Quality of Life Clinical Trial
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
NCT number | NCT04950491 |
Other study ID # | DT 071/2019 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 9, 2019 |
Est. completion date | March 11, 2021 |
Verified date | June 2021 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 11, 2021 |
Est. primary completion date | November 27, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of Dentistry, Mahidol University | Ratchathewi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University | ITI Foundation |
Thailand,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime. | |
Primary | 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). | Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime. | |
Primary | 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. | Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime. | |
Primary | 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). | Patients were instructed to answer the OHRQoL every day for 7 days starting from the day of surgery 1 hour before bedtime. | |
Secondary | 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. | 1 day (Patients completed the modified MDAS once, while waiting for the surgery in the waiting room.) |
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