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Patient-reported Outcome Measures Comparing Static Computer-aided Implant Surgery and Conventional Implant Surgery

NCT04950491 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-07-06

No results posted yet for this study

Summary

The aim of this randomized controlled trial was to compare PROMs in patients receiving single tooth replacement in posterior sites by s-CAIS and CIS.

Conditions

  • Dental Implantation
  • Postoperative Pain
  • Computer-assisted Surgery
  • Patient Outcome Assessment
  • Dental Anxiety
  • Quality of Life
  • Oral Health

Interventions

OTHER

Modified Dental Anxiety Score (MDAS) questionnaire

MDAS was used to measure the patients' anxiety toward dental treatment before implant surgery (Humphris, Dyer, \&Robinson, 2009). Originally, the MDAS questionnaire included five questions answered with a 5-category Likert scale. The original MDAS questionnaire does not cover anxiety toward implant surgery. Therefore, a question enquiring about patients' feelings towards implant surgery was added.

OTHER

Pain questionnaire

Patients were asked to describe the worst pain feeling using a standard 10 cm Visual Analog Scale (VAS) and the proportion of time spent in severe pain using a 5 category Likert scale. The number of analgesics taken per day was also asked.

OTHER

Oral Health-Related Quality of Life (OHRQoL) questionnaire

The OHRQoL comprises 14 questions covering problems the patient may in three main categories: oral function, daily activity, and post-operative symptoms (Chaushu, Becker, Zeltser, Vasker, \& Chaushu, 2004). Patients answered using a 5-category Likert scale.

Sponsors & Collaborators

  • ITI Foundation

    collaborator INDUSTRY

  • Mahidol University

    lead OTHER

Principal Investigators

  • Chatchai Kunavisarut, DDS · Department of Advanced General Dentistry, Faculty of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-09
Primary Completion
2020-11-27
Completion
2021-03-11

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04950491 on ClinicalTrials.gov