The Impact of Correct and Efficient Oral Hygiene Maneuvers on Markers of Systemic Inflammation and Overall Well-being.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change from baseline of High sensitivity C-Reactive Protein (hsCRP) at 1 month
研究概览
简要总结
The purpose of the study is to evaluate the impact of oral hygiene changes (drastic plaque and gingival inflammation reduction) on markers of systemic inflammation and indicators of oral health related quality of life and other aspects related to overall well-being.
The primary objective is to assess a possible reduction of systemic inflammation as measured through blood bio-markers one month after drastic changes of plaque accumulation. As primary outcome measure, the level of high-sensitive C-reactive protein (hs-CRP) will be assessed.
详细描述
This study is a single-center, 2 arms, randomized parallel group double-blind clinical trial with one month follow-up, involving patients with no conditions capable of alteration of the systemic inflammatory levels as measured by C-reactive protein (CRP).
Screening will be actuated through a two-step procedure: a careful dental and medical examination will be collected. Subjects with negative history for the conditions tested will undergo blood testing to further confirm the anamnestic findings. Center investigators will document in a screening log reasons for ineligibility or exclusion of subjects. Thus, subjects fulfilling the inclusion criteria will be invited to participate. Clinical center will enroll probands, assigning a unique study subject number and allocating an opaque randomization envelope.
Informed consent will be obtained by the center investigator who will describe the objectives of the study, the alternatives and risks associated with study participation as well as the possibility to withdraw at any time without compromise for the treatment. Consent procedures and documentation of consent will be performed at the screening visit in the national language of the patient and in accordance with local best practice and regulations.
Patients included in the study will undergo a thorough clinical examination aiming at collecting all the data desired (oral and systemic parameters, blood sampling and questionnaires fulfilment). After examinations, the opaque envelope with associated the code of the patient will be opened identifying whether the patient enters Test or Control group.
Patients will also receive a session of professional supragingival scaling and polishing: instrumentation will be performed by a trained dental hygienist/periodontist with great care in performing exclusively coronal maneuver. No instrumentation or exploring of the gingival crevice/ sulcus will be 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
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcome assessor will not be present during explanation of oral hygiene maneuvers. Moreover, participants will be asked not to mention about techniques and group participation to the outcome assessors.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female, 18 to 79 of age, of any race/ethnicity;
- •presence of at least 20 teeth;
- •≤ 2 untreated dental caries;
- •presence of relevant plaque accumulation as shown by Full Mouth Plaque Scores (FMBS) >50%.
- •presence of relevant periodontal/gingival inflammation as shown by FMBS > 35%
排除标准
- •• pregnancy and breast feeding;
- •patients undergoing pharmacological treatment capable of reducing CRP such as statins or chronic anti-inflammatory treatment,
- •current or past (≤ 30 days) systemic or local antibiotic therapy;
- •heavy smokers (over 20 cigarettes per day or pipe or cigar);
- •patients undergoing orthodontic treatment;
- •patients not capable to comply with given instruction or administrative issues related to the study
- •dental or periodontal conditions (e.g., deep caries, periodontal abscess) requiring urgent treatment
结局指标
主要结局
Change from baseline of High sensitivity C-Reactive Protein (hsCRP) at 1 month
时间窗: Difference of values of the markers collected at Baseline and 1 month after treatment
analyzed though blood sampling. Unit of measure: mg/L
次要结局
- Vitamin D(Collected at Baseline)
- Pocket probing depth (PPD)(Measured at Baseline and 1 month after treatment)
- Clinical attachment level (CAL)(Measured at Baseline and 1 month after treatment)
- Change from baseline of Interleukin 6 at 1 month(Difference of values of the markers collected at Baseline and 1 month after treatment)
- Full-mouth plaque score (FMPS)(Measured at Baseline and 1 month after treatment)
- Full-mouth bleeding score (FMBS)(Measured at Baseline and 1 month after treatment)
- Recession of the gingival margin (REC)(Measured at Baseline and 1 month after treatment)
- Changes of sum of Oral Health Index Profile-14(Measured at Baseline and 1 month after trea)
- Changes of sum of Pittsburgh sleep quality index (PSQI)(Measured at Baseline and 1 month after trea)
- Changes of sum of Oxford Happiness Questionnaire (OHQ)(Measured at Baseline and 1 month after treatment)
- Food Frequency Questionnaire (FFQ)(Measured at Baseline and 1 month after treatment)
- Changes of sum of Memory Assessment Clinics - Questionnaire (MAC-Q)(Measured at Baseline and 1 month after treatment)
研究者
Filippo Graziani, DDS MClinDent PhD
Full Professor of Dentistry
University of Pisa