The Effect of Coronal Restoration Type on Satisfaction Patients. (OHIP-14)

The Effect of Coronal Restoration Type of Endodontic Treated Posterior Teeth on Quality of Life and Satisfaction Patients.

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life
• Intervention / Treatment: Procedure: Coronal restoration

Detailed Description

This cross-sectional clinical study was approved by the Ethics Committee of the Istanbul Okan University and conducted both at its Endodontics and Restorative Departments of Dentistry Faculty. A query of the Nucleus database (a patient management software) was performed to identify dental charts of patients who received endodontic treatment between December 2018 and January 2020. We searched only for primary endodontic treatment of vital tooth codes, and then selected the same endodontic specialists' patients. A total of 400 teeth were identified for screening. Next, a specified restorative dentistry specialist's patient searched within these patients, and 150 patients were obtained. The study was completed with 68 participants (n=34 each). Then data and radiographs of patients were checked out for the eligibility criteria.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Tuzla
    • İstanbul, Tuzla, Turkey, 34947
      • Okan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: indirect restoration	Procedure: Coronal restoration; A restorative material like composite resin is condensed into the cavity of teeth.
ACTIVE_COMPARATOR: direct restoration	Procedure: Coronal restoration; A restorative material like composite resin is condensed into the cavity of teeth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality life of patients	the scores given by participants to OHIP-14 survey	one year

Collaborators and Investigators

• Sponsor: Melek ÇAM
• Collaborators: Okan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 20, 2018
• Primary Completion (ACTUAL): December 20, 2019
• Study Completion (ACTUAL): January 10, 2020

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (ACTUAL): June 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Quality of life; Composite resin; Endodontically treated teeth; OHIP-14
• Other Study ID Numbers: 12122018/100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No