (PD)

    Baseline and 2 months after surgery

  • Keratinized Tissue Width (KTW)

    Baseline and 2 months after surgery

  • OHIP-14

    Baseline, Day 1 and Day 7 after surgery

Study Arms (4)

Scalpel Frenectomy

EXPERIMENTAL

Participants underwent conventional scalpel frenectomy for the treatment of aberrant maxillary labial frenulum.

Procedure: Scalpel Frenectomy

Scalpel Frenectomy + Photobiomodulation Therapy

EXPERIMENTAL

Participants underwent conventional scalpel frenectomy followed by adjunctive photobiomodulation therapy to enhance postoperative healing and reduce discomfort.

Procedure: Scalpel FrenectomyDevice: Photobiomodulation Therapy

Diode Laser Frenectomy

EXPERIMENTAL

Participants underwent frenectomy using an 810-nm diode laser for the treatment of aberrant maxillary labial frenulum.

Procedure: Diode Laser Frenectomy

Diode Laser Frenectomy + Photobiomodulation Therapy

EXPERIMENTAL

Participants underwent frenectomy using an 810-nm diode laser followed by adjunctive photobiomodulation therapy to enhance postoperative healing and reduce discomfort.

Procedure: Diode Laser FrenectomyDevice: Photobiomodulation Therapy

Interventions

Photobiomodulation TherapyDEVICE

Low-level laser therapy applied postoperatively to enhance wound healing and reduce postoperative pain and discomfort.

Diode Laser Frenectomy + Photobiomodulation TherapyScalpel Frenectomy + Photobiomodulation Therapy
Scalpel FrenectomyPROCEDURE

Conventional frenectomy performed using a surgical scalpel for the treatment of aberrant maxillary labial frenulum.

Scalpel FrenectomyScalpel Frenectomy + Photobiomodulation Therapy
Diode Laser FrenectomyPROCEDURE

Frenectomy performed using an 810-nm diode laser for the treatment of aberrant maxillary labial frenulum.

Diode Laser FrenectomyDiode Laser Frenectomy + Photobiomodulation Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Presence of clinically diagnosed aberrant maxillary labial frenal attachment requiring surgical frenectomy
  • Non-smoker status
  • Absence of systemic disease or ongoing pharmacological therapy
  • Absence of active oral infection
  • Ability to provide written informed consent

You may not qualify if:

  • Pregnancy or lactation
  • History of radiation therapy to the head and neck region
  • Previous frenectomy surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Faculty of Dentistry

Köseköy, Kocaeli, 41190, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HypertrophyLymphoid Interstitial Pneumonia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 12, 2026

Study Start

December 2, 2015

Primary Completion

March 16, 2016

Study Completion

May 6, 2016

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)