NCT06151314

Brief Summary

The increased benefits to the edentulous population from implant supported overdenture is overwhelming in terms of better quality of life, emotional stability, improved function, enhanced esthetics and clinical comfort.1-6 Implant supported prosthesis is considered a viable option for partially edentulous patients7. The oral rehabilitation of a long anterior mandibular edentulous span with a fixed or removable implant-supported prosthesis using appropriate prostheses have been a target in oral implant research for the last year. The longevity of any implant prosthesis depends on successful osseointegration and implant stability. Cone beam computed tomography (CBCT ) has also been used extensively for the follow-up of dental implants and is considered one of the tools for assessing implant success

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

2 active sites

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

December 1, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2023

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

November 21, 2023

Last Update Submit

December 17, 2023

Conditions

Keywords

digital milled partial overdentureBone densityFixed bridge

Outcome Measures

Primary Outcomes (1)

  • assessment of change of bone density around dental implants

    bone density was assessed by cone beam computed tomography

    on the first day,on 1 month ,3months

Secondary Outcomes (1)

  • assessment of change of bone height around dental implants

    on the first day,on 1 month ,3months

Study Arms (2)

"digital milled implant supported removable partial overdenture

ACTIVE COMPARATOR

patients received digital milled implant supported removable partial overdenture.

Procedure: Dental implants.

"implant supported fixed bridge"

ACTIVE COMPARATOR

patients received an implant supported fixed bridge

Procedure: Dental implants.

Interventions

5 conventional implants measuring from 4 to 5 mm in width and 7 to 10mm in length according to the bone width were inserted in the mandible from right premolar area to left premolar area

Also known as: OXY implants
"digital milled implant supported removable partial overdenture"implant supported fixed bridge"

Eligibility Criteria

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

You may qualify if:

  • non smokers
  • Patients having long anterior mandibular edentulous span.
  • Highly cooperative and motivated patients.
  • Patients Systemically free from any immunosuppressive diseases.
  • Patients free from Diabetes, Hypertension, Cancer, any mental or physical diseases.
  • Patients not receiving any Radiotherapy or chemotherapy treatment.

You may not qualify if:

  • Mandibular arch with thin knife edge, flat or flabby ridge, recent extractions, and foreign bodies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Research Centre

Cairo, 12622, Egypt

Location

M

Giza, +20, Egypt

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Menatallah M. Elhotieby, Researcher

    National Research Centre, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 21, 2023

First Posted

November 30, 2023

Study Start

December 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 5, 2023

Last Updated

December 21, 2023

Record last verified: 2023-12

Locations