Adjunct Photodynamic Therapy in Chronic Periodontitis Among Cigarette-smokers.

• ClinicalTrials.gov Identifier: NCT03308019
• Recruitment Status: Completed
• First Posted: October 12, 2017
• Last Update Posted: October 12, 2017
• Sponsor: King Saud University
• Information provided by (Responsible Party): Zohaib Akram, King Saud University

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.

Condition or disease	Intervention/treatment	Phase
Chronic Periodontitis; Smoking	Device: Photodynamic therapy; Procedure: Scaling and root planing (SRP)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 16, 2016
• Actual Primary Completion Date: July 2, 2017
• Actual Study Completion Date: September 16, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Adjunctive photodynamic therapy; This arm will be given scaling and root planing (SRP) with adjunctive photodynamic therapy (aPDT)	Device: Photodynamic therapy; 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.; Procedure: Scaling and root planing (SRP); 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.
Active Comparator: Dental scaling; This arm will be given scaling and root planing (SRP) only	Device: Photodynamic therapy; 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.; Procedure: Scaling and root planing (SRP); 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.

Outcome Measures

Primary Outcome Measures :

1. Probing depth [ Time Frame: 3 months ]
   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)
2. Clinical attachment level gain [ Time Frame: 3 months ]
   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 :

1. Plaque index [ Time Frame: 3 months ]

   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

2. Bleeding on probing [ Time Frame: 3 months ]

   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

Eligibility Criteria

• Ages Eligible for Study: 42 Years to 52 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Zohaib Akram, Director, Clinical Research, King Saud University
• ClinicalTrials.gov Identifier: NCT03308019
• Other Study ID Numbers: FR-17-87
• First Posted: October 12, 2017
• Last Update Posted: October 12, 2017
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified individual participant data for all primary outcome measures will be made available
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: Data is available

• 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

Additional relevant MeSH terms:

Periodontitis; Chronic Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases