Open, Randomized Multicentric Trial Evaluating the Efficacy and the Clinical Tolerance of PA0903 as Root Canal Sealer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- clinical and radiographic outcome of PA0903 as root canal sealer
研究概览
简要总结
TRIAL TITLE: Open, randomized multicentric trial evaluating the efficacy and the clinical tolerance of PA0903 as root canal sealer
SPONSOR:
SEPTODONT, 58 rue du Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33 1-49-76-74-26, Fax. : + 33 1- 49-76-71-91
Reference protocol: 11/001
PRODUCT NAME: PA0903
MEDICAL DEVICE:
Class III: Root canal sealer Dose: not applicable Application : one single time
DEVELOPMENTAL PHASE: not applicable (medical device class III)
详细描述
METHODOLOGY:
This study is performed only in adults who required a non-surgical root canal obturation. The studied indication is the root canal sealing.
This multi-centre and open-label study comprises two groups corresponding to tested root canal sealer (a reference product and investigational product). Randomization is required.
Investigational product that is a dental cement based on biosilicate technology (PA0903) will be applied with lateral compaction or single cone technique. On the contrary, reference product that is a zinc oxide-eugenol used in dental practice (Pulp Canal Sealer) will be applied with a single wave technique.
Study start: 01/12/11
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female >18 years old
- •provide signed, informed consent.
- •be affiliated to social security.
- •In addition, the subjects must fulfill all of the following criteria for root canal sealer treatment:
- •Permanent mature single rooted teeth : maxillary incisors, mandibular incisor with only one canal, upper and lower canine, upper and lower premolars with only one canal
- •Permanent mature mandibular molars Pulp status
- •Vital pulp that needs pulpectomy without clinical and/or radiological findings of apical periodontitis.
- •Irreversible pulpitis with or without pain
- •Non infected tooth that positively responds of pulp vitality test Or necrotic pulp with and without radiographic signs of apical pathosis Periodontal status
- •No active periodontal disease
排除标准
- •History of malignancy in the last 5 years.
- •Systemic disease not stabilized within 1 month before the Inclusion Visit (e.g., diabetes, thyroid malfunction, uncontrolled autoimmune disease) or judged by the investigator to be incompatible with the study (e.g. current systemic infections) or condition incompatible with the frequent assessments needed by the study.
- •Risk A cardiopathies
- •Known hypersensitivity to one of the components of the study or procedural medications.
- •Presence or history of severe systemic allergy.
- •Presence or history of drug addiction or alcohol abuse.
- •Patient who has participated in a clinical trial with a new active substance during the month before study entry.
- •Participation in another clinical study at the same time as the present study.
- •Known pregnancy or lactation at study entry.
- •Patients with legal protection
- •Specific criteria relative to root canal sealing are:
- •Extreme curvature of the canals
- •Dilacerations
- •Root dilacerations and sharp apical curvature for mandibular molars
- •Superimposition of mesial canals for mandibular molar
- •Large peri-apical radiolucencies
- •Periodontal disease
- •Not primary endodontic treatment
- •Perforated root canals
- •Supracrestal iatrogenic perforation
- •Inadequate or insufficient periodontal support
- •Combined endo-periodontal lesion
- •Loss of tooth structure (Coronal decay and/or concomitant root decay) compromising the tooth's maintenance on the dental arch)
结局指标
主要结局
clinical and radiographic outcome of PA0903 as root canal sealer
时间窗: 2 years
to evaluate clinical and radiographic outcome of root canal treatment at two years when using PA0903 as an endodontic sealer with gutta-percha. The success rate is defined as no pain (score of 0 at the VAS scale) and absence or decrease in the size of LEO (fulfilment of Strindberg's criteria). If a pre-existing lesion, the size decrease associated with normal contours, width and structure of the periodontal margines is considered as success. All cases in which lesion increases or is stabilized after 2 years were judged as unsuccessful .A follow-up of two years is described as the predictive time of success.
次要结局
- Secondary outcomes(2 years)