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

Not Applicable

Completed

• Conditions: Computer-assisted Surgery; Patient Outcome Assessment; Oral Health; Dental Implantation; Postoperative Pain; Dental Anxiety; Quality of Life
• Interventions: Other: Modified Dental Anxiety Score (MDAS) questionnaire; Other: Pain questionnaire; Other: Oral Health-Related Quality of Life (OHRQoL) questionnaire

• Registration Number: NCT04950491
• Lead Sponsor: Mahidol University

Brief 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.

Study Timeline

• Study Start: 2019-07-09
• Primary Completion: 2020-11-27
• Study Completion: 2021-03-11
• Status Verified: 2021-06
• Study First Submitted: 2021-06-23
• Study First Submitted QC: 2021-06-29
• Last Update Submitted: 2021-06-29
• Study First Posted: 2021-07-06
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Healthy or well-controlled systemic disease (ASA classification I,II)
• A partially edentulous ridge in the premolar-molar region with existing two-sided interproximal as well as antagonist contacts
• No sign of acute oral infection
• Periodontally healthy (or successfully treated)
• More than 2 mm of keratinized gingiva at the site of surgery
• Sufficient bony ridge for implant placement with or without simultaneous bone grafting

Exclusion Criteria

• Diabetes mellitus
• Smoking more than ten cigarettes per day
• Pregnancy
• Psychiatric disorder
• History of radiation therapy at head and neck area and chemotherapy
• Bony pathologies, namely osseous dysplasia, odontogenic cyst, tumor
• History of soft tissue grafting at the prospective implant site
• Inadequate bony ridge with the need of bone augmentation prior to implant placement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (CIS)	Pain questionnaire	The control group workflow used a conventional implant surgical protocol.
Test group (s-CAIS)	Modified Dental Anxiety Score (MDAS) questionnaire	The test group workflow used a fully computer-guided implant surgical protocol.
Control group (CIS)	Modified Dental Anxiety Score (MDAS) questionnaire	The control group workflow used a conventional implant surgical protocol.
Test group (s-CAIS)	Pain questionnaire	The test group workflow used a fully computer-guided implant surgical protocol.
Test group (s-CAIS)	Oral Health-Related Quality of Life (OHRQoL) questionnaire	The test group workflow used a fully computer-guided implant surgical protocol.
Control group (CIS)	Oral Health-Related Quality of Life (OHRQoL) questionnaire	The control group workflow used a conventional implant surgical protocol.

Primary Outcome Measures

Name	Time	Method
Change of the analgesics taken per day for 7 days: the number of tablets per day	Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.	Patients were asked to describe the number of analgesics taken per day.
Change of Oral Health-Related Quality of Life (OHRQoL) for 7 days: 5-category Likert scale	Patients were instructed to answer the OHRQoL every day for 7 days starting from the day of surgery 1 hour before bedtime.	The OHRQoL questionnaire comprises 14 questions covering problems the patient may in three main categories: oral function, daily activity, and post-operative symptoms derived from Chaushu's study (Chaushu, Becker, Zeltser, Vasker, \& Chaushu, 2004). Patients answered this questionnaire using a 5-category Likert scale (Not at all, Very little, A little, Quite a lot, Very much).
Change of post-operative pain for 7 days: Visual Analog Scale	Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.	Patients were asked to describe the worst post-operative pain feeling using a standard 10 cm Visual Analog Scale.
Change of the proportion of time spent in severe pain for 7 days: 5-category Likert scale	Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.	Patients were asked to describe the proportion of time spent in severe pain using 5-category Likert scale (None, Low, Moderate, High, Very high).

Secondary Outcome Measures

Name	Time	Method
The Modified Dental Anxiety Score (MDAS)	1 day (Patients completed the modified MDAS once, while waiting for the surgery in the waiting room.)	The MDAS was used to measure patient anxiety toward dental treatment (Humphris, Dyer, \& Robinson, 2009). The MDAS consists of five questions answered with a 5-category Likert scale, ranging from 'not anxious' to 'extremely anxious'. The original MDAS questionnaire does not cover anxiety toward implant surgery. Therefore, a question enquiring about patients' feelings towards implant surgery was added.

Trial Locations

Locations (1)

Faculty of Dentistry, Mahidol University; 🇹🇭 Ratchathewi, Bangkok, Thailand