Antimicrobial Photodynamic Therapy in Patients With Periodontal Disease and Type 2 Diabetes Mellitus
- Conditions
- Periodontal PocketPeriodontal DiseasesPeriodontal Attachment LossPeriodontitisPeriodontal InflammationDiabetes Mellitus, Type 2
- Interventions
- Procedure: Conventional Periodontal Treatment (Complete Oral Disinfection)Procedure: Adjunctive Photodynamic Therapy
- Registration Number
- NCT05816941
- Lead Sponsor
- University of Ljubljana
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Arm Adjunctive Photodynamic Therapy Conventional Periodontal Treatment (Complete Oral Disinfection) and Adjunctive Photodynamic Therapy in periodontal pockets with PPD ≥ 5 mm. Control Arm Conventional Periodontal Treatment (Complete Oral Disinfection) Conventional Periodontal Treatment: Complete Oral Disinfection. Experimental Arm Conventional Periodontal Treatment (Complete Oral Disinfection) Conventional Periodontal Treatment (Complete Oral Disinfection) and Adjunctive Photodynamic Therapy in periodontal pockets with PPD ≥ 5 mm.
- Primary Outcome Measures
Name Time Method Bleeding on probing (BOP) 90 days after treatment Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)
The presence of five periodontal pathogens, Aggregatibacter actinomycetemcomitans (AA), Porphyromonas gingivalis (PG), Prevotella intermedia (PI), Tanerella forsythia (TF) and Treponema denticola (TD), 90 days after treatment Plaque samples were collected with sterile paper tips after supragingival soft and hard debris had been removed according to the manufacturer's instructions. Analysis by Polymerase chain reaction (PCR) followed by hybridization against species-specific DNA probes. According to the manufacturer, the cut-off of the test is set at 10³ to 10⁴ genome equivalents
Probing pocket depth (PPD) 90 days after treatment Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
HbA1c test 90 days after treatment Blood sample. Unit %
Clinical attachment level (CAL) 90 days after treatment This is the measurement of the position of the soft tissue attachment in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. Unit: millimeters
- Secondary Outcome Measures
Name Time Method Sulcus bleeding index (SBI) 90 days after treatment es/No at six sites around each tooth. Unit: % (sites with Sulcus bleeding/all sites)
Plaque index (PI) 90 days after treatment Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)