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

Sponsor
Melek ÇAM (Other)
Overall Status
Completed
CT.gov ID
NCT04409028
Collaborator
Okan University (Other)
68
1
2
12.7
5.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Coronal restoration
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Effect of Coronal Restoration Type of Endodontic Treated Posterior Teeth on Quality of Life and Satisfaction Patients.
Actual Study Start Date :
Dec 20, 2018
Actual Primary Completion Date :
Dec 20, 2019
Actual Study Completion Date :
Jan 10, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Quality life of patients [one year]

    the scores given by participants to OHIP-14 survey

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Okan University İstanbul Tuzla Turkey 34947

Sponsors and Collaborators

  • Melek ÇAM
  • Okan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Melek ÇAM, Assist. Prof., Okan University
ClinicalTrials.gov Identifier:
NCT04409028
Other Study ID Numbers:
  • 12122018/100
First Posted:
Jun 1, 2020
Last Update Posted:
Jun 1, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Melek ÇAM, Assist. Prof., Okan University

Study Results

No Results Posted as of Jun 1, 2020