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

NCT03412331 | Completed

• 1 other identifier: Borekci et al.
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Probing Depth

  defined as the distance from the free gingival margin to the bottom of the periodontal pocket

  63 day

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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; Device: Hand Instruments

Test Group

EXPERIMENTAL

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; Device: Hand Instruments; Device: LED Source

Interventions

Ultrasonic DEVICE

Cavitron® BOBCAT® Pro, Dentsply International, USA

Control Group; Test Group

Hand Instruments DEVICE

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

Control Group; Test Group

LED Source DEVICE

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

Test Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Leyla KURU, Prof. Dr.

  Marmara University, Faculty of Dentistry, Department of Periodontology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: January 26, 2018
• Study Start: January 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: September 1, 2012
• Last Updated: January 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share