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

NCT04511117 | Completed

• 1 other identifier: PD-P-019-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontically Treated Teeth; Permanent Molars

Keywords

Endocrown,; Monoblock restoration,; Endodontically treated teeth; Young age

Outcome Measures

Primary Outcomes (1)

• 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.

  At 6 months, 12 months, 18 months, and 24 months following application.

Secondary Outcomes (1)

• Change in the Retention Status.

  At 6 months, 12 months, 18 months, and 24 months following application.

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Other: Control group

Endocrown Group

EXPERIMENTAL

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

Other: Endocrown group

Interventions

Control group OTHER

ProTaper Next rotary system and iRoot SP sealer with composite restorations.

Control Group

Endocrown group OTHER

ProTaper Next rotary system and iRoot SP sealer with endocrown restorations.

Endocrown Group

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, Egypt

Location

MeSH Terms

Conditions

Tooth, Nonvital

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Roqaia M Alassar, DDS

  Fixed Prosthodontist, Faculty of Dental Medicine for Girls, Al-Azhar University

  PRINCIPAL INVESTIGATOR

• Heba Abdelkafy, DDS

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

  PRINCIPAL INVESTIGATOR

• Eman Abdelraouf, DDS

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Control group: the patient will receive direct composite resin restorations. Endocrown group: the patient will receive endocrown restorations.

Study Record Dates

• First Submitted: August 8, 2020
• First Posted: August 13, 2020
• Study Start: October 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2021
• Last Updated: December 28, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)