Assessment of Marginal and Internal Fit of High Performance Polymer PEEK Endocrown Using Two Preparation Designs

Official title

Assessment of Marginal and Internal Fit of High Performance Polymer Endocrown Using Two Preparation Designs (Randomized Clinical Trial)

Overview

First, Participants in this study will be recruited according to inclusion criteria. Proper examination for the participants (clinically and radiographically). Preparation for endodontically treated molar for receiving high performance polymer endocrown. Checking and verification for the restoration (trying) and assessment of marginal and internal fit by replica technique. Then final cementation of endocrown.

Detailed description

Examination and diagnosis:

Selection and examination of the patients according to inclusion and exclusion criteria. Diagnosis of the patient's chief complaint and teeth that will be involved in this study will be done.

Primary alginate impressions for diagnosis on primary casts and for mounting. The patients will be asked to maintain good oral hygiene measures by using tooth brush twice daily.

Taking a professional pre-operative photo.

Tooth preparation procedure:

Preparation of endocrown with two preparation designs on endodontically treated molars.

After tooth preparation, the final impression will be taken for each participant using polyvinyl siloxane impression and temporization of cavity using light curable temporary material.

Restoration trial appointment:

Endocrown try in and assessment of marginal and internal fit using replica technique with light body rubber impression.

Fabrication of final restoration:

Delivery of high performance polymer endocrown will be fabricated according to the two preparation designs; butt and bevel.

Interventions

• Other Bevel marginal design endocrown for endodontically treated teeth
  Bevel marginal design will be prepared for endodontically treated teeth and restores with Peek endocrown
• Other Butt marginal design endocrown for endodontically treated teeth
  Butt marginal design will be prepared for endodontically treated teeth and restores with Peek endocrown

Primary outcome measures

• Marginal fit [Time frame: 2 weeks]

Secondary outcome measures (1)

• Internal fit [Time frame: 2 weeks]

Eligibility criteria

Inclusion criteria

• Patient age range from 18 years -50 years old. They should be able to read and write so they can sign the informed consent.
• Patient should have a good physical and psychologically state to be able to withstand the steps of the restoration procedure.
• Have a molar with root canal filling with no active periodontal or apical involvement.
• Patients having root canal treatment teeth indicated for endocrown treatment with 3 or 4 axial walls remaining.
• Patient with axial wall length not less than 3 mm and not more than 5 mm.
• Patient should have good oral hygiene and motivation.

Exclusion criteria

• Patient with periodontal or apical involvement or improper root canal treatment.
• Severe loss of the tooth structure in which the amount of the remaining tooth structure is less than 2mm.
• Patient with poor oral hygiene or with occlusal instability
• Patient with improper physical or psychological state.
• Patient not pregnant or lactating.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

Egypt · 1 center

• Cairo University — Cairo

Identifiers

NCT: NCT06500845 · 3324

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗