NCT05321589

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 21, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

12 months

First QC Date

March 21, 2022

Last Update Submit

April 4, 2022

Conditions

Keywords

digital impression, conventional impression

Outcome Measures

Primary Outcomes (1)

  • accuracy of impression technique

    deviation measurements digitally

    immediately after the intervention/procedure

Secondary Outcomes (1)

  • passivity of final restoration

    immediately after the intervention/procedure

Study Arms (2)

technique 1: conventional splinted open tray impression

OTHER

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.

Other: impression techniques for implant used for maxillary screw retained hybrid prosthesis

technique 2: digital intraoral impression technique

OTHER

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)

Other: impression techniques for implant used for maxillary screw retained hybrid prosthesis

Interventions

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

Also known as: digital and conventional impression techniques
technique 1: conventional splinted open tray impressiontechnique 2: digital intraoral impression technique

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completely edentulous maxillary and mandibular ridges
  • Healthy ridge covered by normal oral mucosa and free from any ridge flabbiness.
  • 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.
  • 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.
  • 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.
  • It's been at least a year since the last extraction.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of Dentistry , Mansoura University

Al Mansurah, DK, 35516, Egypt

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: the conventional open tray splinted impression technique and the digital intraoral impression technique were done for each patient
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 21, 2022

First Posted

April 11, 2022

Study Start

March 1, 2021

Primary Completion

February 20, 2022

Study Completion

March 20, 2022

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations