NCT05974215

Brief Summary

This study aims to evaluate the effect of mandibular implant supported removable overdenture on bone height and density and compare it with implant supported fixed overdenture in single mandibular overdenture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 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 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

July 26, 2023

Last Update Submit

August 6, 2023

Conditions

Implant Site Reaction

Keywords

Bone heightBone densityImplant supported

Outcome Measures

Primary Outcomes (2)

  • assessment of change of bone height around dental implants

    bone height was assessed by cone beam computed tomography

    on the first day, on 30th day, 90th day

  • assessment of change of bone density around dental implants

    bone density was assessed by cone beam computed tomography

    on the first day, on 30th day, 90th day

Study Arms (2)

group 1

ACTIVE COMPARATOR

patients received mandibular implant supported removable overdenture

Device: assessment of change in bone height by cone beam computed tomography

group 2

ACTIVE COMPARATOR

patients received mandibular implant supported fixed overdenture

Device: assessment of change in bone height by cone beam computed tomography

Interventions

assessment of change in bone height by cone beam computed tomographyDEVICE

bone height was measured at 1 ,30 ,90 days after denture insertion

group 1group 2

Eligibility Criteria

Age40 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Non-smoker Patients
  • Highly cooperative and motivated patients.
  • Patients Systemically free from any immunosuppressive diseases.

You may not qualify if:

  • Diabetic, hypertensive, cancer patients.
  • Mandibular arch with thin knife edge, flat or flabby ridge, recent extractions and foreign bodies.
  • Patients with temporo-mandibular joint disorders and bad oral habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Research Centre

Cairo, 12622, Egypt

Location

Study Officials

  • Menatallah Elhotieby, Researcher

    National Research Centre, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
each patient was not informed about type of received restoration
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: group 1 mandibular implant supported overdenture group 2 mandibular implant supported fixed overdenture
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
researcher fixed and removable prosthodontics

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 3, 2023

Study Start

April 1, 2023

Primary Completion

July 1, 2023

Study Completion

July 5, 2023

Last Updated

August 8, 2023

Record last verified: 2023-08

Locations

EG(1)