Effects Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis

Not Applicable

Completed

• Conditions: Generalized Aggressive Periodontitis
• Interventions: Device: Ultrasonic; Device: Hand Instruments; Device: LED Source

• Registration Number: NCT03412331
• Lead Sponsor: Marmara University

Brief Summary

Generalized aggressive periodontitis (GAgP) is a distinct type of periodontal disease characterized by rapid loss of attachment and alveolar bone occuring in young individuals. Photodynamic therapy (PDT) was introduced in periodontology as an adjunctive approach to non-surgical periodontal treatment (NPT) in periodontitis patients. In this trial, it was aimed that to evaluate the clinical and microbiological effects of adjunctive PDT to NPT in patients with GAgP. In this prospective controlled clinical study, 24 systemically healthy, non-smoking subjects with GAgP were enrolled. Subjects were randomly assigned to a control group (n=12) treated with NPT only or to a test group (n=12) treated with NPT and PDT. Plaque index, sulcus bleeding index (SBI), pocket depth (PD), relative attachment level, gingival recession, mobility were recorded at baseline and on day 63. Microbiological samples were obtained fom the sites with PD ≥5 mm at the same time points and evaluated for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia and Treponema denticola using micro-IDent test.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2011-01
• Study Completion: 2012-09
• Status Verified: 2018-01
• Study First Submitted: 2018-01-21
• Study First Submitted QC: 2018-01-25
• Last Update Submitted: 2018-01-25
• Study First Posted: 2018-01-26
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• systemically healthy,
• non-smoker
• not received any periodontal treatment within the last 6 months
• no antibiotics, anti-inflammatory drugs or any other medication taken within the last 6 months
• consent to participate in the study

Exclusion Criteria

• any systemic disease (i.e. diabetes mellitus, HIV infection) that might influence the prognosis of periodontal disease and outcome of the treatment
• any medical condition that required antibiotic prophylaxis before the treatment
• smoking
• pregnancy and lactation
• ingestion of antibiotics, anti-inflammatory drugs or any other medication during study period
• any physical limitations or restrictions that might preclude normal oral hygiene procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Ultrasonic	NPT including scaling and root planing was applied to 12 subjects with ultrasonic and hand instruments until the operator feels that root surface is clean, hard and smooth.
Test Group	Hand Instruments	Following NPT, toluidine blue O mediated PDT was performed with a LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark) to 12 subjects. The dye (0.1 mg/ml) was applied with a canula into the periodontal pockets. After 3 minutes, the subjects rinsed their mouths with sterile saline solution for removal of excessive dye. Then, the applicator of photosensitizer was inserted until the bottom of the periodontal pocket and photoinactivation was performed in 6 sites per tooth for 10 seconds of each sites with a total of 60 seconds per tooth.
Control Group	Hand Instruments	NPT including scaling and root planing was applied to 12 subjects with ultrasonic and hand instruments until the operator feels that root surface is clean, hard and smooth.
Test Group	Ultrasonic	Following NPT, toluidine blue O mediated PDT was performed with a LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark) to 12 subjects. The dye (0.1 mg/ml) was applied with a canula into the periodontal pockets. After 3 minutes, the subjects rinsed their mouths with sterile saline solution for removal of excessive dye. Then, the applicator of photosensitizer was inserted until the bottom of the periodontal pocket and photoinactivation was performed in 6 sites per tooth for 10 seconds of each sites with a total of 60 seconds per tooth.
Test Group	LED Source	Following NPT, toluidine blue O mediated PDT was performed with a LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark) to 12 subjects. The dye (0.1 mg/ml) was applied with a canula into the periodontal pockets. After 3 minutes, the subjects rinsed their mouths with sterile saline solution for removal of excessive dye. Then, the applicator of photosensitizer was inserted until the bottom of the periodontal pocket and photoinactivation was performed in 6 sites per tooth for 10 seconds of each sites with a total of 60 seconds per tooth.

Primary Outcome Measures

Name	Time	Method
Probing Depth	63 day	defined as the distance from the free gingival margin to the bottom of the periodontal pocket