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

NCT ID: NCT03412331

Last Updated: 2018-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-09-30

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.

Conditions

Generalized Aggressive Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Ultrasonic

Intervention Type: DEVICE

Cavitron® BOBCAT® Pro, Dentsply International, USA

Hand Instruments

Intervention Type: DEVICE

Gracey, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA

Test Group

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.

Group Type: EXPERIMENTAL

Ultrasonic

Intervention Type: DEVICE

Cavitron® BOBCAT® Pro, Dentsply International, USA

Hand Instruments

Intervention Type: DEVICE

Gracey, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA

LED Source

Intervention Type: DEVICE

LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark)

Interventions

Ultrasonic

Cavitron® BOBCAT® Pro, Dentsply International, USA

Intervention Type: DEVICE

Hand Instruments

Gracey, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA

Intervention Type: DEVICE

LED Source

LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leyla KURU, Prof. Dr.

Role: STUDY_DIRECTOR

Marmara University, Faculty of Dentistry, Department of Periodontology

Other Identifiers

Borekci et al.

Identifier Type: -

Identifier Source: org_study_id