NCT04950491

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

Patient-reported Outcome Measures (PROMs) Comparing Static Computer-aided Implant Surgery (s-CAIS) and Conventional Implant Surgery (CIS) for Single-tooth Replacement: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

Since current patient-reported outcome measures (PROMs) evidence related to static computer-aided implant surgery (s-CAIS) compared with conventional implant surgery (CIS), particularly in partial edentulous patients, were still limited. 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

Type	Name	Description
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.

Timeline

• Start date: 2019-07-09
• Primary completion: 2020-11-27
• Completion: 2021-03-11
• First posted: 2021-07-06
• Last updated: 2021-07-06

Locations

1 site across 1 country: Thailand