Adjunct Photodynamic Therapy in Chronic Periodontitis Among Cigarette-smokers.

Not Applicable

Completed

• Conditions: Chronic Periodontitis; Smoking
• Interventions: Device: Photodynamic therapy; Procedure: Scaling and root planing (SRP)

• Registration Number: NCT03308019
• Lead Sponsor: King Saud University

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.

Study Timeline

• Study Start: 2016-02-16
• Primary Completion: 2017-07-02
• Study Completion: 2017-09-16
• Status Verified: 2017-10
• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-06
• Last Update Submitted: 2017-10-06
• Study First Posted: 2017-10-12
• Last Update Posted: 2017-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 83

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dental scaling	Scaling and root planing (SRP)	This arm will be given scaling and root planing (SRP) only
Adjunctive photodynamic therapy	Scaling and root planing (SRP)	This arm will be given scaling and root planing (SRP) with adjunctive photodynamic therapy (aPDT)
Adjunctive photodynamic therapy	Photodynamic therapy	This arm will be given scaling and root planing (SRP) with adjunctive photodynamic therapy (aPDT)
Dental scaling	Photodynamic therapy	This arm will be given scaling and root planing (SRP) only

Primary Outcome Measures

Name	Time	Method
Clinical attachment level gain	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.
Probing depth	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)

Secondary Outcome Measures

Name	Time	Method
Plaque index	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
Bleeding on probing	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