The Effect of Antimicrobial Photodynamic Therapy on Periodontal Disease and Glycemic Control in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- HbA1c test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Former smokers who had stopped smoking less than five years before participation
研究组 & 干预措施
Control Arm
Conventional Periodontal Treatment: Complete Oral Disinfection.
干预措施: Conventional Periodontal Treatment (Complete Oral Disinfection) (Procedure)
Experimental Arm
Conventional Periodontal Treatment (Complete Oral Disinfection) and Adjunctive Photodynamic Therapy in periodontal pockets with PPD ≥ 5 mm.
干预措施: Conventional Periodontal Treatment (Complete Oral Disinfection) (Procedure)
Experimental Arm
Conventional Periodontal Treatment (Complete Oral Disinfection) and Adjunctive Photodynamic Therapy in periodontal pockets with PPD ≥ 5 mm.
干预措施: Adjunctive Photodynamic Therapy (Procedure)
结局指标
主要结局
HbA1c test
时间窗: 90 days after treatment
Blood sample. Unit %
Bleeding on probing (BOP)
时间窗: 90 days after treatment
Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)
The presence of five periodontal pathogens, Aggregatibacter actinomycetemcomitans (AA), Porphyromonas gingivalis (PG), Prevotella intermedia (PI), Tanerella forsythia (TF) and Treponema denticola (TD),
时间窗: 90 days after treatment
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
Probing pocket depth (PPD)
时间窗: 90 days after treatment
Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
Clinical attachment level (CAL)
时间窗: 90 days after treatment
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
Probing pocket depth (PPD)
时间窗: At baseline
Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
Bleeding on probing (BOP)
时间窗: At baseline
Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)
Clinical attachment level (CAL)
时间窗: At baseline
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
The presence of five periodontal pathogens, Aggregatibacter actinomycetemcomitans (AA), Porphyromonas gingivalis (PG), Prevotella intermedia (PI), Tanerella forsythia (TF) and Treponema denticola (TD),
时间窗: At baseline
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
HbA1c test
时间窗: At baseline
Blood sample. Unit %
次要结局
- Sulcus bleeding index (SBI)(90 days after treatment)
- Plaque index (PI)(90 days after treatment)
- Plaque index (PI)(At baseline)
- Sulcus bleeding index (SBI)(At baseline)