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

NCT ID: NCT05655338

Last Updated: 2022-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-10

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Aggressive Periodontitis

Keywords

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Photodynamic therapy Antibiotic therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers
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.

Study Groups

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ANTIMICROBIAL PHOTODYNAMIC THERAPY

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

Group Type EXPERIMENTAL

antimicrobial photodynamic therapy

Intervention Type DEVICE

SYSTEMIC ANTIBIOTICS

The patients received systemic antibiotics after non-surgical periodontal treatment

Group Type EXPERIMENTAL

systemic antibiotics

Intervention Type DRUG

Interventions

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antimicrobial photodynamic therapy

Intervention Type DEVICE

systemic antibiotics

Intervention Type DRUG

Other Intervention Names

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HELBO TheraLite Laser Amoxicillin (Hiconcil) Metronidazole (Efloran)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boris Gaspirc, Assoc.prof.

Role: STUDY_CHAIR

University of Ljubljana

Other Identifiers

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PHOTODYNAMICTHERAPY

Identifier Type: -

Identifier Source: org_study_id