NCT04409028

Brief Summary

This study aimed to evaluate the impacts of coronal restorations of endodontic treated posterior teeth (ETPT) on the satisfaction and quality of patient's life. The patients who were chosen for this purpose were asked to fill in 3 questionnaires.Electronic charts and files of patients who received endodontic treatment in our faculty between 2018 and 2020 were reviewed and chosen. The patients included in the study had been treated by the same endodontist and restorative dental specialist. The coronal restoration of the ETPT had to be either direct composite restoration (DCR) or indirect ceramic restoration (ICR). When the data of patient files and database systems were combined, 76 patients were deemed fit for this study. The patients were contacted by phone to request participation in the study. A rendezvous was created for the patients who agreed to get involved in the study, and those who came to the appointment filled in the questionnaires. Demographics, the semantic differential scale, and the OHIP-14 scores provided data that were entered into Minitab 18 software.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 26, 2020

Last Update Submit

May 26, 2020

Conditions

Keywords

OHIP-14Quality of lifeEndodontically treated teethComposite resin

Outcome Measures

Primary Outcomes (1)

  • Quality life of patients

    the scores given by participants to OHIP-14 survey

    one year

Study Arms (2)

indirect restoration

ACTIVE COMPARATOR
Procedure: Coronal restoration

direct restoration

ACTIVE COMPARATOR
Procedure: Coronal restoration

Interventions

A restorative material like composite resin is condensed into the cavity of teeth.

direct restorationindirect restoration

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • (1) patients who received only one nonsurgical, single visit primary root canal therapy to one posterior tooth (premolar/molar) which has no periapical lesion and Class I/II coronal restoration, (2) patient's restoration had occlusal function for a minimum of 1 year, (3) patients who were ≥18 years old and no pregnancy or breastfeeding status (4) patients who had good oral hygiene and full dentition (5) patients who were on the American Society of Anesthesiology I and II.

You may not qualify if:

  • Patients with physical disabilities and communication difficulties, periapical abscess, sinus tract, dental caries were excluded from the study. Patients who had other dental treatments such prosthetic crowns, implants, dental bleaching, filling were not included in the study. Those with open apex teeth were also excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Okan University

Istanbul, Tuzla, 34947, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

May 26, 2020

First Posted

June 1, 2020

Study Start

December 20, 2018

Primary Completion

December 20, 2019

Study Completion

January 10, 2020

Last Updated

June 1, 2020

Record last verified: 2020-05

Locations