Assessment of Tooth Mobility After Non-surgical Periodontal Treatment Followed by Tooth Splinting
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluation of dental mobility with a customized device before and after non-surgical periodontal therapy and after stabilization by periodontal splints
研究概览
简要总结
This clinical study aims to investigate changes in tooth mobility after non-surgical periodontal treatment in anterior teeth with mobility. Twenty patients from the Piracicaba Dental School - Unicamp, diagnosed with stage III or IV periodontitis and grade 2 or 3 tooth mobility, will be selected. Mobility will be assessed using an innovative method involving a customized plate and a tensiometer adapted to apply controlled force.
Initially, participants will undergo a detailed clinical examination, including periodontal evaluation, occlusal analysis, and gingival crevicular fluid collection. After periodontal treatment, which will involve scaling and root planing, mobility will be reassessed after 60 days. Then, a temporary fiber-reinforced resin splint will be applied to the affected teeth and maintained for another 60 days. At the end of the period, the splint will be removed, and new assessments will be conducted.
The study will also analyze the impact of treatment on patients' quality of life (OHIP-14) and the levels of bone and inflammatory markers (OPG, RANK/RANKL, IL-1β, and TNF-α). The findings are expected to provide a better understanding of the response of mobile teeth to periodontal treatment and the role of splinting in stabilizing periodontal tissues.
详细描述
Study Location and Participants
The study will be conducted at the Specialization Clinic of the Piracicaba Dental School (FOP-Unicamp). Participants will be voluntary patients receiving clinical care at the Undergraduate Clinic of FOP, diagnosed with stage III or IV periodontitis with grades A, B, or C (Papapanou et al., 2018). The inclusion criteria are: periodontal pockets ≥ 4 mm, anterior teeth with mobility (grade 2 or 3) and periodontal attachment loss, and participants of both sexes aged 18 years or older.
All participants will receive treatment in the sextant of the affected tooth/teeth by the researcher, while periodontal treatment of the remaining sextants will be performed as part of the activities of the Undergraduate Clinic at FOP.
Procedure Phase 1: Assessment of Mobility, Clinical Parameters, and Bone Markers Before Non-Surgical Periodontal Treatment Clinical Parameters Initially, volunteers will receive information regarding the etiology and pathogenesis of periodontal diseases. A detailed periodontal evaluation will be performed on the affected sextant (2/5), assessing probing depth (PD) and clinical attachment level (CAL) at six sites per tooth using a calibrated periodontal probe (PCP-UNC 15 tip, Hu-Friedy, Chicago, IL). A complementary periapical radiographic examination will be performed (regions 13-23/33-43), along with the administration of the OHIP-14 questionnaire.
Fabrication of the Tooth Mobility Assessment Device Customized Tray Plate A customized tray plate will be fabricated using Polyethylene Terephthalate Glycol (PET-G) (Bio-Art; Bio-Art Soluções Inteligentes), based on a plaster model of the patient's dentition with a thickness of 1.0 mm. A 3 mm resin layer will be applied over the mobile tooth in the plaster model, creating space on the buccal, lingual/palatal, and incisal surfaces. Relief areas will be made in the acetate plate on the surfaces of mobile teeth, in a circular shape, with diameters larger than 10 mm to allow for displacement force application and measurement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Stage III and IV Periodontitis (grades A, B and C).
- •With periodontal pockets ≥ 4 mm.
- •Anterior teeth (13-23 and 33-43) with dental mobility (grade 2 or 3).
- •≥ 18 years old.
排除标准
- •Crossbite or edge-to-edge
- •Absence of posterior occlusal contact
- •Implants adjacent to the tooth with mobility
- •Extreme mobility
- •Patients requiring prophylactic antibiotics
- •Diabetics
研究组 & 干预措施
Tooth Mobility Assessment
Evaluation of dental mobility before and after non-surgical periodontal treatment, after stabilization by periodontal splints.
干预措施: Periodontal Treatment (Procedure)
Tooth Mobility Assessment
Evaluation of dental mobility before and after non-surgical periodontal treatment, after stabilization by periodontal splints.
干预措施: assessment of tooth mobility before and after periodontal treatment (Other)
Tooth Mobility Assessment
Evaluation of dental mobility before and after non-surgical periodontal treatment, after stabilization by periodontal splints.
干预措施: Evaluation of Clinical Parameters (Other)
结局指标
主要结局
Evaluation of dental mobility with a customized device before and after non-surgical periodontal therapy and after stabilization by periodontal splints
时间窗: Baseline (Day 0), post- treatment non-surgical periodontal(Day 60), and post splinting (Day 120)
Tooth mobility will be measured using a custom-made device specifically designed for each patient, allowing for standardized and reproducible assessment. Evaluations will occur at three time points: before the initiation of non-surgical periodontal therapy (baseline), at 60 days (after non-surgical treatment), and at 120 days (after splinting). This method ensures consistent positioning and pressure application during assessments. Each participant will serve as their own control, and the individual tooth will be considered the statistical unit.
次要结局
未报告次要终点
研究者
Enilson Antonio Sallum
Full Professor
University of Campinas, Brazil