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

Mahidol University

Status: Completed

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

Treatments: Other: Pain questionnaire; Other: Modified Dental Anxiety Score (MDAS) questionnaire; Other: Oral Health-Related Quality of Life (OHRQoL) questionnaire

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04950491

DT 071/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Test group (s-CAIS)

Experimental group

Description:

The test group workflow used a fully computer-guided implant surgical protocol.

Treatment:

Other: Modified Dental Anxiety Score (MDAS) questionnaire

Other: Oral Health-Related Quality of Life (OHRQoL) questionnaire

Other: Pain questionnaire

Control group (CIS)

Other group

Description:

The control group workflow used a conventional implant surgical protocol.

Treatment:

Other: Modified Dental Anxiety Score (MDAS) questionnaire

Other: Oral Health-Related Quality of Life (OHRQoL) questionnaire

Other: Pain questionnaire