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Adjunct Photodynamic Therapy in Chronic Periodontitis Among Cigarette-smokers.

Primary Purpose

Chronic Periodontitis, Smoking

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Photodynamic therapy
Scaling and root planing (SRP)
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

42 Years - 52 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Self-reported habitual cigarette-smokers.
  • Self-reported never-smokers.
  • Patients with chronic periodontitis (presence of at least 30% sites with ≥ 3 mm of CAL and PD ≥ 3 mm.

Exclusion Criteria:

  • Patients with systemic diseases such as acquired immune deficiency syndrome/HIV and diabetes mellitus.
  • Habitual smokeless tobacco product and alcohol users.
  • Third molars and fractured teeth with embedded root remnants and edentulous individuals.
  • Patients with misaligned teeth.
  • Patients that reported to have used antibiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 90 days.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Adjunctive photodynamic therapy

    Dental scaling

    Arm Description

    This arm will be given scaling and root planing (SRP) with adjunctive photodynamic therapy (aPDT)

    This arm will be given scaling and root planing (SRP) only

    Outcomes

    Primary Outcome Measures

    Probing depth
    Probing depth will be measured as the distance from the gingival margin to the location of the tip of the probe to the nearest millimeter. Pocket depth assessment was carried out at 6 sites per tooth for all teeth (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual)
    Clinical attachment level gain
    Clinical attachment level gain will be calculated for each site as the sum of probing depth and gingival recession. The CAL was recorded at 6 sites per tooth for all teeth (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual) except third molars.

    Secondary Outcome Measures

    Plaque index
    Plaque index will be detected visually by running the probe at 4 sites per tooth (mesio-buccal, disto-buccal, mid-buccal and palatal/lingual) for absence or presence of plaque, based on dichotomous scoring system. The scores ranged as follows; 0 - No visible plaque 1 - Visible plaque
    Bleeding on probing
    Bleeding on probing will be recorded at 4 sites per tooth (mesio-buccal, disto-buccal, mid-buccal, and palatal/lingual) for absence or presence of bleeding, based on dichotomous scoring system. The scores ranged as follows; 0 - No visible bleeding 1 - Visible bleeding

    Full Information

    First Posted
    October 3, 2017
    Last Updated
    October 6, 2017
    Sponsor
    King Saud University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03308019
    Brief Title
    Adjunct Photodynamic Therapy in Chronic Periodontitis Among Cigarette-smokers.
    Official Title
    Effectiveness of Scaling and Root Planing With and Without Adjunct Antimicrobial Photodynamic Therapy in the Treatment of Chronic Periodontitis Among Cigarette-smokers and Never-smokers: A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 16, 2016 (Actual)
    Primary Completion Date
    July 2, 2017 (Actual)
    Study Completion Date
    September 16, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    King Saud University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    This study evaluates the efficacy of scaling and root planing with and without adjunct antimicrobial photodynamic therapy (aPDT) in the treatment of chronic periodontitis (CP) among cigarette-smokers and never-smokers.
    Detailed Description
    The following inclusion criteria were entailed: (a) Self-reported habitual cigarette-smokers; (b) self-reported never-smokers; (c) patients with CP (presence of at least 30% sites with ≥ 3 mm of CAL and PD ≥ 3 mm 18, 19 ). The exclusion criteria were as follows: (a) patients with systemic diseases such as acquired immune deficiency syndrome/HIV and diabetes mellitus; (b) habitual smokeless tobacco product and alcohol users; (c) third molars and fractured teeth with embedded root remnants and edentulous individuals; (d) patients with misaligned teeth; and (e) patients that reported to have used antibiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 90 days. Demographic information was collected using a questionnaire. Cigarette-smokers (group-1) and never-smokers (group-2) with chronic periodontitis were included. Treatment wise, these individuals were divided into two subgroups as follows: (a) SRP alone and (b) SRP with adjunct aPDT. Periodontal parameters (plaque index [PI], bleeding on probing [BOP], clinical attachment loss [CAL] and probing pocket depth ≥4mm [PD] were measured at baseline and at 1 month and 3 months' follow-up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis, Smoking

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    83 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Adjunctive photodynamic therapy
    Arm Type
    Experimental
    Arm Description
    This arm will be given scaling and root planing (SRP) with adjunctive photodynamic therapy (aPDT)
    Arm Title
    Dental scaling
    Arm Type
    Active Comparator
    Arm Description
    This arm will be given scaling and root planing (SRP) only
    Intervention Type
    Device
    Intervention Name(s)
    Photodynamic therapy
    Intervention Description
    In groups 1 and 2, aPDT was performed after SRP. The protocol for aPDT is described elsewhere. Briefly, using a blunt needle, 0.005% of Methylene blue was applied into the periodontal pocket and left in place for 10 seconds. The dye was then irradiated with a diode laser (670 nanometers) at 150 milliwatts. In each dye filled periodontal pocket, laser irradiation was performed for one minute using a flexible tip. In the present study, aPDT was performed once, at baseline, by a trained dentist.
    Intervention Type
    Procedure
    Intervention Name(s)
    Scaling and root planing (SRP)
    Intervention Description
    In both groups, SRP was performed in one session under local anesthesia using handheld Gracey curettes No. 5/6. One trained dental hygienist blinded to the study groups and subgroups made 9 to 10 strokes in a vertical (apico-coronal) direction and the inclination between scaler tips and roots was maintained as zero. When the curved explorer indicated a smooth and hard dental surface, SRP was judged as completed. In all individuals, SRP was done in one session without any assigned time limit for completion.
    Primary Outcome Measure Information:
    Title
    Probing depth
    Description
    Probing depth will be measured as the distance from the gingival margin to the location of the tip of the probe to the nearest millimeter. Pocket depth assessment was carried out at 6 sites per tooth for all teeth (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual)
    Time Frame
    3 months
    Title
    Clinical attachment level gain
    Description
    Clinical attachment level gain will be calculated for each site as the sum of probing depth and gingival recession. The CAL was recorded at 6 sites per tooth for all teeth (disto-buccal, mid-buccal, mesio-buccal, mesio-lingual, mid-lingual and disto-lingual) except third molars.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Plaque index
    Description
    Plaque index will be detected visually by running the probe at 4 sites per tooth (mesio-buccal, disto-buccal, mid-buccal and palatal/lingual) for absence or presence of plaque, based on dichotomous scoring system. The scores ranged as follows; 0 - No visible plaque 1 - Visible plaque
    Time Frame
    3 months
    Title
    Bleeding on probing
    Description
    Bleeding on probing will be recorded at 4 sites per tooth (mesio-buccal, disto-buccal, mid-buccal, and palatal/lingual) for absence or presence of bleeding, based on dichotomous scoring system. The scores ranged as follows; 0 - No visible bleeding 1 - Visible bleeding
    Time Frame
    3 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    42 Years
    Maximum Age & Unit of Time
    52 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Self-reported habitual cigarette-smokers. Self-reported never-smokers. Patients with chronic periodontitis (presence of at least 30% sites with ≥ 3 mm of CAL and PD ≥ 3 mm. Exclusion Criteria: Patients with systemic diseases such as acquired immune deficiency syndrome/HIV and diabetes mellitus. Habitual smokeless tobacco product and alcohol users. Third molars and fractured teeth with embedded root remnants and edentulous individuals. Patients with misaligned teeth. Patients that reported to have used antibiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 90 days.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified individual participant data for all primary outcome measures will be made available
    IPD Sharing Time Frame
    Data is available

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    Adjunct Photodynamic Therapy in Chronic Periodontitis Among Cigarette-smokers.

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