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

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

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.

Study Overview

• Status: Completed
• Conditions: Aggressive Periodontitis
• Intervention / Treatment: Device: antimicrobial photodynamic therapy; Drug: systemic antibiotics

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 34 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ANTIMICROBIAL PHOTODYNAMIC THERAPY; The patients received antimicrobial photodynamic therapy after non-surgical periodontal treatment	Device: antimicrobial photodynamic therapy; Other Names: HELBO TheraLite Laser
Experimental: SYSTEMIC ANTIBIOTICS; The patients received systemic antibiotics after non-surgical periodontal treatment	Drug: systemic antibiotics; Other Names: Amoxicillin (Hiconcil); Metronidazole (Efloran)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing depth reduction	Change in probing depth	3 months
Bleeding on probing	Bleeding after measurement of probing depth	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment loss	Change in clinical attachment	3 months

Collaborators and Investigators

• Sponsor: University of Ljubljana
• Investigators: Study Chair: Boris Gaspirc, Assoc.prof., University of Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2015
• Primary Completion (Actual): June 30, 2016
• Study Completion (Actual): June 30, 2016

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Photodynamic therapy; Antibiotic therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Aggression; Periodontitis; Aggressive Periodontitis; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole; Anti-Bacterial Agents; Amoxicillin; Anti-Infective Agents
• Other Study ID Numbers: PHOTODYNAMICTHERAPY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No