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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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ClinicalTrials.gov Identifier: NCT02531555
Recruitment Status : Completed
First Posted : August 24, 2015
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Marmara University

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.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis Device: 810 Nanometer Wavelenght GaAlAs Diode Laser Device: Gracey curettes Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

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 Name: 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 Name: 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: 810 Nanometer Wavelenght GaAlAs Diode Laser
FDA approved 810 nanometer GaAlAs Diode Laser
Other Name: CHEESE®, Gigaa Laser, China

Device: Gracey curettes
Other Name: Hu-Friedy, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Plaque index [ Time Frame: 8 week ]
  2. Gingival index [ Time Frame: 8 week ]
  3. 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

  4. 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.

  5. 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



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531555


Locations
Turkey
Marmara University, Faculty of Dentistry
Istanbul, Turkey
Sponsors and Collaborators
Marmara University

Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT02531555     History of Changes
Other Study ID Numbers: Meseli et al.
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: August 24, 2015
Last Verified: August 2015

Keywords provided by Marmara University:
chronic periodontitis
dental scaling
gingival crevicular fluid
lasers
periodontal pocket
root planing

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Pocket
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases