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

Primary Purpose

Endodontically Treated Teeth

Status
Active
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Direct composite resin restoration
Direct composite resin restoration followed by full coverage metal ceramic crown
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontically Treated Teeth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

- Patients under 18

Sites / Locations

  • University of Jordan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Direct composite resin restoration

Full coverage metal-ceramic crown

Arm Description

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

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

Outcomes

Primary Outcome Measures

Survival
Survival of the tooth and restoration
Success
Success of the restoration without complications: to be assessed based on modified USPHS criteria (margin integrity, color, surface texture)
Complications
Complications that affect the restoration
Patient reported satisfaction
Patients' reported satisfaction with the restoration provided regarding: appearance, function, ease of cleaning and cost using the visual analog scale.

Secondary Outcome Measures

Full Information

First Posted
January 24, 2020
Last Updated
July 1, 2023
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT04249726
Brief Title
The Restoration of Endodontically Treated Teeth Using Indirect Full Coverage Restorations Compared to Direct Composite Resin Restorations
Official Title
The Restoration of Minimally Destructed Posterior Endodontically Treated Teeth Using Indirect Full Coverage Restorations Compared to Direct Composite Resin Restorations: A Randomised Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The management of posterior endodontically treated teeth (ETT) is still to this day considered a controversial topic.The use of full cuspal coverage restoration for the management ETT 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. An ETT tooth with an MOD cavity will be at a higher risk of fracture than an ETT tooth with just an occlusal cavity. Managing both with cuspal coverage could be considered an overtreatment and an unnecessary removal of tooth structure. 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 an ETT 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 ETT 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. The groups are: Group 1: Managed with direct intracoronal composite resin restoration. Group 2: Managed with a direct composite resin restoration, followed by an indirect full coverage restoration. Patients will be recalled at 1 year, 3 years and 5 years. Treatment protocol for each group Group 1: Patient receiving a composite resin restoration. Following rubber dam isolation, the temporary restoration will be removed. The enamel will be selectively etched with 37% phosphoric acid and rinsed and dried thoroughly till a white frost appearance appeared. An adhesive system (ScotchBond Multi-Purpose - 3M ESPE) will then be applied to the dentine according to the manufacturer instructions and then will be cured for 30 seconds. The direct restoration will be made using a microhybrid resin composite (Filtek Z350, 3M ESPE), which will be applied in increments and each increment cured for 40 seconds. Glycerin will be applied to the final restoration and cured for 5 seconds to prevent the development of the oxygen inhibition layer. The restoration will then be finished with ultra-fine diamond finishing burs, and polished with Sof-Lex discs (3M ESPE) and 0.1 micrometer particle size diamond paste. Occlusion will be checked to conform to the patient's current occlusion status and make sure no interferences were introduced. Group 2: Patients receiving a composite resin restoration and followed with an indirect full coverage restoration. The same steps used as for group 1 would be followed to build the composite resin core. This will be followed with a preparation for the indirect full cuspal restoration. Three additional silicone putty indices will be made; one will be made for the production of a provisional crown, and the other two will be cut and used as reduction indices (one will be cut mesio-distally and the other one will be cut facially-lingually/palatally). The preparation will be carried out with diamond burs. The guidelines to be followed will include: Supra or equigingival margins if aesthetic was of concern. Chamfer finish-line 2 mm occlusal reduction; 1.5 mm axial reduction all around Following the application of two double retraction cord sizes 00 and 0 (Ultradent), the impression will be made with additional silicone (Zermack) and the cast poured in Die stone. The crown will be fabricated in the laboratory. The temporary crown made from self-cure bisacrylic (Protemp, 3M ESPE) would be cemented using Eugenol free temporary crown and bridge cement (TempBond). All crowns will be cemented after 1 week using Resin modified glass ionomer cement (RelyX luting plus, 3M ESPE). Follow-up appointments and data Collection Clinical evaluation will include: Visual inspection conducted with loops at magnification 4.5 Examination of the continuity of the margins of the restoration with the tooth structure by use of an explorer Periodontal probing performed with a periodontal probe. Color photos (1:1 mirror shots) of the restorations were taken with standard film Periapical and bitewing radiographic examination was performed by use of a paralleling technique at 65 kV and 8 mA. Patients reported outcome measures (PROM) Evaluation of success or failure will be performed by 2 examiners other than the operator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups parallel to each other randomly assigned to a specific intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Direct composite resin restoration
Arm Type
Experimental
Arm Description
Root filled teeth with occlusal cavities and at least 3 intact axial walls will receive composite resin restorations
Arm Title
Full coverage metal-ceramic crown
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Direct composite resin restoration
Other Intervention Name(s)
Intracoronal restoration
Intervention Description
A direct composite resin restoration will be provided intracoronally without cuspal coverage.
Intervention Type
Procedure
Intervention Name(s)
Direct composite resin restoration followed by full coverage metal ceramic crown
Other Intervention Name(s)
Full coverage metal-ceramic crown
Intervention Description
A direct composite resin restoration will be provided intracoronally followed by a full cuspal coverage metal ceramic crown.
Primary Outcome Measure Information:
Title
Survival
Description
Survival of the tooth and restoration
Time Frame
5 years
Title
Success
Description
Success of the restoration without complications: to be assessed based on modified USPHS criteria (margin integrity, color, surface texture)
Time Frame
5 years
Title
Complications
Description
Complications that affect the restoration
Time Frame
5 years
Title
Patient reported satisfaction
Description
Patients' reported satisfaction with the restoration provided regarding: appearance, function, ease of cleaning and cost using the visual analog scale.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: - Patients under 18
Facility Information:
Facility Name
University of Jordan Hospital
City
Amman
ZIP/Postal Code
11942
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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