Clinical trial NCT04950491: Patient-reported Outcome Measures Comparing Static Computer-aided Implant Surgery and Conventional Implant Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implantation
Postoperative Pain
Computer-assisted Surgery
Patient Outcome Assessment
Dental Anxiety
Quality of Life
Oral Health
Keywords: Clinical Research
Dental Implant
Static Computer-Aided Implant Surgery (s-CAIS)
Patient-Reported Outcome Measures (PROMs)
Dental Anxiety
Pain
Oral Health-Related Quality of Life (OHRQoL)
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: ITI Foundation
First posted: 2021-07-06
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of post-operative pain for 7 days: Visual Analog Scale
timeFrame: Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.
measure: Change of the proportion of time spent in severe pain for 7 days: 5-category Likert scale
timeFrame: Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.
measure: Change of the analgesics taken per day for 7 days: the number of tablets per day
timeFrame: Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.
measure: Change of Oral Health-Related Quality of Life (OHRQoL) for 7 days: 5-category Likert scale
timeFrame: Patients were instructed to answer the OHRQoL every day for 7 days starting from the day of surgery 1 hour before bedtime.
Secondary outcomes:
measure: The Modified Dental Anxiety Score (MDAS)
timeFrame: 1 day (Patients completed the modified MDAS once, while waiting for the surgery in the waiting room.)
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Faculty of Dentistry, Mahidol University
state: Bangkok
Study officials:
affiliation: Department of Advanced General Dentistry, Faculty of Dentistry
name: Chatchai Kunavisarut, DDS
role: STUDY_CHAIR
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