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Status unknownNCT03476304Updated Nov 15, 2018

Endocrown Restorations Longevity Compared With Post Retained Restorations

An interventional study of Endocrown restoration and Post retained composite restoration in Endodontically Treated Teeth, sponsored by Federal University of Pelotas. Status unknown at 2 sites in Brazil. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-15.

Sponsored by Federal University of Pelotas · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Caries disease is still the leading cause of severe tooth decay. Since this can lead to tooth loss, it is important that appropriate treatment is advised to help prevent damage and maintain tooth health. Faced with major coronary destruction, several times it becomes necessary to perform the endodontic treatment, aiming to maintain the element in the buccal cavity for longer. It is known that an excellent restorative treatment with poor endodontic treatment and the inverse has a direct impact on the (in) success of the treatment. In this context, the proper cleaning of the root canals is highlighted, aiming the removal of bacteria and toxins. Acceptable restorations are those that provide adequate reestablishment of anatomy, function, proximal contacts, and occlusal stability. Traditionally, indirect restorations would be indicated in cases of extensive coronary destruction, because it was believed that they would present greater resistance and longevity when compared to direct restorations. However, contemporary dentistry admits that, thanks to adhesive and conservative principles, this difference between direct and indirect procedures in terms of longevity is not significant. The classic restorative procedure in cases of endodontically treated teeth with great loss of coronary structure involves the use of intraradicular retainers, followed by the creation of core and restoration through total crowns. Removal of healthy tissue for the use of posts can weaken the remaining dental structure and increase the risk of root perforations. In this sense, endocrown restorations show superiority when compared to those made with intraradicular retainers. Although the indications are favorable for the use of endocrown restorations, the clinical evidence available on the subject is still scarce. In this double-blind randomized clinical trial, patients who need and meet the inclusion criteria will will be allocated to one of the three restorative groups available, being endocrown restoration in semi-direct composite resin, direct restoration in composite resin retained on the post and ceramic crown retained in the post. Patients will be monitored annually after completion of restorative treatment outcome. In addition to treatment longevity, other secondary outcomes will be evaluated, such as patient satisfaction, impact on quality of life and cost-effectiveness of the proposed treatments.

02

Conditions studied

  • Endodontically Treated Teeth

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03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18 years old or more;
  • healthy volunteers;
  • molars or premolars with endodontic treatment and large coronal destruction;
  • at least 20 teeth;

Exclusion criteria

Exclusion Criteria:

  • abutment of removable partial denture ;
  • tooth with mobility higher than 1;
  • more than 1/2 bone loss height;
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    Semi-direct composite endocrown restorations

    Device: Endocrown restoration

  • Active comparator
    Post retained direct composite restoration

    Device: Post retained composite restoration

  • Active comparator
    Post retained ceramic restoration

    Device: Post retained ceramic restoration

Interventions

  • DeviceEndocrown restoration

    The endodontically treated tooth will be impressed, and an endocrown restoration will be manufactured with resin composite in a cast and cemented with self adhesive cement

  • DevicePost retained composite restoration

    The endodontically treated tooth will receive a fiber post cemented with self adhesive cement and after this, the tooth will be impressed and a semi direct composite restoration will be cemented with self adhesive cement.

  • DevicePost retained ceramic restoration

    The endodontically treated tooth will receive a fiber post cemented with self adhesive cement and after this, the tooth will be impressed and a ceramic restoration will be cemented with self adhesive cement.

05

What researchers measure

Primary outcomes

  1. Survival

    Tooth will be annually followed until failure, but with a minimal follow-up of two years. They will be evaluated with FDI criteria for evaluation of direct and indirect restorations

    Time frame: 2 years

Secondary outcomes

  1. Satisfaction and quality of life improvement

    Questionnaire will be applied

    Time frame: 2 years

  2. Cost-effectiveness

    The calculation of cost-effectiveness after treatment delivery will be performed

    Time frame: 2 years

06

Study locations

1 of 2 sites recruiting
  • Federal University of Pelotas
    Pelotas, Rs 96015-080, Brazil
    Not yet recruiting
  • Federal University of Pelotas
    Pelotas, RS 96015560, Brazil
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03476304
Lead sponsor
Federal University of Pelotas
Responsible party
Maximiliano Sergio Cenci (PhD, Federal University of Pelotas) — Principal investigator
First posted
Mar 26, 2018
Start date
Apr 2, 2018
Primary completion
Apr 30, 2019 (estimated)
Completion
Apr 30, 2020 (estimated)
Last update
Nov 15, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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