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

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
810 Nanometer Wavelenght GaAlAs Diode Laser
Gracey curettes
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring chronic periodontitis, dental scaling, gingival crevicular fluid, lasers, periodontal pocket, root planing

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Marmara University, Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Group M

Group L

Group M+L

Arm Description

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.

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.

Combined treatment (Group M+L): Following mechanical periodontal treatment, pocket irradiation with diode laser was performed as mentioned above.

Outcomes

Primary Outcome Measures

Probing depth
Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.

Secondary Outcome Measures

Plaque index
Gingival index
Clinical attachment level
Clinical attachment level is defined as the distance from the cementoenamel junction to the bottom of the periodontal pocket
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.
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

Full Information

First Posted
August 6, 2015
Last Updated
August 21, 2015
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT02531555
Brief Title
Clinical Efficacy Of 810 Nanometer Diode Laser As An Adjunct To Mechanical Periodontal Treatment Of Residual Periodontal Pockets
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
chronic periodontitis, dental scaling, gingival crevicular fluid, lasers, periodontal pocket, root planing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group M
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group L
Arm Type
Experimental
Arm Description
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.
Arm Title
Group M+L
Arm Type
Experimental
Arm Description
Combined treatment (Group M+L): Following mechanical periodontal treatment, pocket irradiation with diode laser was performed as mentioned above.
Intervention Type
Device
Intervention Name(s)
810 Nanometer Wavelenght GaAlAs Diode Laser
Other Intervention Name(s)
CHEESE®, Gigaa Laser, China
Intervention Description
FDA approved 810 nanometer GaAlAs Diode Laser
Intervention Type
Device
Intervention Name(s)
Gracey curettes
Other Intervention Name(s)
Hu-Friedy, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA
Primary Outcome Measure Information:
Title
Probing depth
Description
Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Plaque index
Time Frame
8 week
Title
Gingival index
Time Frame
8 week
Title
Clinical attachment level
Description
Clinical attachment level is defined as the distance from the cementoenamel junction to the bottom of the periodontal pocket
Time Frame
8 week
Title
Bleeding on probing via periodontal probe
Description
Bleeding on probing is defined as presence of bleeding from gingival sulcus during the probing of this area via periodontal probe.
Time Frame
8 week
Title
Change of gingival crevicular fluid volume
Description
Gingival crevicular fluid is a blood-originated fluid playing important determinanat role in the ecology of the gingival sulcus and periodontal pocket
Time Frame
Baseline, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Marmara University, Faculty of Dentistry
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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

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