Clinical Evaluation of Postoperative Healing After Conventional And Laser Assisted Frenectomy Operations

Frenulum; Hypertrophy, Lip Clinical Trial

Official title:

Clinical Evaluation of Postoperative Healing After Conventional And Laser Assisted Frenectomy Operations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552809
• Other study ID #: Cetinkaya et al.
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: October 2017

Study information

• Verified date: June 2018
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this randomized controlled parallel-designed study was to evaluate clinical healing and patient comfort after conventional and diode laser assisted frenectomy operations in case of high papillary frenulum attachment. Forty-eight patients with high papillary frenulum attachments were included in the study. Patients were randomly divided into three groups; conventional frenectomy operation (Group C), frenectomy operation using diode laser (Group L) and diode laser asissted frenectomy with horizontal incision on the periosteum (Group L+P). Postoperative pain, difficulty in speaking and eating scores were assessed postoperative 3 hours and 1, 7, 14, 21 and 45 days using Visual Analogue Scale (VAS). Evaluation of epithelialization of the wound surface was carried out via hydrogen peroxide to the surface using a dental injector at postoperative 7, 14, 21 and 45 days. Plaque index, gingival index, bleeding on probing and probing depth were assessed at baseline and postoperative 7, 14, 21 and 45 days. All data were compared between groups and within each group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Systemically healthy, nonsmoker, aged between 18 and 65, high papillary frenulum attachment diagnosed according to Mirko et al (Mirko et al, 1974), not received any periodontal treatment within the last 3 months, presence of at least central, lateral incisors and canines at the upper jaw, and consent to participate in the study.

Exclusion Criteria:

• Any systemic disease that might interfere with the prognosis of periodontal disease (i.e., diabetes mellitus, HIV infection), smoking, antibiotics, anti-inflammatory drugs or any other medication taken within the last 6 months that might affect the outcome of the study, any physical limitations or restrictions that might preclude normal oral hygiene procedures.

Related Conditions & MeSH terms

• Frenulum; Hypertrophy, Lip
• Hypertrophy

Intervention

Device:
• Gigaa Cheese 810 nm Diode Laser
Diode Laser assisted frenectomy operation.

Procedure:
• Conventional Frenectomy Operation
Frenectomy operation performed by surgical blades with suturing.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain Change	Postoperative pain during eating and speaking will be evaluate via visual analog scale (VAS).Visual Analogue Scale (VAS) was used to evaluate pain, discomfort during speaking and chewing. VAS consisted of a horizontal line with a range of numbers from '0' to '10' of which '0' means 'no pain' and '10' means unbearable pain.	Postoperative pain, difficulty during speaking and eating scores were assessed on postoperative 3 hours and 1, 7, 14, 21 and 45 days.