NCT03965455

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

9 months

First QC Date

May 24, 2019

Last Update Submit

May 24, 2019

Conditions

Keywords

labial frenumlaser therapyrecurrenceoral hyigiene

Outcome Measures

Primary Outcomes (1)

  • recurrence

    Recurrence is evaluated by the formation of an intact mucosa with the frenum attached to its new position

    6 weeks

Study Arms (2)

conventional group

Procedure: Conventional

diode laser group

Device: Diode laser

Interventions

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.

Also known as: frenectomy
diode laser group
ConventionalPROCEDURE

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.

Also known as: frenectomy
conventional group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • (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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Recurrence

Interventions

Lasers, SemiconductorOral FrenectomyCongresses as Topic

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and SuppliesOral Surgical ProceduresSurgical Procedures, OperativeDentistryOrganizationsHealth Care Economics and Organizations

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2019

First Posted

May 29, 2019

Study Start

February 23, 2018

Primary Completion

November 28, 2018

Study Completion

November 28, 2018

Last Updated

May 29, 2019

Record last verified: 2019-05

Locations