NCT03308019

Adjunct Photodynamic Therapy in Chronic Periodontitis Among Cigarette-smokers.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: King Saud University · Academic / Other
• Sex: Male
• Age: 42 Years – 52 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Periodontitis
• Smoking

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-02-16
• Primary completion: 2017-07-02
• Completion: 2017-09-16
• First posted: 2017-10-12
• Last updated: 2017-10-12