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

Mahidol University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

Modified Dental Anxiety Score (MDAS) questionnaireOTHER

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.

Pain questionnaireOTHER

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.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Dentistry, Mahidol University

Ratchathewi, Bangkok, Thailand

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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