Clinical- and Patient-reported Outcomes Following Treatment of Grade III Furcation-involved Molars. A Single-centre Single-masked Randomised Controlled Feasibility Trial With SMART Design.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of patients
研究概览
简要总结
Periodontitis, a microbially-driven inflammatory disease has been shown to be the sixth most common disease of mankind. The 2009 UK Adult Dental Health Survey found that 54% of adults experience gum bleeding (gingivitis) with 45% of these suffering from periodontitis. Periodontitis begins at the gingival margins of teeth and over time, in susceptible individuals, the presence of a plaque biofilm can lead to the loss of the supporting connective tissue and alveolar bone associated with the teeth. This leads to the formation of a pathological periodontal pocket between the gingiva and tooth root, measurable by the use of a periodontal probe and recorded as the probing pocket depth (PPD). The associated loss of alveolar bone support is measurable radiographically and often leads to tooth mobility and if allowed to persist, can eventually lead to tooth loss. Periodontitis is classified into 4 stages (I-IV) based on disease severity and 3 grades (A-B-C) based on risk of disease progression.
The treatment of periodontitis involves a non-specific reduction of the bacterial load below the gingival margin. This is achieved by effective oral hygiene procedures and non-surgical periodontal therapy (NSPT), both of which are aimed at the removal of calculus (tartar) deposits and the disruption of the plaque biofilm from the affected root surfaces. In some cases, this treatment may then be followed by more invasive treatments such as periodontal surgery and if successful, patients can then be followed and maintained with supportive periodontal maintenance therapy (SPT). It should be noted that certain periodontal lesions in some patients do not however always respond favourably to treatment.
详细描述
Study teeth will have received at least one course of non-surgical periodontal treatment (NSPT) prior inclusion to the trial. At the baseline appointment participants will be randomly assigned to a treatment arm to receive either non-surgical periodontal treatment (n=10) or surgical periodontal treatment (n=10) for the first treatment phase. This is consistent with standard periodontal treatment procedures as it has been shown that either treatment can be considered as a valid option for cases of periodontitis where residual periodontal pocketing remains.
Simple randomisation will be completed using the online programme, Sealed Envelope. This will be completed by a member of the research team not involved in this specific study. Sealed Envelope will provide a randomisation schedule, patient numbering and a sequence of patient number assignment. This will all be safely stored and secured. The treatment allocation will be communicated to the study therapist/nurse and patient when booking the treatment appointment. It will not be possible to blind the participants or the clinician completing the study treatment. The study examiner will remain blind to treatment allocation.
For treatment stage II (after the 6-month evaluation), only 'non-responders' will be randomised further. Two new randomisation sequences (one for the initial non-surgical arm and one for the initial surgical arm) will be generated by Sealed Envelope for this purpose. If all participants in one treatment group are deemed non-responsive, the maximum number of participants randomised to each treatment arm in treatment stage II will be 5 (assuming no drop-outs or participants lost to follow up).
Non-Surgical Periodontal treatment (NSPT)
Ten participants will be randomised to receive non-surgical periodontal treatment (NSPT). All treatment will be carried out by the same therapist, including oral hygiene. The protocol for NSPT is as follows:
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
Simple randomisation will be completed using the online programme, Sealed Envelope. This will be completed by a member of the research team not involved in this specific study. Sealed Envelope will provide a randomisation schedule, patient numbering and a sequence of patient number assignment. This will all be safely stored and secured. The treatment allocation will be communicated to the study therapist/nurse and patient when booking the treatment appointment. It will not be possible to blind the participants or the clinician completing the study treatment. The study examiner will remain blind to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The following criteria will be considered for inclusion in the study:
- •Age 18-70
- •Diagnosis of Periodontitis stage III or IV, grade A, B or C
- •At least one maxillary or mandibular molars with:
- •Furcation involvement grade III horizontal classification degree B-C vertical classification without any ongoing restorative problems as judged by the study clinician)
- •Probing depth ≥ 6mm
- •Mobility < degree II (as examined by the study clinician)
- •Absence of any ongoing endodontic pathology (as examined by the study clinician)
- •Absence of an adjacent tooth with unfavorable periodontal prognosis (as judged by the study clinician)
- •Non-surgical periodontal therapy performed to the study site within the last 6 months.
- •Able to consent to study participation
- •Exclusion Criteria
- •Smoking (any current or in past 5 years)
- •Medical history including diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases
- •History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- •Anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam
- •Systemic antibiotic therapy during the 3 months preceding the baseline exam
- •History of alcohol or drug abuse
- •. Self-reported pregnancy or lactation
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that according to the investigator may increase the risk associated with trial participation
- •Previous surgical periodontal performed to the study site.
排除标准
- 未提供
结局指标
主要结局
Number of patients
时间窗: 13 months
Number of participants recruited and retained into the study
Probing Pocket Depth (PPD)
时间窗: 13 months
Distance between gingival margin and the bottom of the pocket, measured in mm
patient-reported outcomes (Pros)
时间窗: 13 months
A self-administered questionnaire will be used to assess the patient-reported outcomes (PROS) at 6 and 12 months based on different treatment arms
Bleeding on probing (BOP)
时间窗: 13 months
Bleeding after probing with the periodontal probe the gingival margin, 0 no bleeding 1 bleeding.
Number of responsive and non-responsive
时间窗: 13 months
Number of participants deemed responsive and non-responsive to different treatments. Questionnaire will be used to assess the responsiveness to each treatment.
Number of participants randomised
时间窗: 13 months
Number of participants willing to be randomised to treatment II of the study (if deemed non-responsive following treatment I). Yes or Not answer to randomisation will be used to assess this number.
次要结局
- Microbiological analysis(13 months)