NCT05816941

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2019

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

3 years

First QC Date

March 17, 2023

Last Update Submit

May 17, 2023

Conditions

Periodontal DiseasesDiabetes Mellitus, Type 2PeriodontitisPeriodontal PocketPeriodontal Attachment LossPeriodontal Inflammation

Keywords

Type 2 Diabetes MellitusPeriodontal DiseaseAntimicrobial Photodynamic TherapyIndocyanine Green

Outcome Measures

Primary Outcomes (10)

  • Probing pocket depth (PPD)

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

    At baseline

  • Probing pocket depth (PPD)

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

    90 days after treatment

  • Bleeding on probing (BOP)

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

    At baseline

  • Bleeding on probing (BOP)

    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)

    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)

    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

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

    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),

    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

    Blood sample. Unit %

    At baseline

  • HbA1c test

    Blood sample. Unit %

    90 days after treatment

Secondary Outcomes (4)

  • Plaque index (PI)

    At baseline

  • Plaque index (PI)

    90 days after treatment

  • Sulcus bleeding index (SBI)

    At baseline

  • Sulcus bleeding index (SBI)

    90 days after treatment

Study Arms (2)

Control Arm

OTHER

Conventional Periodontal Treatment: Complete Oral Disinfection.

Procedure: Conventional Periodontal Treatment (Complete Oral Disinfection)

Experimental Arm

EXPERIMENTAL

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

Interventions

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.

Control ArmExperimental Arm
Adjunctive Photodynamic TherapyPROCEDURE

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.

Experimental Arm

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Monzavi A, Chinipardaz Z, Mousavi M, Fekrazad R, Moslemi N, Azaripour A, Bagherpasand O, Chiniforush N. Antimicrobial photodynamic therapy using diode laser activated indocyanine green as an adjunct in the treatment of chronic periodontitis: A randomized clinical trial. Photodiagnosis Photodyn Ther. 2016 Jun;14:93-7. doi: 10.1016/j.pdpdt.2016.02.007. Epub 2016 Feb 24.

    PMID: 26921460BACKGROUND

  • Braun A, Dehn C, Krause F, Jepsen S. Short-term clinical effects of adjunctive antimicrobial photodynamic therapy in periodontal treatment: a randomized clinical trial. J Clin Periodontol. 2008 Oct;35(10):877-84. doi: 10.1111/j.1600-051X.2008.01303.x. Epub 2008 Aug 17.

    PMID: 18713259BACKGROUND

  • Lulic M, Leiggener Gorog I, Salvi GE, Ramseier CA, Mattheos N, Lang NP. One-year outcomes of repeated adjunctive photodynamic therapy during periodontal maintenance: a proof-of-principle randomized-controlled clinical trial. J Clin Periodontol. 2009 Aug;36(8):661-6. doi: 10.1111/j.1600-051X.2009.01432.x. Epub 2009 Jun 25.

    PMID: 19563331BACKGROUND

  • Polansky R, Haas M, Heschl A, Wimmer G. Clinical effectiveness of photodynamic therapy in the treatment of periodontitis. J Clin Periodontol. 2009 Jul;36(7):575-80. doi: 10.1111/j.1600-051x.2009.01412.x.

    PMID: 19554711BACKGROUND

  • Ge L, Shu R, Li Y, Li C, Luo L, Song Z, Xie Y, Liu D. Adjunctive effect of photodynamic therapy to scaling and root planing in the treatment of chronic periodontitis. Photomed Laser Surg. 2011 Jan;29(1):33-7. doi: 10.1089/pho.2009.2727. Epub 2010 Dec 18.

    PMID: 21166588BACKGROUND

  • Castro Dos Santos NC, Andere NM, Araujo CF, de Marco AC, Dos Santos LM, Jardini MA, Santamaria MP. Local adjunct effect of antimicrobial photodynamic therapy for the treatment of chronic periodontitis in type 2 diabetics: split-mouth double-blind randomized controlled clinical trial. Lasers Med Sci. 2016 Nov;31(8):1633-1640. doi: 10.1007/s10103-016-2030-8. Epub 2016 Jul 22.

    PMID: 27448223BACKGROUND

  • Brinar S, Skvarca A, Gaspirc B, Schara R. The effect of antimicrobial photodynamic therapy on periodontal disease and glycemic control in patients with type 2 diabetes mellitus. Clin Oral Investig. 2023 Oct;27(10):6235-6244. doi: 10.1007/s00784-023-05239-0. Epub 2023 Sep 6.

    PMID: 37672083DERIVED

MeSH Terms

Conditions

Periodontal DiseasesDiabetes Mellitus, Type 2PeriodontitisPeriodontal PocketPeriodontal Attachment Loss

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPeriodontal Atrophy

Study Officials

  • Rok Schara

    Assistant Professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2023

First Posted

April 18, 2023

Study Start

January 3, 2016

Primary Completion

January 3, 2019

Study Completion

January 3, 2019

Last Updated

May 18, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

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