Clinical Performance of the Indirect Resin Composite Restorations in Endodontically Treated Teeth

NCT04561167 | Completed DMC

• 1 other identifier: Egameel43
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Endodontically Treated Teeth

Outcome Measures

Primary Outcomes (1)

• Marginal adaptation

  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

  12 months

Secondary Outcomes (7)

• Fracture of tooth and /or restoration

  12 months

• Anatomic Form

  12 months

• Surface texture

  12 months

• post operative sensitivity

  12 months

• Retention

  12 months

Study Arms (2)

Cuspal reduction in MOD Cavity in endodontically treated teeth

EXPERIMENTAL

Cavity design is of prime importance for the restoration of endodontically treated teeth. The cavity design plays an important role in the protection of the remaining tooth structure as well as the restoration. Cuspal reducuction and further coverage by the CAD/CAM generated indirect resin composite restoration has been proved in literature by the retrospective study done by (Chrepa V et al 2014) which studied 189 posterior endodontically treated teeth receiving indirect composite onlays with a median follow up time of 37 months and suggested this type of restoration as a viable option with 100% tooth survival and 96.8% restoration survival.

Other: Cuspal reduction in MOD cavity in endodontically treated teeth

No cuspal reduction in endodontically treated teeth

ACTIVE COMPARATOR

In the present study, choosing the comparator to be the cavity design without cuspal reduction and further coverage (inlay) is done as an attempt to reduce the application of inlays in endodontically treated teeth. In accordance to the in-vitro study done by (M. D. Al Amri et al 2016) which tested the fracture resistance of endodontically treated mandibular first molars with conservative access cavity and different restorative techniques, catastrophic failures were highest in the composite group (100%), followed by the inlay and the amalgam groups (91.67%) and this was referred to the adhesive bonding mechanism of the composite restoration and the wedging effect of the inlay and the amalgam restorations (Rivera EM andWalton RE 2015)

Other: No cuspal reduction in MOD cavity in endodontically treated teeth

Interventions

Cuspal reduction in MOD cavity in endodontically treated teeth OTHER

Not only the quality of endodontic treatment that affects the prognosis of the endodontically treated tooth, but the subsequent restorative treatment as well. Coverage, Endocrowns, Onlays, Inlays Restorations on Fracture Resistance of Endodontically Treated Molars, it was found that the worst results came to the inlay restorations and this was attributed to geometric form of preparation that exert a wedging force acting to split the tooth when under occlual stress however, onlay and full coverage direct the force along the long axis by overlaying the cusp tips and a portion of buccal and lingual surface thus opposing the wedging action created by internal design of restoration (Magne P and Belser C. et al 2003) That's why, choosing such a design as a comparator to the design of the cuspal reduction and further coverage (onlay) is crucial to show the importance of cuspal coverage for the indirect resin composite restoration in the endodontically treated teeth.

Cuspal reduction in MOD Cavity in endodontically treated teeth

No cuspal reduction in MOD cavity in endodontically treated teeth OTHER

In an invitro study done by (Ahmed Hamdy 2015) investigating the effect of Full The amount of lost internal tooth structure as well as the coronal hard tissue in an endodontically treated tooth is considered the main factors that make the tooth susceptible to biomechanical failure when compared to a vital tooth. (Guo J et al 2016) .

No cuspal reduction in endodontically treated teeth

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hoda omar fouda

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Hoda Fouda, master

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The principle investigator

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: September 23, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: expecting to have all the data during october 2022
• Access Criteria: IPD through contacting the main author Hoda.fouda@bue.edu.eg

Locations

EG (1)