An interventional study of Modified Dental Anxiety Score (MDAS) questionnaire and Pain questionnaire in Dental Implantation, Postoperative Pain and Computer-assisted Surgery, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 25 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-06.
Sponsored by Mahidol University · Not applicable, Interventional, and Other
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.
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.
Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.
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The test group workflow used a fully computer-guided implant surgical protocol.
Other: Modified Dental Anxiety Score (MDAS) questionnaire · Other: Pain questionnaire · Other: Oral Health-Related Quality of Life (OHRQoL) questionnaire
The control group workflow used a conventional implant surgical protocol.
Other: Modified Dental Anxiety Score (MDAS) questionnaire · Other: Pain questionnaire · Other: Oral Health-Related Quality of Life (OHRQoL) 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.
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.
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.
Change of post-operative pain for 7 days: Visual Analog Scale
Patients were asked to describe the worst post-operative pain feeling using a standard 10 cm 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.
Change of the proportion of time spent in severe pain for 7 days: 5-category Likert scale
Patients were asked to describe the proportion of time spent in severe pain using 5-category Likert scale (None, Low, Moderate, High, Very high).
Time frame: 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
Patients were asked to describe the number of analgesics taken per day.
Time frame: 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
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).
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 Modified Dental Anxiety Score (MDAS)
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.
Time frame: 1 day (Patients completed the modified MDAS once, while waiting for the surgery in the waiting room.)
Plan to share: No
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Mahidol University