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

August 21, 2015 updated by: Marmara University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

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
      • Istanbul, Turkey
        • Marmara University, Faculty of Dentistry

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

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group M
Mechanical periodontal treatment (Group M): Scaling and root planing were performed with Gracey curettes until the operator feels that root surface is clean, hard and smooth.
Device: Gracey curettes
Other Names:
  • Hu-Friedy, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA
Experimental: Group L
Pocket disinfection with diode laser (Group L): Subgingival irradiation with a GaAlAs diode laser (CHEESE®, Gigaa Laser, China) was applied to residual pockets each for 20 sec in continious mode. The diode laser had a wavelenght of 810 nm and power output of 1 W for subgingival irradiation (Maximum output power of device was 7 W). Diode laser application was performed parallel to root surface by a 200 µm fiber tip inserted at the bottom of periodontal pocket and slowly moved from apical to coronal direction in a sweeping motion without local anesthesia.
Device: 810 Nanometer Wavelenght GaAlAs Diode Laser
FDA approved 810 nanometer GaAlAs Diode Laser
Other Names:
  • CHEESE®, Gigaa Laser, China
Experimental: Group M+L
Combined treatment (Group M+L): Following mechanical periodontal treatment, pocket irradiation with diode laser was performed as mentioned above.
Device: Gracey curettes
Other Names:
  • Hu-Friedy, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA
Device: 810 Nanometer Wavelenght GaAlAs Diode Laser
FDA approved 810 nanometer GaAlAs Diode Laser
Other Names:
  • CHEESE®, Gigaa Laser, China

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth
Time Frame: 8 week
Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.
8 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical attachment level
Time Frame: 8 week
Clinical attachment level is defined as the distance from the cementoenamel junction to the bottom of the periodontal pocket
8 week
Plaque index
Time Frame: 8 week
8 week
Gingival index
Time Frame: 8 week
8 week
Bleeding on probing via periodontal probe
Time Frame: 8 week
Bleeding on probing is defined as presence of bleeding from gingival sulcus during the probing of this area via periodontal probe.
8 week
Change of gingival crevicular fluid volume
Time Frame: Baseline, 8 weeks
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

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

January 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

August 21, 2015

First Posted (Estimate)

August 24, 2015

Study Record Updates

Last Update Posted (Estimate)

August 24, 2015

Last Update Submitted That Met QC Criteria

August 21, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Meseli et al.

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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