NCT05709236

Brief Summary

28 participants with edentulous maxillary arches were randomly selected and enrolled in two equal groups; Group I conventional impression group (CIG) and Group II Digital impression group (DIG). All patients were rehabilitated with maxillary screw-retained implant prosthesis retained by 6 implants. Prosthodontic complications and peri-implant MBL were registered at 6,12, and 24 months (m). Data was collected and statistically analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

2.3 years

First QC Date

January 16, 2023

Last Update Submit

January 31, 2023

Conditions

Jaw, Edentulous

Keywords

edentulousimplantScrew retainedDigital impression

Outcome Measures

Primary Outcomes (1)

  • Number of events of prosthodontic complications

    For both groups, the prosthodontic complications of the maxillary screw-retained implant prosthesis were monitored and calculated during the twenty four months follow up period according to the following events: Loss of the cover of access hole, Framework fracture, Fractured acrylic resin, Prosthetic teeth fracture, Screw loosening of the abutment, Screw fracture of the abutment, Screw loosening of the prosthesis, Screw fracture of the prosthesis.

    - 6 months, 12 months and 24 months

Secondary Outcomes (1)

  • Amount of marginal bone loss

    6 months, 12 months and 24 months

Study Arms (2)

Completely edentulous maxillary arch digital impression

EXPERIMENTAL

treated with Maxillary screw-retained prosthesis with digital full-arch impression

Device: Maxillary screw-retained prosthesis

Completely edentulous maxillary arch conventional impression

ACTIVE COMPARATOR

treated with Maxillary screw-retained prosthesis with conventional full-arch impression

Device: Maxillary screw-retained prosthesis

Interventions

Maxillary screw-retained prosthesisDEVICE

Maxillary screw-retained prosthesis with conventional full-arch impression with conventional or digital impression

Completely edentulous maxillary arch conventional impressionCompletely edentulous maxillary arch digital impression

Eligibility Criteria

Age56 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with maxillary edentulous ridges opposing fully dentulous mandibular arch or with a minimum of six anterior teeth (canine to canine), and the utmost one or two premolar/molar missing in any quadrant
  • patients with compromised facial/lip support seeking a fixed prosthesis for their edentulous maxilla
  • having edentulous maxilla with adequate bone density and height to place six implants as assessed clinically and radiographically, and physically
  • psychologically eligible patients for implants placement.

You may not qualify if:

  • debarred medically compromised patients
  • smokers
  • patients suffering from parafunctional habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delta University for Science & Technology

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Jaw, EdentulousMouth, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth DiseasesTooth Diseases

Study Officials

  • Wafaa Ibrahim, PHD

    Assoc. Prof.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 16, 2023

First Posted

February 2, 2023

Study Start

January 5, 2020

Primary Completion

May 10, 2022

Study Completion

August 10, 2022

Last Updated

February 2, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)