The Restoration of Endodontically Treated Teeth Using Indirect Full Coverage Restorations Compared to Direct Composite Resin Restorations

NCT04249726 | Unknown

• 1 other identifier: UJordan1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The use of full cuspal coverage restoration for the management root treated teeth was advocated by many clinical studies and supported by systematic reviews. However, most of the studies did not take into account the amount of tooth structure remaining before providing cuspal coverage. The strength and fracture resistance of the tooth has been shown to be positively correlated with the amount of tooth structure remaining. A more conservative treatment option could be selected for a root treated tooth with good amount of remaining tooth structure such as direct restorations. The aims of this randomized clinical trial is to compare the survival and success of root treated teeth with occlusal cavities and at least three intact axial walls, when restored through the use of indirect full cuspal coverage restorations vs direct composite resin restorations.

Conditions

Endodontically Treated Teeth

Outcome Measures

Primary Outcomes (4)

• Survival

  Survival of the tooth and restoration

  5 years

• Success

  Success of the restoration without complications: to be assessed based on modified USPHS criteria (margin integrity, color, surface texture)

  5 years

• Complications

  Complications that affect the restoration

  5 years

• Patient reported satisfaction

  Patients' reported satisfaction with the restoration provided regarding: appearance, function, ease of cleaning and cost using the visual analog scale.

  5 years

Study Arms (2)

Direct composite resin restoration

EXPERIMENTAL

Root filled teeth with occlusal cavities and at least 3 intact axial walls will receive composite resin restorations

Procedure: Direct composite resin restoration

Full coverage metal-ceramic crown

ACTIVE COMPARATOR

Root filled teeth with occlusal cavities and at least 3 intact axial walls will receive composite resin restorations followed by full coverage metal-ceramic crown

Procedure: Direct composite resin restoration followed by full coverage metal ceramic crown

Interventions

Direct composite resin restoration PROCEDURE

A direct composite resin restoration will be provided intracoronally without cuspal coverage.

Also known as: Intracoronal restoration

Direct composite resin restoration

Direct composite resin restoration followed by full coverage metal ceramic crown PROCEDURE

A direct composite resin restoration will be provided intracoronally followed by a full cuspal coverage metal ceramic crown.

Also known as: Full coverage metal-ceramic crown

Full coverage metal-ceramic crown

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To have at least one posterior tooth in need for root canal treatment and restoration.
• The tooth structure loss of the tooth should be limited to an occlusal cavity with at least three remaining axial walls (\>2mm thickness).
• The tooth should be opposed by a natural tooth or a fixed partial denture.
• The tooth should not be serving as an abutment for a removal or fixed partial denture.

You may not qualify if:

• \- Patients under 18

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

University of Jordan Hospital

Amman, 11942, Jordan

Location

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two groups parallel to each other randomly assigned to a specific intervention.

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 31, 2020
• Study Start: January 25, 2019
• Primary Completion: January 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 5, 2023

Record last verified: 2023-07

Locations

JO (1)