- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03412331
Effects Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis
January 25, 2018 updated by: Marmara University
Clinical And Microbiological Evaluations Of Adjunctive Photodynamic Therapy To Non-Surgical Periodontal Treatment In Patients With Generalized Aggressive Periodontitis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Cavitron® BOBCAT® Pro, Dentsply International, USA
Gracey, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins.
Co., USA
|
Experimental: 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.
|
Cavitron® BOBCAT® Pro, Dentsply International, USA
Gracey, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins.
Co., USA
LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probing Depth
Time Frame: 63 day
|
defined as the distance from the free gingival margin to the bottom of the periodontal pocket
|
63 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Leyla KURU, Prof. Dr., Marmara University, Faculty of Dentistry, Department of Periodontology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2008
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
January 21, 2018
First Submitted That Met QC Criteria
January 25, 2018
First Posted (Actual)
January 26, 2018
Study Record Updates
Last Update Posted (Actual)
January 26, 2018
Last Update Submitted That Met QC Criteria
January 25, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Borekci et al.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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