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| Name | Class |
|---|---|
| University Medical Centre Ljubljana | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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), |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque index (PI) | Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites) | At baseline |
| Plaque index (PI) | Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rok Schara | Assistant Professor | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26921460 | Background | 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. | |
| 18713259 |
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All Research data will be available or shared on individual request. Example: conducting Meta-Analysis.
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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.
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| Adjunctive Photodynamic Therapy | Procedure | 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. |
|
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 |
| 90 days after treatment |
| Sulcus bleeding index (SBI) | es/No at six sites around each tooth. Unit: % (sites with Sulcus bleeding/all sites) | At baseline |
| Sulcus bleeding index (SBI) | es/No at six sites around each tooth. Unit: % (sites with Sulcus bleeding/all sites) | 90 days after treatment |
| Background |
| 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. |
| 19563331 | Background | 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. |
| 19554711 | Background | 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. |
| 21166588 | Background | 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. |
| 27448223 | Background | 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. |
| 37672083 | Derived | 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. |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D003924 | Diabetes Mellitus, Type 2 |
| D010518 | Periodontitis |
| D010514 | Periodontal Pocket |
| D017622 | Periodontal Attachment Loss |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D055093 | Periodontal Atrophy |
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