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)
40
1
2
20.1
2

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
  • 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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).

  3. 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.

  4. 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

  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry, Mahidol University Ratchathewi Bangkok Thailand 10400

Sponsors and Collaborators

  • Mahidol University
  • ITI Foundation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Akarin Santivitoonvong, Doctor of Dental Surgery, Mahidol University
ClinicalTrials.gov Identifier:
NCT04950491
Other Study ID Numbers:
  • DT 071/2019
First Posted:
Jul 6, 2021
Last Update Posted:
Jul 6, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Akarin Santivitoonvong, Doctor of Dental Surgery, Mahidol University

Study Results

No Results Posted as of Jul 6, 2021