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临床试验/NCT04561167
NCT04561167已完成不适用

Clinical Performance of the Indirect Resin Composite Restorations in Endodontically Treated Teeth With Different Cavity Preparation Designs: (A Randomized Clinical Trial)

Cairo University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Marginal adaptation

研究概览

简要总结

Does the cuspal reduction during cavity preparation for indirect resin composite restorations in endodontically treated teeth increase the clinical performance when compared to cavities prepared without cuspal reduction?

详细描述

Selection and examination of the all patients will be done according to inclusion and exclusion criteria( by Hoda omar fouda in the Faculty of Dentistry Cairo University, Egypt ) from the outpatient clinic of the conservative department of the faculty of oral and dental medicine , cairo university .Patients should have an endodontically treated molar with remaining three walls fulfilling the inclusion criteria of the selected teeth or patients who need root canal treatment to be done prior to restoration to be enrolled in the study. Root canal treatment for all patients will be done by step back technique using rotary files .Sodium hypochlorite and EDTA solution will be used as root canal irrigant solution. Root canals will be obturated with gutta percha cones using AH Plus (Dentsply, Konstanz Germany). Eugenol based sealers will avoided to avoid the contamination of the remaining walls with eugenol that can interfere with the polymerization of the adhesive.

Eugenol free temporary filling material (Coltosol F by Coltene, Switzerland) will be used to seal the cavity till the restorative visit A digital periapical radiograph will be done to check the quality of the root canal treatment. The selected tooth should be free from any periapical radiolucency, missed canals or poor obturation. The periodontal condition of the tooth will be also checked radiographically. The tooth should be free from any clinical symptoms as pain on biting or swelling. A period not more than a month should pass from the root canal treatment to avoid any coronal leakage that might affect the prognosis of the root canal treatment during the time of the study. Any defects in the temporary filling material should be restored again to assure proper coronal seal till the beginning of the treatment. Before the removal of the temporary filling, assessment of centric and eccentric occlusal contacts will be performed with an articulating paper. The tooth should be then checked for the contact points in the centric relation and eccentric movements It is important to determine the contact points during the centric and eccentric movements to maintain the tooth restoration interface at a stress free areas as much as possible for more durable bonding. The quadrant with the cavity will be isolated using rubber dam system with two suctions tips one below the rubber dam sheet and the other one near to the tooth to keep the working area always clean and keep the patient comfortable during the procedures. Using straight and round blue coded diamond stones attached to high speed handpiece with copious air and water coolant, the temporary filling will be removed from the cavity. The cavity should then be checked for any remaining carious lesions to be removed. All the undermined enamel walls should be removed so that all the remaining cavity walls have well supported sound enamel margins. Any soft carious lesions will be by a sharp spoon excavator. Any gutta-percha remnants in the pulp chamber should be removed till the gutta percha becomes at the level of the orifice and all the walls and floor are completely clean. All the procedures will be performed with magnifying loupes 3.5 x (Univet, Italy). The angulation of the cavity walls will be adjusted to be 6 degrees diverge of the axial inclination using blue coded diamond tapered with round end bur diameter 16, length 10.

Standardization of the prepared cavity dimensions should be done as follows:

  1. For the inlay group thickness of remaining walls (in order to maintain them) has to be 1.5 mm.
  2. The occlusal inter-cuspal distance ranges from 4-5 mm

4- Width of occlusal isthmus had to be 2-3 mm. 5- Buccal and lingual walls of the proximal parts of the cavity will be prepared using the same diamond bur (MIDWEST Dentsply) used for the occlusal part of the cavity to provide the same angle of divergence (6 degrees) as that of the occlusal walls. 6- The proximal boxes corresponds to one-third the distance between the buccal and lingual surfaces of the teeth 7- The gingival floor of the proximal part of the cavity has to be continuous with the pulpal floor of the occlusal part having the same depth. 8- Interproximal overjet has to be ≤ 2 mm. 9- The internal line angles should be rounded, the cavo-surface angles should be 90° For the Intervention Group: no cuspal reduction will be done as these will be the cavities prepared to receive the inlay restorations For the Comparator Group: cuspal reduction to buccal and lingual cusps will be done as these will be the cavities prepared to receive the onlay restorations

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Only co-operative patients approving to participate in the trial.
  • Good oral hygiene.
  • Medically free adult patients.
  • The age range of the patients is 13-18 years
  • Patients havind Endodontically treated molars with remaining two walls.
  • Teeth with no periapical lesion or radiolucency.
  • Root canal treatment finished from maximum two weeks with no clinical symptoms.
  • Prepared cavity with no undermined enamel walls.
  • The thickness of the remaining walls not less than 2 mm.
  • Functioning tooth with presence of an opposing.
  • Healthy periodontium

排除标准

  • Old age patients.
  • Patients with disabilities.
  • Patients having systemic diseases or severe medically compromised.
  • Patients with of severe bruxism, clenching or temporomandibular joint disorders.
  • Poor oral hygiene.
  • Teeth with severe dilacerations.
  • Teeth with periapical lesions.
  • Teeth with visible cracks.
  • Teeth with internal or external root resorption.
  • Teeth with calcified root canals.
  • Teeth with mobility.
  • Teeth with undermined enamel walls.
  • Non-functioning tooth with no opposing tooth.
  • Heavy occlusion or signs of severe attrition.
  • Severe periodontal affection.

结局指标

主要结局

Marginal adaptation

时间窗: 12 months

Visual inspection with explorer and mirror by measuring the distance penetrated by the explorer at the tooth restoration interface. The explorer will be drawn across the surface of the restoration toward the tooth

次要结局

  • Anatomic Form(12 months)
  • Retention(12 months)
  • Fracture of tooth and /or restoration(12 months)
  • Color Match(12 months)
  • Surface texture(12 months)
  • post operative sensitivity(12 months)
  • Secondary Caries(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

hoda omar tawfeek hussien fouda

The principle investigator

Cairo University

研究点 (2)

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