NCT05912725

Brief Summary

The purpose was to evaluate the accuracy of traditional and digital implant level impression procedures by using three-dimensional superimposition analysis , and evaluate the passive fit of screw- retained implant supported restorations fabricated using conventional and digital impression techniques in bilateral distal extension cases (class I kennedy classification)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

1.7 years

First QC Date

June 12, 2023

Last Update Submit

June 20, 2023

Conditions

Partial Edentulism Class 1

Keywords

Digital impressionimplant impressionimpression accuracyDigital work flow

Outcome Measures

Primary Outcomes (1)

  • Accuracy of digital and conventional implant impression techniques in partially edentulous patient

    GOM Inspect 2016, Gom GmbH,) that was used to superimpose the Standard tessellation language (STL) datasets of conventional open tray impression technique onto the STL file of the reference (digital implant impression technique) to assess the accuracy and calculate the three-dimensional deviations of scan bodies in color- coding map in micrometers (µm)

    12 months

Study Arms (1)

Accuracy of Implant impression techniques

EXPERIMENTAL

Active comparative : digital implant impression Participants underwent intra-oral scanning digital impression Experimental : conventional implant impression Participants underwent conventional impressions And right side of pt mouth received screw retained prosthesis constructed from conventional impression left side received screws retained prosthesis constructed from digital impression

Procedure: Implant placement

Interventions

Implant placementPROCEDURE

4 implants were placed , 2 implants in each side of the patient mouth opposite lower second premolar and second molar 4 implants were placed , 2 implants in each side of the patient mouth opposite lower second premolar and second molar

Accuracy of Implant impression techniques

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All participants have sufficient bone length and width for implant insertion.
  • General health of the patients was evaluated by taking a full medical history to ensure that these patients were free from any systemic conditions that would have impaired implant osseointegration
  • Good oral hygiene
  • Sufficient inter-arch spaces
  • The opposing arch was almost dentulous, and any missing teeth were restored using a fixed partial denture.

You may not qualify if:

  • parafunctional habits
  • Heavy smoking
  • Those patients with systemic diseases that may influence soft or hard tissue healing.
  • Patients with a history of radiation therapy in the head and neck region.
  • Patients with a history of radiation therapy in the head and neck region.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wafaa youssif El ashry

Tanta, 3111, Egypt

Location

Related Publications (1)

  • Elashry WY, Elsheikh MM, Elsheikh AM. Evaluation of the accuracy of conventional and digital implant impression techniques in bilateral distal extension cases: a randomized clinical trial. BMC Oral Health. 2024 Jul 5;24(1):764. doi: 10.1186/s12903-024-04495-0.

    PMID: 38970004DERIVED

Study Officials

  • Wafaa Y El ashry, MSc

    Tanta university ,Faculty of Dentistry, Prosthodontics department

    PRINCIPAL INVESTIGATOR

  • Wafaa Y El ashry

    Tanta university, Faculty of Dentistry, Prosthodontics department

    PRINCIPAL INVESTIGATOR

  • Wafaa Y El ashry, MSc

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer at prosthodontic department

Study Record Dates

First Submitted

June 12, 2023

First Posted

June 22, 2023

Study Start

April 30, 2020

Primary Completion

December 28, 2021

Study Completion

December 14, 2022

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)