Computer-assisted Surgery, Dental Anxiety, Dental Implantation, Oral Health, Patient Outcome Assessment, Postoperative Pain, Quality of Life
Conditions
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)
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.
Interventions
OTHERModified 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.
OTHERPain 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.
OTHEROral 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.
Sponsors
ITI Foundation
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Thailand
Outcome results
None listed