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
Verified date | May 2023 |
Source | University of Ljubljana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Ljubljana | University Medical Centre Ljubljana |
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
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 |
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