Clinical Efficacy Of 810 Nanometer Diode Laser As An Adjunct To Mechanical Periodontal Treatment Of Residual Periodontal Pockets

Chronic Periodontitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531555
• Other study ID #: Meseli et al.
• Status: Completed
• Phase: N/A
• First received: August 6, 2015
• Last updated: August 21, 2015
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: August 2015
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Background: Aim of this randomized controlled parallel-designed study was to evaluate the effects of diode laser as an adjunct to mechanical periodontal treatment on clinical parameters and gingival crevicular fluid (GCF) volume of the residual pockets diagnosed following initial periodontal treatment in chronic periodontitis (CP) patients.

Methods: A total of 84 residual pockets on single-rooted teeth in 11 CP patients were included and randomly assigned into 3 groups. Residual pockets were treated either only by mechanical treatment (Group M) (n=28), only by diode laser disinfection (Group L) (n=28) or by combination of these techniques (Group M+L) (n=28). Plaque index, gingival index (GI), bleeding on probing (BoP), probing depth (PD), clinical attachment level and gingival recession were assessed at baseline and 8 weeks after treatment of residual pockets. GCF samples were collected at baseline, 1 and 8 weeks after treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

• Systemically healthy,

• Non-smoker,

• Chronic periodontitis diagnosed according to Armitage 1,

• Aged between 35 and 65,

• Not received any periodontal treatment within the last 3 months,

• Have horizontal bone loss radiographically,

• Presence at least 20 natural teeth except third molars

• 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 previous 6 months that may affect the outcome of the study,

• Any physical limitations or restrictions that might preclude normal oral hygiene procedures.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontal Pocket
• Periodontitis

Intervention

Device:
• 810 Nanometer Wavelenght GaAlAs Diode Laser
FDA approved 810 nanometer GaAlAs Diode Laser
• Gracey curettes

Locations

Country	Name	City	State
Turkey	Marmara University, Faculty of Dentistry	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing depth	Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.	8 week	Yes
Secondary	Plaque index		8 week	Yes
Secondary	Gingival index		8 week	Yes
Secondary	Clinical attachment level	Clinical attachment level is defined as the distance from the cementoenamel junction to the bottom of the periodontal pocket	8 week	Yes
Secondary	Bleeding on probing via periodontal probe	Bleeding on probing is defined as presence of bleeding from gingival sulcus during the probing of this area via periodontal probe.	8 week	Yes
Secondary	Change of gingival crevicular fluid volume	Gingival crevicular fluid is a blood-originated fluid playing important determinanat role in the ecology of the gingival sulcus and periodontal pocket	Baseline, 8 weeks	Yes