Clinical trial NCT04518371: Clinical Performance of Milled Resin Composite in Restoration of Endodontically Treated Posterior Teeth Over One Year
Official title: Clinical Performance and Wear Resistance of Milled Resin Composite Material Versus Direct Nanohybrid Bulk-Fill Resin Composite in Restoration of Endodontically Treated Posterior Teeth Over One Year: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endodontically Treated Teeth
Keywords: Endodontically Treated Teeth
Milled Composite
Clinical Performance
Occlusal Wear
IntraOral Scanner
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 32
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients with endodontically treated teeth, will the Indirect Milled composite Endo-crown restorations have a better clinical performance and more wear resistance than the Direct Bulk-Fill resin composite restorations over one year?

Primary Objective: To evaluate clinical performance of different Techniques of Composite Restorations (Indirect restorations using a CAD/CAM grinding process, BRILLIANT Crios, Coltène/Whaledent AG, Switzerland or Direct a light-cured, bulk-fill nanocomposite restorative material, Filtek™ One Bulk Fill Restorative, 3M ESPE Dental Products, USA) in Endodontically treated posterior teeth.

Detailed description: The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University; The operator in charge will be Esraa Esmeail Hussien.

Null-hypothesis: There are no differences in the clinical performance of indirect CAD/CAM milled composite when compared to direct bulk-fil composite endocrowns when in the posterior area.

Aim: This clinical trial will be conducted to assess the clinical performance of using indirect Milled composite or direct bulk-fill resin composite Endo-crowns for restoring the endo-treated teeth, as well to measure the amount of wear on the occlusal tables of both restorations using Digital Scanner.

Patients will be selected from the outpatient clinic of the department Conservative Dentistry Department, Faculty of Dentistry, Cairo University

Clinical Steps:

* A tapered stone with rounded end in a high-speed handpiece with air /water coolant will be used to properly prepare the cavity walls to receive the indirect restoration and any remaining carious dentin will be excavated and removed.
* Cuspal tipping will be done by a wheel stone about 1.5-2mm.
* The entrance to the pulpal canal will be opened. Gutta percha will be removed to a depth not exceeding 2 mm to take advantage of the saddle-like anatomy of the cavity floor. This should be done with a nonabrasive instrument to maintain the integrity of the canal's entrance. No drilling into the dentin will be carried out.
* Any remaining undercuts will be blocked with conventional resin composite.
* The impression will be taken, and the final restoration will be fabricated either direct or indirect.
* The final restoration should be checked intraorally for proximal contacts, occlusion and marginal fit before cementation.
* Isolation of operatory field using rubber dam.
* Selective enamel etching technique will be applied for bonding of tooth structure, 35-40% phosphoric acid gel will be applied to the enamel margins only for 15 seconds, rinsed for 15 seconds and gently dried by cotton pellet.
* Adhesive will be used according to the manufacturers' instructions.
* Adhesive resin cement will be applied into the preparation. The restoration will be placed in the cavity and checked for complete seating. The cement will be light cured for only 2 seconds to facilitate removal of the excess. Then light curing will be done from all directions each for 40 seconds for achieving the final set.
* The proximal contacts will be checked with dental floss.
* The occlusion will be adjusted using articulating paper.
* Finishing and Polishing using finishing stones and polishing rubber points.

Primary Objective: To evaluate clinical performance of different Techniques of Composite Restorations (Indirect restorations using a CAD/CAM grinding process, BRILLIANT Crios, Coltène/Whaledent AG, Switzerland or Direct a light-cured, bulk-fill nanocomposite restorative material, Filtek™ One Bulk Fill Restorative, 3M ESPE Dental Products, USA) in Endodontically treated posterior teeth.

Eligibility criteria: Inclusion Criteria of participants:

* Patients with asymptomatic endodontically treated molars.
* Males or Females.
* Good oral hygiene.
* Co-operative patients approving to participate in the study.

Inclusion Criteria of teeth:

* Asymptomatic endodontically treated upper or lower molars with
* Homogenous root canal filling ending 1-2mm from the radiographic apex.
* Proximal compound cavities.
* Favorable occlusion.

Exclusion criteria of participants:

* High caries index with poor oral hygiene.
* Severe medical complications.
* Pregnancy.
* Allergic history concerning methacrylates Disabilities.
* Heavy smoking.
* Xerostomia.
* Lack of compliance.
* Evidence of parafunctional habits.
* Temporomandibular joint disorders.

Exclusion criteria of the teeth:

* Teeth with remaining wall thickness less than 1mm.
* Teeth with improper or symptomatic endodontic treatment.
* Deep subgingival cavity margins.
* Possible future prosthodontic restoration of teeth.
* Severe periodontal problems.

Primary outcomes:
measure: Degree of Continuity between natural tooth structure and the restoration
timeFrame: Immediately after procedure
measure: Degree of Continuity between natural tooth structure and the restoration
timeFrame: 6 months
measure: Degree of Continuity between natural tooth structure and the restoration
timeFrame: 12 months
Secondary outcomes:
measure: The degree of mismatch from the normal range of tooth shades and translucency
timeFrame: Immediately after procedure
measure: The degree of mismatch from the normal range of tooth shades and translucency
timeFrame: 6 months
measure: The degree of mismatch from the normal range of tooth shades and translucency
timeFrame: 12 months
measure: Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
timeFrame: Immediately after procedure
measure: Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
timeFrame: 6 months
measure: Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins
timeFrame: 12 months
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
timeFrame: Immediately after procedure
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
timeFrame: 6 months
measure: Pain due to dentin hypersensitivity (evaporative stimulus)
timeFrame: 12 months
measure: Area of continuous movement of an explorer across the surface of the restoration
timeFrame: Immediately after procedure
measure: Area of continuous movement of an explorer across the surface of the restoration
timeFrame: 6 months
measure: Area of continuous movement of an explorer across the surface of the restoration
timeFrame: 12 months
measure: Distance penetrated by the Explorer at the tooth restoration interface
timeFrame: Immediately after procedure
measure: Distance penetrated by the Explorer at the tooth restoration interface
timeFrame: 6 months
measure: Distance penetrated by the Explorer at the tooth restoration interface
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Esraa Es Hussien
role: PRINCIPAL_INVESTIGATOR
References: