Endocrowns vs.Ceramic Onlays Used in Endodontically Treated Teeth- Randomized Clinical Study

NCT03064516 | Completed

• 1 other identifier: UNIB2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To evaluate the immediate and mediate outcomes of endocrowns and onlay ceramic restorations with glass fiber pin in endodontically treated teeth. Material and methods: A randomized controlled clinical trial, a double-blind (patient and examiner) is conducted by one trained and calibrated operators who perform all restorative procedures. The restorations are evaluated longitudinally by a blind and calibrated examiner using the USPHS. A total of 20 patients will be randomly assigned to each group for a total of 40 patients. The randomization sequence will be generated (www.sealedenvelope.com) and to ensure the confidentiality of the allocation, this will be used opaque, sealed and numbered envelopes in series. These will be kept with an independent researcher for the moment of inclusion of the subjects. In the group of onlays, the teeth receive a fiberglass pin in the main root canal and composite resin filling. In the group of endocrown, only the restoration fill the pulp chamber. The parts are milled in IPS e-max CAD (Ivoclar Vivadent) and cemented with the Multilink cementation system (Ivoclar Vivadent). The immediate clinical (focused in restoration and patient) and mediate (radiographic and clinical) outcomes will be compared between the groups. Survival and success rates will be defined in 24 months. Survival will be established by Kaplan-Meier survival curve and log-rank can be conducted to identify as variables associated with as failures over time. Multivariate analysis with the Cox regression models will be condutcted for the determination of failure predictors. For all analyzes, the significance value will be adjusted to 5%.

Conditions

Ceramic Restorations in Endodontically Treated Teeth

Outcome Measures

Primary Outcomes (1)

• Survival of restorations

  To evaluate the survival of different restorative treatments.

  Up to 24 months

Secondary Outcomes (3)

• Scale to discomfort

  Immediately to restoration procedure

• Cost-efficacy analysis by total value of treatment in relation to efficacy

  Up to 24 months

• Questionnaire of Oral health quality of life (OHIP)

  Up to 24 months

Study Arms (2)

Endocrown

EXPERIMENTAL

Restorations with ceramic endocrown in endodontically treated teeth

Procedure: Endocrown

Onlay and fiber pin

ACTIVE COMPARATOR

Restorations with onlay ceramic and glass fiber pin in endodontically treated teeth

Procedure: Onlay and fiber pin

Interventions

Endocrown PROCEDURE

In experimental group, the researches will be performed in the Endocrown group- only the ceramic restoration will fill the pulp chambre in teeth treated endodontically. Cusps will be preserved.

Endocrown

Onlay and fiber pin PROCEDURE

In control group, the researches will be performed in the onlay ceramic restorations with glass fiber pin group in endodontically treated teeth- the teeth receive a fiberglass pin in the main root canal and composite resin filling. Cusps will be preserved.

Onlay and fiber pin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of molars or pre molars with endodontic treatment with at least 1 face (buccal or lingual) or 1 cusp with adequate thickness of 3 mm;
• Presence of opposing teeth and normal occlusion;
• Supragingival margin after preparation;
• Volunteers with good oral hygiene (no active caries, gingivitis, periodontal disease or any other disease in the soft or hard tissues of the oral cavity);
• The selected teeth should not present restorations, cracks, hypoplasias or caries lesions in the adjacent remaining faces;
• Not being in orthodontic treatment;
• Be at least 18 years old.

You may not qualify if:

• Patients will be excluded with special needs, using orthodontics devices and / or systemic diseases which may affect the oral cavity;
• Teeth that undergo radiographic or clinical examination with painful symptomatology, unsatisfactory endodontic treatment, mobility, presence of abscess or fistula next to the tooth, teeth with restorations, sealants or enamel formation defects or signs of periapical alteration will also be excluded;
• \) Volunteers smokers and pregnant women; 5) Volunteers without agenda compatible with the research schedule.

Sponsors & Collaborators

• Susana Morimoto: lead

Study Sites (1)

Universidade Ibirapuera

São Paulo, São Paulo, 04661-100, Brazil

Location

MeSH Terms

Interventions

Inlays

Intervention Hierarchy (Ancestors)

Dental Restoration, Permanent; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Two arms: Endocrowns vs partial ceramic restoration with post

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: February 27, 2017
• Study Start: March 20, 2017
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: October 30, 2019

Record last verified: 2019-10

Locations

BR (1)