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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05816941
• Other study ID #: aPTD in Pariodontal Treatment
• Status: Completed
• Phase: N/A
• Start date: January 3, 2016
• Est. completion date: January 3, 2019

Study information

• Verified date: May 2023
• Source: University of Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 3, 2019
• Est. primary completion date: January 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Inflammation
• Periodontal Attachment Loss
• Periodontal Diseases
• Periodontal Inflammation
• Periodontal Pocket
• Periodontitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Ljubljana	University Medical Centre Ljubljana

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing pocket depth (PPD)	Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters	At baseline
Primary	Probing pocket depth (PPD)	Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters	90 days after treatment
Primary	Bleeding on probing (BOP)	Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)	At baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	HbA1c test	Blood sample. Unit %	At baseline
Primary	HbA1c test	Blood sample. Unit %	90 days after treatment
Secondary	Plaque index (PI)	Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)	At baseline
Secondary	Plaque index (PI)	Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)	90 days after treatment
Secondary	Sulcus bleeding index (SBI)	es/No at six sites around each tooth. Unit: % (sites with Sulcus bleeding/all sites)	At baseline
Secondary	Sulcus bleeding index (SBI)	es/No at six sites around each tooth. Unit: % (sites with Sulcus bleeding/all sites)	90 days after treatment