Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis (Stage III, Grade C Periodontitis)

NCT05655338 | Completed

• 1 other identifier: PHOTODYNAMICTHERAPY
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aggressive Periodontitis

Keywords

Photodynamic therapy; Antibiotic therapy

Outcome Measures

Primary Outcomes (2)

• Probing depth reduction

  Change in probing depth

  3 months

• Bleeding on probing

  Bleeding after measurement of probing depth

  3 months

Secondary Outcomes (1)

• Clinical attachment loss

  3 months

Study Arms (2)

ANTIMICROBIAL PHOTODYNAMIC THERAPY

EXPERIMENTAL

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

Device: antimicrobial photodynamic therapy

SYSTEMIC ANTIBIOTICS

EXPERIMENTAL

The patients received systemic antibiotics after non-surgical periodontal treatment

Drug: systemic antibiotics

Interventions

antimicrobial photodynamic therapy DEVICE

Also known as: HELBO TheraLite Laser

ANTIMICROBIAL PHOTODYNAMIC THERAPY

systemic antibiotics DRUG

Also known as: Amoxicillin (Hiconcil), Metronidazole (Efloran)

SYSTEMIC ANTIBIOTICS

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• aggressive periodontitis (stage III, grade C periodontitis)
• nonsmokers
• at least 20 teeth in oral cavity
• systemically healthy

You may not qualify if:

• any previous periodontal treatment
• smoking
• pregnancy
• ingestion of systemic antibiotics within three months before therapy

Sponsors & Collaborators

• University of Ljubljana: lead

MeSH Terms

Conditions

Aggressive Periodontitis

Interventions

Amoxicillin; Metronidazole

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Boris Gaspirc, Assoc.prof.

  University of Ljubljana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 19, 2022
• Study Start: January 10, 2015
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share