Clinical and Radiographic Evaluation of Intentional Replantation Treatment in Periodontally Hopeless Teeth, Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical attachment loss (CAL)
研究概览
简要总结
Replantation is defined as the intentional extraction and repositioning of teeth that have lost their periodontal support. The aim of this study is to evaluate the clinical and radiographic follow-up results of planned replantation treatment in cases with advanced periodontal destruction and to compare it with splinting alone.
Twenty-five patients with periodontal damage in the control group and 25 patients in the experimental group will be included in the study. The clinical parameters of both groups will be evaluated at baseline, 1, 3, and 6 months using periodontal indices and the Visual Analog Scale (VAS).
详细描述
Fifty individuals aged 18-65 with severe clinical attachment loss (>3 mm) and alveolar bone loss (⅔ or more of the root) in their lower anterior incisors will participate in the study, taking into account the inclusion and exclusion criteria. All patients will undergo non-surgical periodontal treatment before being divided into groups. Patients who meet the inclusion criteria will be randomly selected for the experimental and control groups:
Control group (n=25): The group that will undergo conventional root canal treatment and be followed up with a splint Experimental group (n=25): The group that will undergo conventional root canal treatment followed by planned replantation treatment and splinting.
Infiltrative anesthesia is applied to the tooth planned for replantation. The tooth is extracted with care not to cause trauma to the surrounding tissues. Care is taken not to touch the root surface of the extracted tooth, especially in areas where it comes into contact with the bone apically, in order not to damage the cells that promote healing. If there are attachments on the root surface, they are removed with ultrasound. The tooth is placed in the prepared tetracycline solution and left for 5 minutes. During this time, the extraction socket is gently checked to ensure it is clean. Any granulation tissue that would prevent the tooth root from settling into the bone and making contact is removed. The tooth is removed from the tetracycline solution and placed in the socket. The tooth is stabilized and a temporary splint is applied. Contacts are removed during closure and intrusive movements. The patient is informed that they should not bite or tear with their front teeth and that they should protect the tooth. After 2 weeks, a permanent periodontal splint will be applied.
The clinical parameters of the patients participating in the study will be monitored for 6 months, and the success of the planned replantation treatment will be evaluated by comparing the data from the control group and the test group. It will be investigated whether there is a significant difference between the treatments applied to the control and test groups in terms of clinical and radiographic findings and patient satisfaction.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients are systemically healthy or have their systemic conditions under control.
- •Lower anterior incisors (42, 41, 31, 32) will be included.
- •Mobility classification will be Miller
- •Radiograph showing 50% or more bone loss at the root.
- •Probing depth of 5 mm or more.
- •Bone level of adjacent teeth at ⅔ or better than the root.
- •Mobility of adjacent teeth will be Miller 0 or Miller
- •The patient prefers to keep the tooth in the mouth rather than having it extracted.
排除标准
- •Systemic Comorbidity
- •Root Resorption
- •Root Fracture or Crack
- •Ankylosis of the Tooth
研究组 & 干预措施
Replantation
Replantation group (n=25): Group that underwent conventional canal treatment followed by planned replantation treatment and splinting.
干预措施: Replantation (Procedure)
Splint
Splint group (n=25): The group that will undergo conventional canal treatment and splinting.
干预措施: Splint (Procedure)
结局指标
主要结局
Clinical attachment loss (CAL)
时间窗: Baseline, 3rd and 6th months
CAL is measured as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus (the most coronal attachment) using a Williams periodontal probe. The changes in clinical attachment loss was measured for determining the severity of disease.
Bone Loss,(BL)
时间窗: Baseline and 6th monts
The pre- and post-treatment tooth length/bone ratio around the tooth root will be determined using CBCT and periapical radiographs. The amount of bone loss (% bone loss, BL) will be determined using a millimeter scale from both the mesial and distal regions of the teeth, according to the method described by Schulte and colleagues (10) using periapical radiographs. To determine individual bone loss, intra-alveolar root length (hi) and total root length (hg) are measured. Hg, the total root length, is defined as the distance from the apex to the proximal enamel-cementum junction, parallel to the long axis of the teeth. Since the distance between the alveolar bone crest and the enamel-cementum junction varies between 0.75 and 1.49 mm, 1.5 mm is subtracted from the total root length during calculation. The intra-alveolar root length is defined as the distance from the apex to the highest point on the alveolar margin. The change in bone loss at baseline and at 6 months will be examined.
次要结局
- Gingival index (GI)(Baseline, 3rd and 6th months)
- Bleeding on probing (BOP)(Baseline, 3rd and 6th months)
- Probing pocket depth (PPD)(Baseline, 3rd and 6th months)
- Mobility(Baseline, 3rd and 6th months)
- Plaque index (PI)(Baseline, 3rd and 6th months)
- VAS measurement values(Baseline, 3rd and 6th months)
研究者
Tuğçe Paksoy
associate professor
Saglik Bilimleri Universitesi