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Clinical and Radiographic Evaluation of Resin Endocrown as Long Term Interim Restoration Versus Stainless Steel Crown for Endodontically Treated First Permanent Molar in Children: Randomized Controlled Pilot Study.

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Dental Caries in Children

Treatments

Other: Endocrown "composite".

Study type

Interventional

Funder types

Other

Identifiers

NCT05250609
14422021510951

Details and patient eligibility

About

management of endodontically treated first permanent molar with deep dental caries is one of the challenging procedure that the operator face. Using resin endocrown or stainless steel crown restoration to make comparison which one is more successful in children.

Full description

Diagnostic procedure:

Diagnosis of the cases will be performed according to guidelines of AAPD 2017 for treatment of irreversible pulpitis and necrotic pulp therapy in mandibular first permanent molar . Preoperative periapical radiograph will be taken

Intra operative procedure:

Local anaesthesia administration using articaine 4% with epinephrine 1:100000. Rubber dam application and access cavity preparation will be established using a sterile bur. Root Canal Treatment will be done and then the dental orifices of the pulp chamber will be sealed using a flowable composite.

The immediate postoperative radiograph will be done to reveal optimal root canal treatment.

In the intervention group:

The preparation of cavity design will be as following:

Preparation of occlusal surface will be done with wheel stone to create 2 mm occlusal clearance; the occlusal surface will be prepared flat to create a butt-joint. The junction between the occlusal and mesial cavity will be rounded to produce cervical side walk. • Divergence of the inner cavity walls will be obtained using a tapered stone with a rounded end (TR- Dia Bur Mani).

Impression will be taken for the prepared tooth structure using addition silicone material (Elite HD Zermach, Italy), stone model will be poured for fabrication of endocrown to allow for blockage of any undercuts in the pulp chamber cavity. Finished final endocrown restoration will be cemented in place using self-adhesive universal dual cured resin cement (rely X Unicem, 3M, USA).

In the control group tooth preparation will be made as follow:

By reducing mesial, distal and occlusal surface. The crown margin will be placed just apically to the gingival margin and carefully adjusted to give an accurate fit in this region. The crown will be cemented with glass ionomer cement.

Follow up:

Clinical and evaluation will be performed at 1 st week, 3, 6, 9 and 12 months. Radiograph evaluation will be performed at, 1 st week, 6 and 12 months

Enrollment

24 patients

Sex

All

Ages

10 to 13 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Cooperative children in age range from 10 to 13 years

    • Mandibular first permanent molar indicated for root canal treatment with closed apex.
    • Presence of at least two to three sound walls of tooth.
    • Absence of internal or external pathologic root resorption.
    • Normal occlusion without any para-functional habits.
    • Parent or guardian agree for participant in the study

Exclusion criteria

  • Excessive mobility.
  • Children with underlying systemic disease.
  • Children with special health care needs.
  • Poor oral hygiene.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 2 patient groups

Intervention: Endocrown "composite".
Experimental group
Description:
Composite Endocrown will be used as an extra-coronal restoration in endodontically treated mutilated first permanent molar
Treatment:
Other: Endocrown "composite".
Comparator / Control: Stainless steel crown.
No Intervention group
Description:
Stainless steel crown will be used as an extra-coronal restoration in endodontically treated mutilated first permanent molar

Trial contacts and locations

1

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Central trial contact

Basheer Mabkhot, Ph.D

Data sourced from clinicaltrials.gov

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