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Completed

NCT Number: NCT03716154

Clinical Effectiveness of Diode Laser as an Adjunct in the Treatment of Periodontitis

a randomized controlled single-blinded study. the hypothesis of this clinical trial is that disjunctive use of diode laser improve the clinical parameters of periodontists , and there are significant difference between the conventional treatment and diode laser as an adjunct

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

28 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ROLA

Irbid, Jordan

About this study

A total of 240 sites with deep pocket in 30 systemically healthy patients with chronic periodontitis, from subjects attending Jordan University of Science and Technology (JUST) Postgraduate Dental Clinic (PDC), the age range were (28-55) year, between Apr 2017 and Oct 2017. Those patients were enrolled in a randomized controlled single-blinded study. For each patient, full medical and dental history and periodontal examination were recorded. Clinical parameters such as pocket depth (PD), clinical attachment loss (CAL), gingival index (GI) and plaque index (PI) were evaluated at the baseline. All Patients underwent initial periodontal therapy; SRP which was performed using a sonic device and hand instruments and the sites were divided randomly into two groups SRP alone and SRP with adjunctive diode 810 nm laser in the contralateral sites in the same jaw. The Clinical parameters have been re-evaluated at 1, 3 and 6 months to test the effectiveness of (810 nm, 2 W, pulsed mode, for 20 sec) in treatment of CP. Diode laser therapy was applied to periodontal pockets in the same day of treatment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy patients having periodontitis in at least two quadrants each quadrant should have at least 4 sites with PD >4mm.
  • Both male and female patients.
  • Patient who are ready to cooperate with diode laser treatment.
  • Patient who can comply with 3 visits for follow up (three times).

Exclusion criteria

  • Subjects with systemic diseases that may interfere with wound healing (such as diabetes) or any systemic disease that complicates the treatment.
  • Pregnant women and breast feeding.
  • Smokers, alcohol or drug dependent.
  • Patients who received any form of periodontal treatment within the last 6 months.
  • Patients who are currently taking or were on antibiotic treatment within the last 6 months.
  • Presence of faulty restoration at teeth involved in the disease.
  • Teeth indicated for extraction at sites that will be part of the study.
  • Patient under 18 years of age.

Treatment and study plan

Diode laser

Radiation

Diode laser 810nm, 2W, 20sec, 20 HZ

Primary outcomes

  1. Probing depth (PD) in millimeter (mm), clinical attachment loss (CAL) in millimeter (mm)

    Time frame: Change from baseline to 1 month in PD and CAL, change from baseline to 3 month in PD and CAL ,change from baseline to 6 month in PD and CAL

    PD its the distance from gingival margin to the base of the pocket in millimeter (mm) CAL the recession is added to the PD in millimeter (mm)

Other outcomes

  1. GI index score ,PI index score

    Time frame: Change from baseline in GI and PI at 1 month, change from baseline in GI and PI at 3 month, Change from baseline in GI and PI at 6 month

    GI index score:

    0 = normal gingiva (pink, scalloped margin, pin pointed papilla, thin buccal and lingual margin);

    • = mild inflammation (slight changes in color, slight edema, no bleeding on probing);
    • = moderate inflammation (redness, edema, bleeding on probing)
    • = severe inflammation (marked redness, edema, ulceration, spontaneous bleeding).

    PI index score:

    0 = no plaque in the gingival area

    • = a film of plaque adhering to the gingival margin and adjacent area of the tooth. The plaque may be only recognized by running a probe across the tooth surface.
    • = moderate accumulation of soft debris within the gingival pocket on the gingival and/or on the tooth surface, which can be seen by naked eye.
    • = abundance of soft matter within the gingival pocket and /or on the gingival margin and adjacent tooth surface.

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 23, 2018
Registry last updated
Oct 23, 2018

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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