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NCT Number: NCT05816941

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

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.

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Key information

Conditions

Periodontal Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Atrophy Periodontal Attachment Loss Periodontal Inflammation Periodontal Pocket Periodontitis Stomatognathic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Periodontal Treatment (Complete Oral Disinfection)

Procedure

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.

Adjunctive Photodynamic Therapy

Procedure

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.

Primary outcomes

  1. Probing pocket depth (PPD)

    Time frame: At baseline

    Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters

  2. Probing pocket depth (PPD)

    Time frame: 90 days after treatment

    Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters

  3. Bleeding on probing (BOP)

    Time frame: At baseline

    Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)

  4. Bleeding on probing (BOP)

    Time frame: 90 days after treatment

    Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)

  5. Clinical attachment level (CAL)

    Time frame: 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

  6. Clinical attachment level (CAL)

    Time frame: 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

  7. The presence of five periodontal pathogens, Aggregatibacter actinomycetemcomitans (AA), Porphyromonas gingivalis (PG), Prevotella intermedia (PI), Tanerella forsythia (TF) and Treponema denticola (TD),

    Time frame: 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

  8. The presence of five periodontal pathogens, Aggregatibacter actinomycetemcomitans (AA), Porphyromonas gingivalis (PG), Prevotella intermedia (PI), Tanerella forsythia (TF) and Treponema denticola (TD),

    Time frame: 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

  9. HbA1c test

    Time frame: At baseline

    Blood sample. Unit %

  10. HbA1c test

    Time frame: 90 days after treatment

    Blood sample. Unit %

Secondary outcomes

  1. Plaque index (PI)

    Time frame: At baseline

    Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)

  2. Plaque index (PI)

    Time frame: 90 days after treatment

    Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)

  3. Sulcus bleeding index (SBI)

    Time frame: At baseline

    es/No at six sites around each tooth. Unit: % (sites with Sulcus bleeding/all sites)

  4. Sulcus bleeding index (SBI)

    Time frame: 90 days after treatment

    es/No at six sites around each tooth. Unit: % (sites with Sulcus bleeding/all sites)

Sponsors and collaborators

Lead sponsor

University of Ljubljana

Other

Collaborators

  • University Medical Centre Ljubljana

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2023
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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