Minimally Invasive Non- Surgical Periodontal Therapy of Intrabony Defects: Molecular Healing Patterns and the Impact of Smoking on Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Concentrations of GCF inflammation and regeneration biomarkers.
研究概览
简要总结
This study is consisted of two arms. At first, a randomized controlled clinical trial will be conducted. Eighty systematically healthy, non-smoker patients with Periodontitis stage III or IV, grades B to C will be included. Each patient will have to present one intrabony defect site ( site with Probing Depth (PD)>5mm and radiographic defect depth > or =3mm). The patients will be randomized in two groups, regarding the treatment intervention of the intrabony defects: Group A (conventional Non-Surgical Periodontal Treatment, cNSPT) and Group B (Minimally Invasive Non-Surgical Therapy, MINST). At 5 days and 3 months following intervention, GCF samples will be collected from the intrabony defects in order to assess the molecular healing patterns through intergroup comparisons of inflammation and healing biomarkers. Then two prospective cohort studies will be conducted. The Group B patients will be matched with forty systematically healthy, smoker patients (Group C) with Periodontitis stage III or IV, grades B to C with each one presenting one intrabony defect site ( site with Probing Depth (PD)>5mm and radiographic defect depth > or =3mm). Then MINST will be performed in the patients of Group C and the two groups will be compared regarding the clinical and radiographic data obtained by clinical and radiographic examinations performed in both groups' intrabony defects pre-treatment and 6 months following the intervention (first prospective study) and regarding the differences in regeneration biomarkers in GCF samples obtained from the intrabony defects 5 days and 3 months post-treatment (second prospective study).
详细描述
The aim of this study is to define the possible differences of molecular healing response between MINST and cNSPT and, also, between smokers and non-smokers after MINST and to examine whether smoking is associated with inferior clinical outcomes after MINST.
The specific objectives of our study are:
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To compare the response of non-smokers after MINST and cNSPT in terms of inflammation and healing GCF biomarkers,
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To compare the response of non-smokers and smokers after MINST, in terms of clinical and radiographic outcomes,
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To compare the response of non-smokers and smokers after MINST, in terms of regeneration GCF biomarkers.
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Research implementation
-
Randomized controlled clinical trial (RCT) study
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with Periodontitis stage III or IV, grades B to C . Each patient will have to present one intrabony defect site ( site with Probing Depth (PD)>5mm and radiographic defect depth >3mm).
- •participants should be free of any systemic or oral conditions that could affect disease progression or treatment outcomes
排除标准
- •hepatic or renal disease
- •history of conditions requiring prophylactic antibiotics
- •anti-inflammatory or anticoagulant therapy the preceding month
- •systemic antibiotic therapy the preceding 3 months
- •history of alcohol or drug abuse
- •self-reported pregnancy or lactation
- •other severe acute or chronic medical or psychiatric condition
- •periodontal treatment within the last 12 months
- •presence of drug-induced gingival overgrowth
结局指标
主要结局
Concentrations of GCF inflammation and regeneration biomarkers.
时间窗: At 5 days and 3 months following intervention
Concentrations will be measured in pg/ml
Total amounts of GCF inflammation and regeneration biomarkers
时间窗: At 5 days and 3 months following intervention
Total amounts will be measured in pg/30 s
次要结局
- Gingival recession (REC)(pre-treatment and 6 months following the intervention)
- Angle of the intrabony defect(pre-treatment and 6 months following the intervention)
- Clinical attachment level (CAL)(pre-treatment and 6 months following the intervention)
- Distance between the CEJ and the alveolar bone crest(pre-treatment and 6 months following the intervention)
- Plaque index (PI)(pre-treatment and 6 months following the intervention)
- Probing depth (PD)(pre-treatment and 6 months following the intervention)
- Distance between the tooth cementoenamel junction (CEJ) and the bottom of the intrabony defect(pre-treatment and 6 months following the intervention)
- Depth of the intrabony defect(pre-treatment and 6 months following the intervention)
- Gingival index (GI)(pre-treatment and 6 months following the intervention)
- Bleeding on probing (BoP)(pre-treatment and 6 months following the intervention)
研究者
ILIAS OIKONOMOU
Principal Investigator, Periodontist, Department of Periodontology, 251 Hellenic Air Force & VA Hospital, Athens, Greece, Doctoral researcher, Department of Periodontology, Institute of Dentistry, University of Turku, Turku, Finland
University of Turku