Clinical trial NCT05816941: Antimicrobial Photodynamic Therapy in Patients With Periodontal Disease and Type 2 Diabetes Mellitus
Official title: The Effect of Antimicrobial Photodynamic Therapy on Periodontal Disease and Glycemic Control in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Diabetes Mellitus, Type 2
Periodontitis
Periodontal Pocket
Periodontal Attachment Loss
Periodontal Inflammation
Keywords: Type 2 Diabetes Mellitus
Periodontal Disease
Antimicrobial Photodynamic Therapy
Indocyanine Green
Lead sponsor: University of Ljubljana
Sponsor class: OTHER
Collaborators: name: University Medical Centre Ljubljana
First posted: 2023-04-18
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Probing pocket depth (PPD)
timeFrame: At baseline
measure: Probing pocket depth (PPD)
timeFrame: 90 days after treatment
measure: Bleeding on probing (BOP)
timeFrame: At baseline
measure: Bleeding on probing (BOP)
timeFrame: 90 days after treatment
measure: Clinical attachment level (CAL)
timeFrame: At baseline
measure: Clinical attachment level (CAL)
timeFrame: 90 days after treatment
measure: The presence of five periodontal pathogens, Aggregatibacter actinomycetemcomitans (AA), Porphyromonas gingivalis (PG), Prevotella intermedia (PI), Tanerella forsythia (TF) and Treponema denticola (TD),
timeFrame: At baseline
measure: The presence of five periodontal pathogens, Aggregatibacter actinomycetemcomitans (AA), Porphyromonas gingivalis (PG), Prevotella intermedia (PI), Tanerella forsythia (TF) and Treponema denticola (TD),
timeFrame: 90 days after treatment
measure: HbA1c test
timeFrame: At baseline
measure: HbA1c test
timeFrame: 90 days after treatment
Secondary outcomes:
measure: Plaque index (PI)
timeFrame: At baseline
measure: Plaque index (PI)
timeFrame: 90 days after treatment
measure: Sulcus bleeding index (SBI)
timeFrame: At baseline
measure: Sulcus bleeding index (SBI)
timeFrame: 90 days after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Assistant Professor
name: Rok Schara
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.