Accuracy of Two Methods of Making Impressions for Complete-arch Implant Supported Fixed Prosthesis

A Randomized Controlled, Double-blind Clinical Trial to Evaluate the Clinical Effectiveness of Two Methods of Taking Impressions for an Implant-supported Fixed Prostheses With One-piece Titanium Frameworks in Edentulous Jaws

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06343441

Enrollment

Registered

2024-04-02

Start date

2024-03-31

Completion date

2024-12-31

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous Jaw

Brief summary

To compare the accuracy of digital impression and conventional impression for complete-arch implant-supported fixed prosthesis

Detailed description

The Intraoral scan is digital optical scan method, that has advantages such as being more comfortable, easy to transfer, and full digital workflow. Conventional impression using silicon rubber and gained stable accuracy of impression. This study aims to compare the accuracy of two methods.

Interventions

DEVICEintraoral scan

intraoral scanning of the edentulous arch and scan body

DEVICEopen tray impression

conventional method of impression making with silicone rubber material

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Age 18-70 years old (including 18 and 70 years old); * The patient's maxilla or mandible cannot be preserved due to missing teeth or remaining teeth proposed for implant-retained restoration; * The patient's missing teeth area is available for placement of 4-6 implants; * Completion of osseointegration of the patient's implants after implant surgery; * The patient has at least 2 mm width of keratinized mucosa in the remaining alveolar ridge; * The patient voluntarily participates in the trial and signs an informed consent form

Exclusion criteria

* The patient has a severe gag reflex; * The patient has an intermaxillary distance of less than 20 mm in the posterior region; * The distance between the two implants is less than 10 mm; * Implants fitted with composite abutments with the abutment screw holes penetrating at an angle greater than 60 degrees to the alveolar ridge; * Other patients judged by the investigator to be unsuitable for inclusion

Design outcomes

Primary

Measure	Time frame	Description
Grade of framework passive fit	during the deliver of the framework	The passive fit of the titanium framework is measured with a scoring system. Five aspects are evaluated. whether to pry; Single Screw Probing misfit; All Screws; Probing misfit; Smooth during screwing; X-ray for misfit. For each aspect, 0/1 is scored. the total score is between 0 and 5.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026