Clinical trial NCT04511117: 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
Overall status: COMPLETED
Phase: NA
Conditions: Endodontically Treated Teeth
Permanent Molars
Keywords: Endocrown,
Monoblock restoration,
Endodontically treated teeth
Young age
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 10
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group: the patient will receive direct composite resin restorations. Endocrown group: the patient will receive endocrown restorations.
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

  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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in marginal adaptation, discoloration and surface of the restoration.
timeFrame: At 6 months, 12 months, 18 months, and 24 months following application.
Secondary outcomes:
measure: Change in the Retention Status.
timeFrame: At 6 months, 12 months, 18 months, and 24 months following application.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine for Girls, Al-Azhar University
Study officials:
affiliation: Fixed Prosthodontist, Faculty of Dental Medicine for Girls, Al-Azhar University
name: Roqaia M Alassar, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Endodontist, Faculty of Dental Medicine for Girls, Al-Azhar University
name: Heba Abdelkafy, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Pedodontist, Faculty of Dental Medicine for Girls, Al-Azhar University
name: Eman Abdelraouf, DDS
role: PRINCIPAL_INVESTIGATOR
References: