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Completed

NCT Number: NCT04511117

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

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.

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Key information

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control Group

Other

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

Endocrown group

Other

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

Primary outcomes

  1. Change in marginal adaptation, discoloration and surface of the restoration.

    Time frame: At 6 months, 12 months, 18 months, and 24 months following application.

    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 outcomes

  1. Change in the Retention Status.

    Time frame: At 6 months, 12 months, 18 months, and 24 months following application.

    Debonding or dislodgement of the restoration.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Aug 13, 2020
Registry last updated
Dec 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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