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

Endodontically Treated Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04511117
• Other study ID #: PD-P-019-002
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: November 1, 2021

Study information

• Verified date: December 2021
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. Biomechanical preparation using; 2.6% NaOCl for irrigation, ProTaper Next rotary files for instrumentation and 17% EDTA gel for lubrication.

2. Obturation of root canal using; ProTaper gutta-percha and iRoot SP sealer.

• Second step: Endocrown restoration protocol will be used as the following:

1. Occlusal Butt joint design for Endocrown preparation.

2. Putty-wash technique for taking impression.

3. IPS e.max CAD for Endocrown construction.

4. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endodontically Treated Teeth
• Permanent Molars
• Tooth, Nonvital

Intervention

Other:
• Control group
ProTaper Next rotary system and iRoot SP sealer with composite restorations.
• Endocrown group
ProTaper Next rotary system and iRoot SP sealer with endocrown restorations.

Locations

Country	Name	City	State
Egypt	Faculty of Dental Medicine for Girls, Al-Azhar University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the Retention Status.	Debonding or dislodgement of the restoration.	At 6 months, 12 months, 18 months, and 24 months following application.