Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis)
Primary Purpose
Aggressive Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
antimicrobial photodynamic therapy
systemic antibiotics
Sponsored by
About this trial
This is an interventional treatment trial for Aggressive Periodontitis focused on measuring Photodynamic therapy, Antibiotic therapy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ANTIMICROBIAL PHOTODYNAMIC THERAPY
SYSTEMIC ANTIBIOTICS
Arm Description
The patients received antimicrobial photodynamic therapy after non-surgical periodontal treatment
The patients received systemic antibiotics after non-surgical periodontal treatment
Outcomes
Primary Outcome Measures
Probing depth reduction
Change in probing depth
Bleeding on probing
Bleeding after measurement of probing depth
Secondary Outcome Measures
Clinical attachment loss
Change in clinical attachment
Full Information
NCT ID
NCT05655338
First Posted
November 23, 2022
Last Updated
December 8, 2022
Sponsor
University of Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT05655338
Brief Title
Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis)
Official Title
Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis): A Comparison Between Photodynamic Therapy and Antibiotic Therapy as an Adjunct to Non-Surgical Periodontal Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2015 (Actual)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
June 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ljubljana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggressive Periodontitis
Keywords
Photodynamic therapy, Antibiotic therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
The blindness of the examiner was ensured by restriction of access to the patients' data. Only the supervisor (MP) had access to the allocation data and therefore knew which patients received additional aPDT treatment.
Periodontal examinations of 5 randomly selected individuals were carried out twice by the same examiner, and the second measurements were repeated after two weeks. The reproducibility of assessing all periodontal parameters was tested. Intra-examiner calibration scores were 0.95.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ANTIMICROBIAL PHOTODYNAMIC THERAPY
Arm Type
Experimental
Arm Description
The patients received antimicrobial photodynamic therapy after non-surgical periodontal treatment
Arm Title
SYSTEMIC ANTIBIOTICS
Arm Type
Experimental
Arm Description
The patients received systemic antibiotics after non-surgical periodontal treatment
Intervention Type
Device
Intervention Name(s)
antimicrobial photodynamic therapy
Other Intervention Name(s)
HELBO TheraLite Laser
Intervention Type
Drug
Intervention Name(s)
systemic antibiotics
Other Intervention Name(s)
Amoxicillin (Hiconcil), Metronidazole (Efloran)
Primary Outcome Measure Information:
Title
Probing depth reduction
Description
Change in probing depth
Time Frame
3 months
Title
Bleeding on probing
Description
Bleeding after measurement of probing depth
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Clinical attachment loss
Description
Change in clinical attachment
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Gaspirc, Assoc.prof.
Organizational Affiliation
University of Ljubljana
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis)
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