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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mahidol University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change of the analgesics taken per day for 7 days: the number of tablets per day
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 80 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Test group (s-CAIS)
The test group workflow used a fully computer-guided implant surgical protocol.
Intervention: Modified Dental Anxiety Score (MDAS) questionnaire (Other)
Test group (s-CAIS)
The test group workflow used a fully computer-guided implant surgical protocol.
Intervention: Pain questionnaire (Other)
Test group (s-CAIS)
The test group workflow used a fully computer-guided implant surgical protocol.
Intervention: Oral Health-Related Quality of Life (OHRQoL) questionnaire (Other)
Control group (CIS)
The control group workflow used a conventional implant surgical protocol.
Intervention: Pain questionnaire (Other)
Control group (CIS)
The control group workflow used a conventional implant surgical protocol.
Intervention: Modified Dental Anxiety Score (MDAS) questionnaire (Other)
Control group (CIS)
The control group workflow used a conventional implant surgical protocol.
Intervention: Oral Health-Related Quality of Life (OHRQoL) questionnaire (Other)
Outcomes
Primary Outcomes
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.
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).
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.
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).
Secondary Outcomes
- The Modified Dental Anxiety Score (MDAS)(1 day (Patients completed the modified MDAS once, while waiting for the surgery in the waiting room.))
Investigators
Akarin Santivitoonvong
Doctor of Dental Surgery
Mahidol University