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Endocrowns as Permanent Restorations for Endodontically Treated Permanent Molars in Young Age: Two-Year Follow up

Primary Purpose

Endodontically Treated Teeth, Permanent Molars

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Control group
Endocrown group
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Endodontically Treated Teeth focused on measuring Endocrown,, Monoblock restoration,, Endodontically treated teeth, Young age

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients were systemic free.
  2. Mature lower permanent first molar needs conventional endodontic treatment.
  3. The remaining coronal tooth structure after endodontic treatment is not less than 50%.
  4. Presence of teeth in opposite arch with normal occlusion.
  5. Absence of para-functional habits.
  6. Supra-gingival margin after preparation.
  7. No known allergies.
  8. Complaint patient (parent/ guardians)

Exclusion Criteria:

  1. Immature lower permanent first molar.
  2. Presence of teeth, whose coronal anatomy does not allow use of rubber dam for optimum bonding.
  3. Lack of cooperation of the patients to perform a postoperative radiograph and use a rubber dam for bonding.

Sites / Locations

  • Faculty of Dental Medicine for Girls, Al-Azhar University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Endocrown Group

Arm Description

ProTaper Next rotary system and iRoot SP sealer will be used for root canal treatment, followed by composite restorations.

ProTaper Next rotary system and iRoot SP sealer will be used for root canal treatment, followed by endocrown restorations.

Outcomes

Primary Outcome Measures

Change in marginal adaptation, discoloration and surface of the restoration.
Alpha: No lack of continuity along the margin as observed with the explorer. No pigmentation anywhere on the margin.The surface of the restoration is unaltered. Bravo: Evidence of a crevice along the margin, but the explorer cannot penetrate.Pigmentation present but does not penetrate along the margin toward the pulp. The surface of the restoration shows wear, and must be controlled. Charlie: Evidence of a crevice along the margin, into which an explorer can penetrate. Requires control, repair or retreatment. Severe pigmentation. The restoration must be removed. The surface of the restoration shows perforations, fractures or significant tear. It must be polished, repaired or retreated.

Secondary Outcome Measures

Change in the Retention Status.
Debonding or dislodgement of the restoration.

Full Information

First Posted
August 8, 2020
Last Updated
December 8, 2021
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT04511117
Brief Title
Endocrowns as Permanent Restorations for Endodontically Treated Permanent Molars in Young Age: Two-Year Follow up
Official Title
Endocrowns as Permanent Restorations for Endodontically Treated Permanent Molars in Young Age: Two-Year Follow up
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

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

5. Study Description

Brief Summary
Background: A real challenge faces practitioners in dealing with permanent molars in young patients starting from proper selection of endodontic treatment system till the type of final coronal restoration. For permanent molars in young age patients, which system should be followed to guarantee better performance and enhance the integrity of such weakened teeth? The question most commonly asked. Purpose: To evaluate two-year clinical performance of endocrowns as permanent restorations for endodontically treated molars in young age.
Detailed Description
Endodontic treatment will be done for all patients using ProTaper Next rotary files and iRoot SP sealer. Then patients were randomly divided into two groups; Gr 1: Conventional group (CG), the coronal cavity will be restored directly with bulk-fill nanohybrid composite restorations. Gr 2: Endocrown group (EG), the coronal cavity will be restored with IPS e.max CAD endocrown restorations. First step: Endodontic treatment protocol will be used as the following: Biomechanical preparation using; 2.6% NaOCl for irrigation, ProTaper Next rotary files for instrumentation and 17% EDTA gel for lubrication. Obturation of root canal using; ProTaper gutta-percha and iRoot SP sealer. Second step: Endocrown restoration protocol will be used as the following: Occlusal Butt joint design for Endocrown preparation. Putty-wash technique for taking impression. IPS e.max CAD for Endocrown construction. G-CEM self-adhesive resin cement for Endocrown cementation. Follow up visits: The patients will be recalled every 6 months for evaluation. Evaluation methods: Endodontic treatment evaluation: The outcome will be evaluated clinically and radiographically. Endocrown restoration evaluation: The outcome will be evaluated clinically in terms of; marginal adaptation, marginal discoloration and surface alteration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth, Permanent Molars
Keywords
Endocrown,, Monoblock restoration,, Endodontically treated teeth, Young age

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control group: the patient will receive direct composite resin restorations. Endocrown group: the patient will receive endocrown restorations.
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
ProTaper Next rotary system and iRoot SP sealer will be used for root canal treatment, followed by composite restorations.
Arm Title
Endocrown Group
Arm Type
Experimental
Arm Description
ProTaper Next rotary system and iRoot SP sealer will be used for root canal treatment, followed by endocrown restorations.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
ProTaper Next rotary system and iRoot SP sealer with composite restorations.
Intervention Type
Other
Intervention Name(s)
Endocrown group
Intervention Description
ProTaper Next rotary system and iRoot SP sealer with endocrown restorations.
Primary Outcome Measure Information:
Title
Change in marginal adaptation, discoloration and surface of the restoration.
Description
Alpha: No lack of continuity along the margin as observed with the explorer. No pigmentation anywhere on the margin.The surface of the restoration is unaltered. Bravo: Evidence of a crevice along the margin, but the explorer cannot penetrate.Pigmentation present but does not penetrate along the margin toward the pulp. The surface of the restoration shows wear, and must be controlled. Charlie: Evidence of a crevice along the margin, into which an explorer can penetrate. Requires control, repair or retreatment. Severe pigmentation. The restoration must be removed. The surface of the restoration shows perforations, fractures or significant tear. It must be polished, repaired or retreated.
Time Frame
At 6 months, 12 months, 18 months, and 24 months following application.
Secondary Outcome Measure Information:
Title
Change in the Retention Status.
Description
Debonding or dislodgement of the restoration.
Time Frame
At 6 months, 12 months, 18 months, and 24 months following application.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients were systemic free. Mature lower permanent first molar needs conventional endodontic treatment. The remaining coronal tooth structure after endodontic treatment is not less than 50%. Presence of teeth in opposite arch with normal occlusion. Absence of para-functional habits. Supra-gingival margin after preparation. No known allergies. Complaint patient (parent/ guardians) Exclusion Criteria: Immature lower permanent first molar. Presence of teeth, whose coronal anatomy does not allow use of rubber dam for optimum bonding. Lack of cooperation of the patients to perform a postoperative radiograph and use a rubber dam for bonding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roqaia M Alassar, DDS
Organizational Affiliation
Fixed Prosthodontist, Faculty of Dental Medicine for Girls, Al-Azhar University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heba Abdelkafy, DDS
Organizational Affiliation
Endodontist, Faculty of Dental Medicine for Girls, Al-Azhar University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eman Abdelraouf, DDS
Organizational Affiliation
Pedodontist, Faculty of Dental Medicine for Girls, Al-Azhar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dental Medicine for Girls, Al-Azhar University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Endocrowns as Permanent Restorations for Endodontically Treated Permanent Molars in Young Age: Two-Year Follow up

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