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

Frenulum; Elongation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03965455
• Other study ID #: 2018-164
• Status: Completed
• Start date: February 23, 2018
• Est. completion date: November 28, 2018

Study information

• Verified date: May 2019
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 28, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Frenulum; Elongation

Intervention

Device:
• Diode laser
In the laser-assisted frenectomy, a diode laser device (GIGA Cheese II®, China) (?= 810 nm) with a 400 µm diameter, plain-ended optical ?ber 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.

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.

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul	Maltepe

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence	Recurrence is evaluated by the formation of an intact mucosa with the frenum attached to its new position	6 weeks