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

May 17, 2023 updated by: University of Ljubljana

The Effect of Antimicrobial Photodynamic Therapy on Periodontal Disease and Glycemic Control in Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline
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
90 days after treatment
HbA1c test
Time Frame: At baseline
Blood sample. Unit %
At baseline
HbA1c test
Time Frame: 90 days after treatment
Blood sample. Unit %
90 days after treatment
Probing pocket depth (PPD)
Time Frame: At baseline
Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
At baseline
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
90 days after treatment
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)
At baseline
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)
90 days after treatment
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
At baseline
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
90 days after treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ljubljana

Collaborators

University Medical Centre Ljubljana

Investigators

  • Study Director: Rok Schara, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2016

Primary Completion (Actual)

January 3, 2019

Study Completion (Actual)

January 3, 2019

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • aPTD in Pariodontal Treatment

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All Research data will be available or shared on individual request. Example: conducting Meta-Analysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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