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
About this trial
This is an interventional treatment trial for Chronic Periodontitis
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.
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
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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