Survival of Molars With Degree III Periodontal Furcation Involvement Following Non-surgical or Surgical Therapy: a Multicentre Single-masked Superiority Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- 5-year tooth survival
研究概览
简要总结
Periodontitis is an inflammatory disease of the tooth-supporting apparatus, which leads to attachment and bone loss and eventually to tooth loss if treatment is not provided.
When the periodontitis-related bone loss affects the area of root separation in molars, a furcation involvement (FI) is created. This represents a challenge in the treatment of periodontally-compromised molars, affecting the majority of patients with periodontitis. Based on a prevalence of severe forms of periodontitis in the UK and worldwide of about 10% of the population and on previous studies, we can assume that at least 5-10% of the general population are affected by FI.
Different treatment modalities are advocated for the treatment of FI, including non-surgical maintenance, resective (bone recontouring) and regenerative (reconstruction of bone and attachment) surgical treatments or tooth extraction. It has clearly emerged that FI at least doubles the risk of tooth loss. However, in the case of advanced through-and-through loss of attachment and bone in the furcation area (FI degree III), the clinician is often faced with a very difficult treatment decision, without being able to draw on much evidence from the literature. Interestingly, there are no randomised controlled trials exploring the most appropriate treatment for advanced furcation involvement. This has been highlighted in a recent systematic review commissioned by the European Federation of Periodontology.
详细描述
Subject recruitment All patients will be recruited from Periodontal Clinics at the participating centres in United Kingdom (Ravenscourt Dental Practice, 5 Ravenscourt avenue, Germany (University Hospital of Berlin, Bonn, Frankfurt and Greifswald), Sweden (Malmo), Spain (Santiago de Compostela), Italy (Torino) and Australia (Brisbane). When a potentially suitable patient is identified in the clinics, the assigned hospital consultant (or equivalent outside the UK) will inform him/her of the study and ask if the patient is interested in discussing this with a member of the research team. Then a member of the research team will approach the patient, provide more information about the study procedures and will give them an information sheet about the study. If the patient agrees to take part, they will be offered a baseline appointment. If they need more time to consider participation, they will be contacted by phone by a member of the periodontology research team within 1 week to enquire about their willingness to take part in the study and to give them the opportunity to ask any questions about the study. If all inclusion/exclusion criteria cannot be verified at the new patient clinic appointment, a review appointment prior to baseline will be offered. Each subject will be part of the study for approximately 5 years.
At the time of subject recruitment in addition to information about the study; the overall management plan will be discussed with the patient. The responsible consultant (or equivalent) will provide information about the treatment of the non-study sites and what additional treatment will be provided for those areas. This will commence once the study sites have been treated. If any other dental treatment is required before the baseline visit (e.g. fillings or extractions), as judged by the responsible consultant (or equivalent), such treatment will be carried out prior to baseline.
Screening Procedures Potential new patients which may be suitable for the study will be screened alongside all other patients attending Periodontology clinics at the participating centres and accepted based upon the inclusion and exclusion criteria above.
Randomisation Procedures Randomisation for test or control treatment will be carried out between baseline (visit 1) and visit 2. The randomisation service 'Sealed envelope' will be used in each centre for randomisation and to ensure allocation concealment. A sealed envelope will be enclosed with the patient's notes by personnel not directly involved in the study. The therapist will be informed about treatment allocation by opening the envelope at the beginning of the treatment appointment.
For each centre patients will be allocated to the two treatment groups using a randomisation list that was previously prepared by the study statistician. For important influencing factors ('centre') stratified randomisation will be carried out as recommended , especially in case of small sample sizes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum of 12 teeth present
- •Diagnosis of Severe Periodontitis stage III or IV
- •At least one maxillary/ mandibular molar with: i) degree III horizontal furcation involvement (at least between 2 roots for maxillary molars) , ii) class B vertical furcation involvement (bone loss up to the middle third of root cones), iii) residual probing pocket depths > 5 mm in furcation area, iv) maximum mobility degree Iand v) not already accessible for self-performed oral hygiene
- •Received a course of non-surgical periodontal therapy within the past six months
排除标准
- •Full mouth plaque score > 30%
- •A course of antibiotics within the past 3 months
- •Pregnant/lactating women
- •Relevant medical history as evaluated by the examining clinician which may have the potential to affect periodontal surgical treatment
- •Individuals on long-standing (2 or above years) supportive periodontal therapy (SPT) management plans
- •Molar affected by FI:
- •Ongoing endodontic pathology affecting the furcation involved molar, as judged by the examining clinician
- •Previous periodontal surgical treatment to the furcation affected molar within the previous 5 years
- •Endodontically treated molar tooth without a full coverage restoration
- •'Unrestorable' molar tooth (lacking adequate tooth structure to provide a restoration) as deemed by the examining clinician.
- •Molar tooth acting as a bridge abutment
- •The presence of occlusal dysfunction as assessed by the examining clinician
结局指标
主要结局
5-year tooth survival
时间窗: 5 years
to test the survival of the tooth with advanced furcation after 5 years
次要结局
- Maximum Clinical attachment level CAL(5 years)
- Radiographic bone levels(5 years)
- Patient's discomfort measurement(5 years)
- Fractures(5 years)
- Endodontic complications(5 years)
- Maximum Pocket depth (PPD)(5 years)
- Time needed for each study appointment during maintenance therapy(5 years)
- Occurrence of root caries in furcation area(5 years)
- 1-year tooth survival(1 year)
- 3-year tooth survival(3 years)
- Cost-effectiveness Analysis(5 years)
- Cost-Utility analyses(5 years)
- Microbiological analysis(5 years)
- Further treatment needed(5 years)
- Tooth mobility(5 years)