Accuracy of Conventional and Digital Impression Techniques Used for Maxillary Hybrid Prosthesis

April 4, 2022 updated by: Gilan Altonbary, Mansoura University

Accuracy of Digital and Conventional Impression Techniques for Maxillary Full Arch Screw Retained Hybrid Prosthesis

evaluation and comparison of the accuracy of conventional and digital impression for full arch screw retained prosthesis for edentulous maxilla.

Study Overview

Detailed Description

Each patient received 6 implants in the maxillary ridge (widely distributed across the arch) in the following positions: central incisors, canines/first premolar teeth and first molar teeth aided by surgical stent. then each patient received 2 types of impression techniques Technique 1 :conventional impression conventional open tray impression technique with splinted transfers using vinylpolysiloxane and Technique2 : Digital impression taken using original scan bodies torqued to the implants .three dimensional accuracy of impression techniques was evaluated using linear measurements and 3D deviation between the two techniques was measured.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • DK
      • Mansoura, DK, Egypt, 35516
        • Faculty of dentistry , Mansoura university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patients were selected according to the following inclusion criteria:

    1. Completely edentulous maxillary and mandibular ridges
    2. Healthy ridge covered by normal oral mucosa and free from any ridge flabbiness.
    3. All of the patients were dissatisfied with the retention and stability of their maxillary conventional dentures and expressed a strong desire for a more stable prosthesis.
    4. Sufficient bone quantity and quality in the front and posterior maxillary regions, as determined by preoperative CBCT, to accommodate six implants with a diameter of at least 3.5 mm and a length of at least 10 mm.
    5. Enough restorative space (from the mucosa covering the crest of the maxillary residual ridge to the occlusal plane) to allow the fixed prosthesis to be constructed ,preliminary jaw relationship revealed this.
    6. It's been at least a year since the last extraction.

      Exclusion Criteria:

    1. Systemic diseases that may alter tissue response to implantation and affects osseointegration (radiation, diabetes, osteoporosis, bleeding disorders or hepatic patients)
    2. Long term immunosuppressive and corticosteroid drug therapy.
    3. Patient with abnormal habits as clenching and bruxism.
    4. Smoking patients.
    5. Patients with problems in TMJ.
    6. Neuromuscular diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: technique 1: conventional splinted open tray impression

a conventional open tray impression technique splinted with ligature wire and duralay resin was done with polyvinyl siloxane impression .

analogues were screwed to the impression copings and casts were poured.

conventional splinted open tray impression technique was done for maxillary implants to fabricate screw retained hybrid prosthesis and digital intra oral impression was done for the same patients after screwing scan bodies to the implants intra orally.

evaluation of accuracy and 3D deviation between the two techniques was done

Other Names:
  • digital and conventional impression techniques
OTHER: technique 2: digital intraoral impression technique

scan bodies were screwed to implants intraorally and digital scanner was used to record digital impression, scanning protocol started from occlusal ,buccal to palatal surfaces.

The resulting scans were then exported in the standard tessellation format (.STL)

conventional splinted open tray impression technique was done for maxillary implants to fabricate screw retained hybrid prosthesis and digital intra oral impression was done for the same patients after screwing scan bodies to the implants intra orally.

evaluation of accuracy and 3D deviation between the two techniques was done

Other Names:
  • digital and conventional impression techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy of impression technique
Time Frame: immediately after the intervention/procedure
deviation measurements digitally
immediately after the intervention/procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
passivity of final restoration
Time Frame: immediately after the intervention/procedure
Clinical measurement of prosthesis passivity using single screw test of Sheffield.
immediately after the intervention/procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2021

Primary Completion (ACTUAL)

February 20, 2022

Study Completion (ACTUAL)

March 20, 2022

Study Registration Dates

First Submitted

March 21, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (ACTUAL)

April 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • A25100221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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