Clinical Efficacy of Conventional and Diode Laser-Assisted Frenectomy in Patients With Abnormal Different Frenum Insertions: A Retrospective Study

May 24, 2019 updated by: Marmara University

Aim: The aim of this retrospective study was to assess the frenum attachment recurrence and evaluate clinical parameters after conventional and diode laser-assisted frenectomy in patients with different abnormal frenum insertions.

Methods: Data records of 429 patients treated with maxillary labial frenectomy between January 1, 2016 and January 1, 2018 were screened. Records of 70 patients meeting the inclusion criteria were evaluated. Data were analyzed in terms of gender, age, category of frenum, presence of diastema, operation technique, type of periodontal disease. The distance between frenum attachment and mucogingival junction (FMGJ), plaque index (PI), gingival index (GI) and probing depth were assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Maltepe
      • İstanbul, Maltepe, Turkey, 34854
        • Marmara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study utilized treatment records of patients treated with maxillary labial frenectomy in the Clinics of Periodontology, Faculty of Dentistry, Marmara University.

Description

Inclusion Criteria:

(a) systemically healthy, (b) nonsmoker, (c) aged between 18 and 65 years, (d) received initial periodontal treatment before frenectomy, (e) presence of central and lateral incisors and canines at maxilla, (f) not received any kind of periodontal surgery, prosthodontic and restorative treatment which may affect the anatomy of the relevant region.

Exclusion Criteria:

Subjects with incomplete documentation and without at least 6-week follow-up observation were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
conventional group
Procedure: Conventional
In the conventional frenectomy, the incisions were applied using a scalpel blade no.15 on the upper and lower surface of the haemostat until the frenum was excised.
Other Names:
  • frenectomy
diode laser group
Device: Diode laser
In the laser-assisted frenectomy, a diode laser device (GIGA Cheese II®, China) (λ= 810 nm) with a 400 µm diameter, plain-ended optical fiber tip was used for the procedure maintaining contact with oral mucosa at 2,5 W, 70 Hz frequency with a short pulse (140 microseconds) duration.
Other Names:
  • frenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence
Time Frame: 6 weeks
Recurrence is evaluated by the formation of an intact mucosa with the frenum attached to its new position
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2018

Primary Completion (Actual)

November 28, 2018

Study Completion (Actual)

November 28, 2018

Study Registration Dates

First Submitted

May 24, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (Actual)

May 29, 2019

Study Record Updates

Last Update Posted (Actual)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 24, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018-164

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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