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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05655338
Other study ID # PHOTODYNAMICTHERAPY
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2015
Est. completion date June 30, 2016

Study information

Verified date December 2022
Source University of Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big challenge. The aim of the study was to compare the long-term results of antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical therapy in patients with aggressive periodontitis. Clinical parameters of probing depth, clinical attachment level and bleeding on probing (BOP) were assessed at baseline, 3, 6, 9 and 12 months after treatment.


Description:

Background: Treatment of aggressive periodontitis (stage III, grade C periodontitis) represents a big challenge. The aim of the study was to compare the long-term results of antimicrobial photodynamic therapy (aPDT) and antibiotic therapy as an adjunct to conventional non-surgical therapy in patients with aggressive periodontitis. Materials and methods: Twenty subjects with untreated aggressive periodontitis (stage III, grade C periodontitis) were divided into two groups: the test group (TG) received non-surgical therapy and two sessions of aPDT using a laser (HELBO TheraLite laser) with a wavelength of 670nm associated with HELBO Blue photosensitizer, and the control group (CG) received non-surgical therapy and antibiotics (amoxicillin 500mg and metronidazole 400mg, 7 days). Clinical parameters of probing depth, clinical attachment level and bleeding on probing (BOP) were assessed at baseline, 3, 6, 9 and 12 months after treatment.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 30, 2016
Est. primary completion date June 30, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 38 Years
Eligibility Inclusion Criteria: - aggressive periodontitis (stage III, grade C periodontitis) - nonsmokers - at least 20 teeth in oral cavity - systemically healthy Exclusion Criteria: - any previous periodontal treatment - smoking - pregnancy - ingestion of systemic antibiotics within three months before therapy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
antimicrobial photodynamic therapy

Drug:
systemic antibiotics


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Ljubljana

Outcome

Type Measure Description Time frame Safety issue
Primary Probing depth reduction Change in probing depth 3 months
Primary Bleeding on probing Bleeding after measurement of probing depth 3 months
Secondary Clinical attachment loss Change in clinical attachment 3 months
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