NCT04475913

Brief Summary

Fifty six patients were randomly enrolled in the study. Participants were randomly stratified into two control groups and two test groups, from which conventional pick up and digital impressions were made respectively. Patients of group 1 (CIG Axial) and 3 (DIG Axial) received 4 axial implants whereas, group 2 patients (CIG Tilted), and group 4 (DIG Tilted) received two anterior axial implants and two distal tilted implants. All participants received hybrid dentures. Bone loss, implant loss, maintenance of prosthesis were evaluated at 6m,12m, and 24 months follow up period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

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

July 11, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2020

Completed
Last Updated

March 1, 2021

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

July 14, 2020

Last Update Submit

February 24, 2021

Conditions

Edentulous Mouth

Keywords

impressionsanaloguedigitalAll-on-Four

Outcome Measures

Primary Outcomes (1)

  • implant loss

    The implants were considered surviving if they were clinically stable and functioning without any mobility. Failure was defined removal of implants due to loss of integration, pain, implant mobility, paraesthesia, neuropathies or psychological reasons. Calculation of the estimated failure rate was performed by dividing the number of implant failures by the total exposure time of the implant. The total exposure time is the interval of time the implants could be followed for the entire observation time or up to failure of the implants that were lost during the follow-up period.

    24 months

Secondary Outcomes (1)

  • crestal bone loss

    24 months

Other Outcomes (1)

  • maintenance

    24 months

Study Arms (4)

(CIG Axial)

ACTIVE COMPARATOR

received 4 axial implants and conventional impression

Other: DIG Axial

(DIG Axial)

EXPERIMENTAL

received 4 axial implants and digital impression

Other: DIG TiltedOther: CIG Axial

CIG Tilted

ACTIVE COMPARATOR

received two anterior axial implants and two distal tilted implants, and conventional impression

Other: DIG Tilted

(DIG Tilted)

EXPERIMENTAL

received two anterior axial implants and two distal tilted implants, and digital impression

Other: DIG AxialOther: CIG Tilted

Interventions

DIG AxialOTHER

patients received 4 axial implants and digital impression

(CIG Axial)(DIG Tilted)
DIG TiltedOTHER

received two anterior axial implants and two distal tilted implants, and digital impression

(DIG Axial)CIG Tilted
CIG AxialOTHER

patients received 4 axial implants and conventional impression

(DIG Axial)
CIG TiltedOTHER

received two anterior axial implants and two distal tilted implants, and conventional impression

(DIG Tilted)

Eligibility Criteria

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

You may qualify if:

  • completely edentulous patients with age range from 50-65 years.
  • physically and psychologically eligible participants for implants placement.
  • adequate bone to receive 4 interforaminal implants.

You may not qualify if:

  • participants were excluded if
  • medical conditions that precludes implants placement
  • smokers
  • patients suffering from any parafunctional habits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OctoberUMSA

Giza, 12451, Egypt

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Dina Elawady

    Lecturer

    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
SPONSOR

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 17, 2020

Study Start

July 11, 2018

Primary Completion

July 11, 2020

Study Completion

August 20, 2020

Last Updated

March 1, 2021

Record last verified: 2020-07

Locations

EG(1)