Passivity of Full-Arch Co-Cr Maxillary Prostheses Using IOS

Ain Shams University

Status: Completed

Conditions: Passivity of Co-Cr Full-arch Maxillary Prostheses Via IOS

Treatments: Other: Auxiliary Geometric Device (PS); Other: Open tray impression technique; Other: Auxiliary Geometric Device (M600)

Study type: Interventional

Funder types: Other

Identifiers

NCT07370701

FDASU-RecID022318

Details and patient eligibility

About

Statement of the problem: Accurate digital scans of edentulous patients is challenging due to the absence of anatomic landmarks and geometric variations along the dental arch. Whether adding an auxiliary geometric device (AGD) will improve scanning is unclear.

Purpose: The aim of the study is to analyze the accuracy of complete-arch digital scans of completely edentulous arches by placing auxiliary geometric device.

Material and Methods: This in vivo study included patients who received complete arch screw-retained prostheses supported by 4 implants. Seven patients were randomly chosen; a dual scan protocol was performed for digital implant planning. Surgical guide and AGD were 3d printed. Three different data acquisition methods for each individual: Open tray impression digitized by extraoral scanner (EO Group), Intraoral scan by using Medit i600 with AGD (M600 Group), and Intraoral scan (CEREC Primescan; Dentsply Sirona) with AGD (PS Group). A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants.

Enrollment: 7 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• For a maxillary edentulous patient, the last extraction should be at least six months
• Non-smokers
• 50-70 years of age
• Have good oral hygiene and motivation.

Exclusion criteria

• Patients with major systemic diseases that may affect osseointegration
• Uncontrolled diabetes mellitus
• The need for extensive bone grafting in the planned implant site
• Pregnant female patient
• Under bisphosphonate treatment
• Limited mouth-opening for executing the guided implant surgery.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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7 participants in 3 patient groups

Open tray impression digitized by extraoral scanner (EO Group)

Experimental group

Description:

A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants.

Treatment:

Other: Open tray impression technique

Intraoral scan by using Medit i600 with AGD (M600 Group)

Experimental group

Description:

A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants.

Treatment:

Other: Auxiliary Geometric Device (M600)

Intraoral scan (CEREC Primescan; Dentsply Sirona) with AGD (PS Group)

Experimental group

Description:

A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants.

Treatment:

Other: Auxiliary Geometric Device (PS)