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

Sponsor

Mahidol University (Other)

Overall Status

Completed

CT.gov ID

NCT04950491

Collaborator

ITI Foundation (Industry)

Enrollment

Location

Arms

20.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Implantation Postoperative Pain Computer-assisted Surgery Patient Outcome Assessment Dental Anxiety Quality of Life Oral Health	Other: Modified Dental Anxiety Score (MDAS) questionnaire Other: Pain questionnaire Other: Oral Health-Related Quality of Life (OHRQoL) questionnaire	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 9, 2019

Actual Primary Completion Date :

Nov 27, 2020

Actual Study Completion Date :

Mar 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test group (s-CAIS) The test group workflow used a fully computer-guided implant surgical protocol.	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.
Other: Control group (CIS) The control group workflow used a conventional implant surgical protocol.	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.

Arm

Intervention/Treatment

Experimental: Test group (s-CAIS)

The test group workflow used a fully computer-guided implant surgical protocol.

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.

Other: Control group (CIS)

The control group workflow used a conventional implant surgical protocol.

Other: Modified Dental Anxiety Score (MDAS) questionnaire

Other: Pain questionnaire

Other: Oral Health-Related Quality of Life (OHRQoL) questionnaire

Outcome Measures

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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