Diabetes Mellitus, Type 2, Periodontal Attachment Loss, Periodontal Diseases, Periodontal Inflammation, Periodontal Pocket, Periodontitis
Conditions
Keywords
Type 2 Diabetes Mellitus, Periodontal Disease, Antimicrobial Photodynamic Therapy, Indocyanine Green
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.
Interventions
PROCEDUREConventional Periodontal Treatment (Complete Oral Disinfection)
Oral hygiene instructions followed by complete oral disinfection (removal of hard and soft deposits, scaling and root planing, mouth rinse with 0.2% chlorhexidine twice in one minute, pocket rinse with 0.2% chlorhexidine three times in ten minutes). Ultrasonic (Piezoled, KaVo) and hand instruments (Gracey curettes, Hu-Friedy, USA) were used for this purpose. For the next 14 days, all patients were asked to rinse their oral cavities twice daily with 0.12% chlorhexidine.
PROCEDUREAdjunctive Photodynamic Therapy
Photodynamic Therapy as adjunctive treatment in pockets with PPD ≥ 5 mm. For this purpose, a Fotona XD -2 diode laser (Fotona, Ljubljana, Slovenia) with a wavelength of 810 nm, a power of 250 mW and the photosensitizing agent indocyanine green at a concentration of 1 mg/ml was used. First, the area to be irradiated was isolated, and the photosensitizing agent was applied to the periodontal pocket. After 60 seconds, the supragingival excess of the photosensitizing agent was removed by gentle rinsing with a saline solution. This was followed by irradiation for ten seconds on each side. For the next 14 days, all patients were asked to rinse their oral cavities twice daily with 0.12% chlorhexidine.
Sponsors
University Medical Centre Ljubljana
University of Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Test and Control group. All patients received oral hygiene instructions followed by complete oral disinfection (removal of hard and soft deposits, scaling and root planing, mouth rinse with 0.2% chlorhexidine twice in one minute, pocket rinse with 0.2% chlorhexidine three times in ten minutes). Ultrasonic (Piezoled, KaVo) and hand instruments (Gracey curettes, Hu-Friedy, USA) were used for this purpose. Afterwards, the patients were randomly divided into test and control groups. The patients in the test group received aPDT as adjuvant treatment in pockets with PPD ≥ 5 mm.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on probing (BOP) | At baseline | 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), | At baseline | 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 |
| HbA1c test | At baseline | Blood sample. Unit % |
| Probing pocket depth (PPD) | At baseline | Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters |
| Clinical attachment level (CAL) | At baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| Sulcus bleeding index (SBI) | At baseline | es/No at six sites around each tooth. Unit: % (sites with Sulcus bleeding/all sites) |
| Plaque index (PI) | At baseline | Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites) |
Outcome results
None listed