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

Generalized Aggressive Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412331
• Other study ID #: Borekci et al.
• Status: Completed
• Phase: N/A
• First received: January 21, 2018
• Last updated: January 25, 2018
• Start date: January 2008
• Est. completion date: September 2012

Study information

• Verified date: January 2018
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Aggressive Periodontitis
• Generalized Aggressive Periodontitis
• Periodontitis

Intervention

Device:
• Ultrasonic
Cavitron® BOBCAT® Pro, Dentsply International, USA
• Hand Instruments
Gracey, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA
• LED Source
LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing Depth	defined as the distance from the free gingival margin to the bottom of the periodontal pocket	63 day