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

Study Overview
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Brief Summary
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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.

Official Title
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Clinical And Microbiological Evaluations Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis

Conditions
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Generalized Aggressive Periodontitis

Intervention / Treatment
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* Device: Ultrasonic
* Device: Hand Instruments
* Device: LED Source


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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. | Device: Ultrasonic<br>* Cavitron® BOBCAT® Pro, Dentsply International, USA<br>Device: Hand Instruments<br>* Gracey, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA<br>|
| Experimental: Test Group<br>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. | Device: Ultrasonic<br>* Cavitron® BOBCAT® Pro, Dentsply International, USA<br>Device: Hand Instruments<br>* Gracey, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA<br>Device: LED Source<br>* LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing Depth | defined as the distance from the free gingival margin to the bottom of the periodontal pocket | 63 day |