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

June 29, 2021 updated by: Akarin Santivitoonvong, Mahidol University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Faculty of Dentistry, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of post-operative pain for 7 days: Visual Analog Scale
Time Frame: 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.
Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.
Change of the proportion of time spent in severe pain for 7 days: 5-category Likert scale
Time Frame: 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).
Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.
Change of the analgesics taken per day for 7 days: the number of tablets per day
Time Frame: 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.
Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.
Change of Oral Health-Related Quality of Life (OHRQoL) for 7 days: 5-category Likert scale
Time Frame: 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).
Patients were instructed to answer the OHRQoL every day for 7 days starting from the day of surgery 1 hour before bedtime.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Modified Dental Anxiety Score (MDAS)
Time Frame: 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.
1 day (Patients completed the modified MDAS once, while waiting for the surgery in the waiting room.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

ITI Foundation

Investigators

  • Study Chair: Chatchai Kunavisarut, DDS, Department of Advanced General Dentistry, Faculty of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2019

Primary Completion (Actual)

November 27, 2020

Study Completion (Actual)

March 11, 2021

Study Registration Dates

First Submitted

June 23, 2021

First Submitted That Met QC Criteria

June 29, 2021

First Posted (Actual)

July 6, 2021

Study Record Updates

Last Update Posted (Actual)

July 6, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DT 071/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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