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Completed

NCT Number: NCT02531555

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

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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontal Pocket Periodontitis Stomatognathic Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University, Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

810 Nanometer Wavelenght GaAlAs Diode Laser

Device

FDA approved 810 nanometer GaAlAs Diode Laser

Other names: CHEESE®, Gigaa Laser, China

Gracey curettes

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 24, 2015
Registry last updated
Aug 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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