Clinical Evaluation of Two Post Systems for Single Crown Restoration of Anterior Teeth: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Post-Gutta-Percha Gap Distance
研究概览
简要总结
This randomized controlled trial evaluates two post systems used to restore endodontically treated (root canal treated) maxillary anterior teeth with 1-2 missing coronal walls. Participants will be randomly assigned to receive either a custom-adapted polyethylene fibers post (Ribbond-type, individually formed) or a prefabricated fiber post, followed by a composite core and crown restoration. The primary outcome is the distance between the post and the remaining root canal filling (gutta-percha), measured radiographically, which reflects how well the post adapts within the canal. The secondary outcome is post and restoration retention, assessed clinically using USPHS criteria. Participants will be followed for 6 months. The study aims to determine whether a custom-fitted fiber post provides better adaptation and retention compared to a standard prefabricated fiber post in teeth with significant structural loss.
详细描述
Endodontically treated maxillary anterior teeth frequently present with significant loss of coronal tooth structure, compromising their resistance to fracture and complicating restoration. prefabricated fiber posts are widely used to retain a composite core prior to crown placement, but the degree to which a post adapts to the internal canal wall - leaving minimal or no gap between the post and the remaining gutta-percha - may influence long-term clinical performance and resistance to microleakage.
This study is a randomized controlled trial comparing a custom-adapted ultra-high-molecular-weight polyethylene (UHMWPE) fibers post (Ribbond-type), individually formed to the canal anatomy, against a prefabricated fiber post. Eligible teeth are endodontically treated maxillary anterior teeth with 1-2 missing coronal axial walls (mesial, distal, labial, and/or palatal), assessed at the cementoenamel junction, where any remaining sound walls meet a minimum height of 1.5-2 mm and a circumferential thickness of approximately 1 mm, in line with established ferrule criteria.
Participants will be randomly allocated to receive either the Ribbond post or the prefabricated fiber post, followed by a standardized composite core build-up and definitive crown restoration. Post space preparation, dentin conditioning, and cementation will follow a standardized step-by-step clinical protocol for each group.
The primary outcome is the post-gutta-percha gap distance, measured radiographically and expressed continuously in millimeters, with cases additionally classified as showing no gap versus any measurable gap. This dichotomization and its expected baseline distribution are informed by prior clinical data reporting outcomes in maxillary anterior teeth. The secondary outcome is post and restoration retention, evaluated clinically at follow-up using USPHS criteria.
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
- Single (Participant)
盲法说明
the biostatistician will be blinded
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Endodontically treated maxillary anterior teeth (incisors and/or canines)
- •Presence of 1-2 missing coronal axial walls (mesial, distal, labial, and/or palatal), assessed at the cementoenamel junction (CEJ)
- •Remaining sound tooth structure meeting minimum ferrule criteria: wall height ≥1.5-2 mm and circumferential thickness ≈1 mm
- •Adequate root canal filling with no radiographic signs of periapical pathology
- •Root length and canal morphology suitable for post space preparation
- •Patients aged 20-40 years
- •Willing and able to provide informed consent and attend follow-up visits
排除标准
- •Teeth with 3 or more missing coronal axial walls (insufficient ferrule)
- •Evidence of active periapical pathology, root fracture, or root resorption
- •Insufficient remaining root length for adequate post retention
- •Signs of periodontal disease affecting tooth prognosis (e.g., mobility, inadequate periodontal support)
- •Systemic conditions contraindicating routine dental treatment
- •Pregnancy (if radiographic follow-up is required)
- •Inability to attend scheduled follow-up visits
研究组 & 干预措施
Prefabricated Fiber Post with Composite Core
Participants receive a prefabricated fiber post, followed by a composite core build-up and definitive crown restoration.
干预措施: Custom-Fit UHMWPE Fiber Post with Composite Core (Other)
Custom-Fit UHMWPE Fiber Post with Composite Core
Participants receive a custom-fit UHMWPE fiber post, individually adapted to the canal at chairside, followed by a composite core build-up and definitive crown restoration.
干预措施: Custom-Fit UHMWPE Fiber Post with Composite Core (Other)
结局指标
主要结局
Post-Gutta-Percha Gap Distance
时间窗: Immediately post-cementation (baseline)
Distance between the outer surface of the cemented post and the residual root canal filling (gutta-percha), measured radiographically at the coronal, middle, and apical thirds of the post space. Reported both as a continuous measurement (mm) and dichotomized as no gap versus any measurable gap.
次要结局
- Post and Restoration Retention(6 months post-cementation)
研究者
Mohamed el sayed bekhiet
Assistant lecturer - Fixed prosthodontic department- Faculty of oral and dental medicine
Cairo University