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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716154
Recruitment Status : Completed
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Jordan University of Science and Technology

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Periodontitis Radiation: Diode laser Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: split mouth
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Effectiveness of Diode Laser as an Adjunct in the Treatment of Periodontitis
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : April 30, 2018

Arm Intervention/treatment
Experimental: SRP and diode laser
In a split mouth design either left or right sites randomly treated by SRP and diode laser as an adjunct
Radiation: Diode laser
Diode laser 810nm, 2W, 20sec, 20 HZ

No Intervention: SRP alone
The other sites in the other side will be treated by SRP alone



Primary Outcome Measures :
  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 Outcome Measures:
  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);

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

    PI index score:

    0 = no plaque in the gingival area

    1. = 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.
    2. = 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.
    3. = abundance of soft matter within the gingival pocket and /or on the gingival margin and adjacent tooth surface.



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Ages Eligible for Study:   28 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03716154


Locations
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Jordan
ROLA
Irbid, Jordan
Sponsors and Collaborators
Jordan University of Science and Technology
Investigators
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Study Director: rola A alhabashneh, prof Jordan University of Science and Technology

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Responsible Party: Jordan University of Science and Technology
ClinicalTrials.gov Identifier: NCT03716154    
Other Study ID Numbers: JUSTShbool1
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases