Antimicrobial Photodynamic Therapy in Patients With Periodontal Disease and Type 2 Diabetes Mellitus

University of Ljubljana

Status: Completed

Conditions: Periodontitis; Periodontal Attachment Loss; Periodontal Pocket; Periodontal Diseases; Diabetes Mellitus, Type 2; Periodontal Inflammation

Treatments: Procedure: Conventional Periodontal Treatment (Complete Oral Disinfection); Procedure: Adjunctive Photodynamic Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05816941

aPTD in Pariodontal Treatment

Details and patient eligibility

About

Objectives: This study aimed to determine the effect of concomitant antimicrobial photodynamic therapy (aPTD) on periodontal disease and glycaemic control in patients with type 2 diabetes mellitus (T2DM).

Clinical Relevance: aPTD is a noninvasive adjunctive therapy that can positively influence the periodontal treatment outcome.

Full description

Numerous studies confirm that diabetes mellitus increases the risk of gingivitis and periodontitis. However, periodontal disease also impairs glycaemic control in people with diabetes mellitus via inflammatory mediators.

Methods:

Twenty-four patients with T2DM were enrolled in the study. Periodontal tissue status and periodontal disease were assessed by measuring probing pocket depth (PPD), bleeding on probing (BOP), clinical attachment loss (CAL), plaque index (PI) and sulcus bleeding index (SBI). Glycated haemoglobin A1c (HbA1c) was measured. To determine the presence of the following periodontal pathogenic bacteria Aggregatibacter actinomycetemcomitans, Prevotella intermedia, Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola, subgingival plaque samples were taken from two periodontal pockets with the greatest PPD using paper tips. Patients were randomly divided into the test and control group. In the test group, complete oral disinfection was performed in combination with aPTD. In the control group, only complete oral disinfection was performed.

Enrollment: 24 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 40 and 75 years
• Diabetes Mellitus type 2 with an HbA1c value > 7.0%,
• At least ten teeth in the Maxilla and Mandible
• At least four teeth with a probing pocket depth ≥ 5 mm and bleeding on probing.

Exclusion criteria

• Antibiotic treatment in the last four months
• Periodontal treatment in the last six months
• Any change in Antihyperglycaemic treatment three months prior to participation
• Pregnant women
• Lactating women
• Smokers
• Former smokers who had stopped smoking less than five years before participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Control Arm

Other group

Description:

Conventional Periodontal Treatment: Complete Oral Disinfection.

Treatment:

Procedure: Conventional Periodontal Treatment (Complete Oral Disinfection)

Experimental Arm

Experimental group

Description:

Conventional Periodontal Treatment (Complete Oral Disinfection) and Adjunctive Photodynamic Therapy in periodontal pockets with PPD ≥ 5 mm.

Treatment:

Procedure: Adjunctive Photodynamic Therapy

Procedure: Conventional Periodontal Treatment (Complete Oral Disinfection)