Patient-reported Outcome Measures Comparing Static Computer-aided Implant Surgery and Conventional Implant Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Dental Implantation, Postoperative Pain, Computer-assisted Surgery, Patient Outcome Assessment, Dental Anxiety, Quality of Life, Oral Health

Intervention / Treatment
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* Other: Modified Dental Anxiety Score (MDAS) questionnaire
* Other: Pain questionnaire
* Other: Oral Health-Related Quality of Life (OHRQoL) questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group (s-CAIS)<br>The test group workflow used a fully computer-guided implant surgical protocol. | Other: Modified Dental Anxiety Score (MDAS) questionnaire<br>* 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.<br>Other: Pain questionnaire<br>* 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.<br>Other: Oral Health-Related Quality of Life (OHRQoL) questionnaire<br>* 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.<br>|
| Other: Control group (CIS)<br>The control group workflow used a conventional implant surgical protocol. | Other: Modified Dental Anxiety Score (MDAS) questionnaire<br>* 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.<br>Other: Pain questionnaire<br>* 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.<br>Other: Oral Health-Related Quality of Life (OHRQoL) questionnaire<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Anxiety, Clinical Research, Dental Implant, Static Computer-Aided Implant Surgery (s-CAIS), Patient-Reported Outcome Measures (PROMs), Pain, Oral Health-Related Quality of Life (OHRQoL)