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

Sponsor

University of Ljubljana (Other)

Overall Status

Completed

CT.gov ID

NCT05816941

Collaborator

University Medical Centre Ljubljana (Other)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontal Diseases Diabetes Mellitus, Type 2 Periodontitis Periodontal Pocket Periodontal Attachment Loss Periodontal Inflammation	Procedure: Conventional Periodontal Treatment (Complete Oral Disinfection) Procedure: Adjunctive Photodynamic Therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Antimicrobial Photodynamic Therapy on Periodontal Disease and Glycemic Control in Patients With Type 2 Diabetes Mellitus

Actual Study Start Date :

Jan 3, 2016

Actual Primary Completion Date :

Jan 3, 2019

Actual Study Completion Date :

Jan 3, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Control Arm Conventional Periodontal Treatment: Complete Oral Disinfection.	Procedure: Conventional 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.
Experimental: Experimental Arm Conventional Periodontal Treatment (Complete Oral Disinfection) and Adjunctive Photodynamic Therapy in periodontal pockets with PPD ≥ 5 mm.	Procedure: Conventional 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. Procedure: Adjunctive 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.

Arm

Intervention/Treatment

Other: Control Arm

Conventional Periodontal Treatment: Complete Oral Disinfection.

Procedure: Conventional 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.

Experimental: Experimental Arm

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

Procedure: Conventional Periodontal Treatment (Complete Oral Disinfection)

Procedure: Adjunctive 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.

Outcome Measures

Primary Outcome Measures

Probing pocket depth (PPD) [At baseline]
Probing pocket depth measured using manual probe at 6 sites around each tooth. Unite: millimeters
Probing pocket depth (PPD) [90 days after treatment]
Probing pocket depth measured using manual probe at 6 sites around each tooth. Unite: millimeters
Bleeding on probing (BOP) [At baseline]
Yes/No after probing pocket depth measurement 6 sites around each tooth. Unite: % (bleeding sites/all sites)
Bleeding on probing (BOP) [90 days after treatment]
Yes/No after probing pocket depth measurement 6 sites around each tooth. Unite: % (bleeding sites/all sites)
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. Unite: millimeters
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. Unite: millimeters
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
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
HbA1c test [At baseline]
Blood sample. Unit %
HbA1c test [90 days after treatment]
Blood sample. Unit %

Secondary Outcome Measures

Plaque index (PI) [At baseline]
Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)
Plaque index (PI) [90 days after treatment]
Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)
Sulcus bleeding index (SBI) [At baseline]
es/No at six sites around each tooth. Unit: % (sites with Sulcus bleeding/all sites)
Sulcus bleeding index (SBI) [90 days after treatment]
es/No at six sites around each tooth. Unit: % (sites with Sulcus bleeding/all sites)

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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