Clinical Performance of Injection-molded Co-cured Bulk-fill Composite Restorations Compared to Incrementally-packed Conventional Resin Composite in Proximal Cavities of Posterior Permanent Teeth: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Marginal integrity using a 150- and 250- micron width special probe tip
研究概览
简要总结
The clinical performance of 2 bonding and composite packing techniques in the proximal cavities of permanent posterior teeth will be assessed. Incremental packing with pre-curing of universal adhesive in selective etching mode is compared to injection molding of preheated composing co-cured with universal adhesive in selective-etch.
Main outcomes will focus on marginal integrity, post-operative hypersensitivity, and contact form and tightness.
详细描述
Aim of the study: To evaluate the clinical performance in terms of marginal integrity, contact tightness and form, and post-operative hypersensitivity of injection-molded co-cured bulk-fill composite versus incrementally-packed composite in proximal cavities of permanent posterior teeth.
PICOTS:
P: Population: Adult patients with carious posterior molars requiring moderate-sized proximal composite restorations I: Intervention: Injection-molding technique using co-cured bulk-fill composite resin C: Comparator: Conventional incrementally-packed resin composite O: Outcome: Primary Outcome: Marginal integrity of examined restorations; Secondary Outcomes: Post- operative hypersensitivity and contact tightness of examined restorations T: Time: Restorations will be evaluated at baseline (T0), 6 (T1), 12 (T2), 24 (T3) and 36 (T4) months. Post-operative hypersensitivity will be evaluated at 48 hours and at baseline (one week).
S: Study design: Prospective randomized controlled clinical trial (RCT): parallel, equivalence trial with 1:1 allocation ratio
Research Hypothesis:
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 (Outcomes Assessor)
盲法说明
Assessors and statistician are blinded for the type of restoration placed
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a minimum of one proximal carious lesion in a maxillary or mandibular posterior tooth
- •Selected teeth should have not more than one proximal carious lesion
- •Caries should be extending not more than the outer third of dentin in pre-operative radiograph
- •Presence of antagonist and adjacent teeth for selected molars
- •Vital teeth with no signs or symptoms of pulpitis
- •Anticipated cavity external walls should be in enamel
- •Normal periodontal status and good oral hygiene
- •Mobility grade ≤ 1
- •Good general health
排除标准
- •Patients with occlusal, buccal or lingual caries lesions in selected teeth
- •Two proximal cavities in selected teeth
- •Extensive carious lesions; shallow enamel lesions or old restorations
- •Absence of antagonist or adjacent teeth
- •Non-vital, hyperemic or endo-treated teeth
- •Cavities requiring gingival margin relocation or pulp capping (direct or indirect)
- •Chronic or acute periodontitis
- •Mobility grade 2 or 3
- •>50 and <18 Years old
- •Systemic conditions, allergy to restorative materials and hospitalized patients
- •Evidence of bruxism and temporomandibular joint disorders
- •Patients with low compliance potential
结局指标
主要结局
Marginal integrity using a 150- and 250- micron width special probe tip
时间窗: 36 months
gap width at tooth-restoration interface
次要结局
- Post-Operative hypersensitivity: using Visual Analog Scale 0-10 (VAS). Zero: no pain; 10: unbearable pain.(48 hours and one week)
- Contact tightness: gap width between proximal teeth surfaces. Using a 25-micron dental floss, and 50- and 100- micron metal blade(36 months)
研究者
Ahmed GS Zaghloul
Principal investigator
Cairo University