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Clinical Trials/NCT05655338
NCT05655338CompletedNot Applicable

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

University of Ljubljana0 sites20 target enrollmentStarted: January 10, 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Primary Endpoint
Bleeding on probing

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (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.

Eligibility Criteria

Ages
18 Years to 38 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • pregnancy
  • ingestion of systemic antibiotics within three months before therapy

Arms & Interventions

ANTIMICROBIAL PHOTODYNAMIC THERAPY

Experimental

The patients received antimicrobial photodynamic therapy after non-surgical periodontal treatment

Intervention: antimicrobial photodynamic therapy (Device)

SYSTEMIC ANTIBIOTICS

Experimental

The patients received systemic antibiotics after non-surgical periodontal treatment

Intervention: systemic antibiotics (Drug)

Outcomes

Primary Outcomes

Bleeding on probing

Time Frame: 3 months

Bleeding after measurement of probing depth

Probing depth reduction

Time Frame: 3 months

Change in probing depth

Secondary Outcomes

  • Clinical attachment loss(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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