NCT06114966

Brief Summary

This study is aimed to compare between titanium framework and soft metal framework used for mandibular All-on-4 implant supported prosthesis. The evaluation will be for:

  • Peri-implant soft tissue health including; Plaque index, Probing depth and bleeding index.
  • Bone level changes around implant using periapical x-ray after 6 months and 12 months and 18 months from insertion of fixed prosthesis.
  • Framework adaptation of titanium framework and soft metal framework using surface matching software. Patient grouping:
  • 20 Patients will be classified into 2 equal groups, first group will receive 4 implants placed according to All on 4 concept supporting screw retained prosthesis with titanium framework manufactured by dry milling technique, second group will receive 4 implants placed according to All on 4 concept supporting screw retained prosthesis with metal framework manufactured by dry milling/post sintering of Co-Cr soft metal blocks. The evaluation will be for:
  • Bone level changes around implant using periapical x-ray after 6 months and 12 months and 18 months from insertion of fixed prosthesis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

September 20, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

1.6 years

First QC Date

October 23, 2023

Last Update Submit

October 30, 2023

Conditions

Dental Prosthesis

Outcome Measures

Primary Outcomes (1)

  • Peri-implant crestal bone resorption

    Crestal bone level will be evaluated by Periapical x-ray

    at time of insertion of prosthesis procedure T(0), 6 months after insertion T(6), 12 months after insertion T(12), 18 months after insertion (T18)

Study Arms (2)

titanium framework manufactured by dry milling technique

EXPERIMENTAL

All patients will have titanium framework manufactured by dry milling technique and occlusal material made from PMMA FPD

Other: CADCAM

metal framework manufactured by dry milling/post sintering of Co-Cr soft metal blocks

EXPERIMENTAL

All patients will have metal framework manufactured by dry milling/post sintering of Co-Cr soft metal blocks and occlusal material made from PMMA FPD

Other: CADCAM

Interventions

CADCAMOTHER

Milling of Final prosthesis over dental implants using CADCAM milling machine

metal framework manufactured by dry milling/post sintering of Co-Cr soft metal blockstitanium framework manufactured by dry milling technique

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Completely edentulous maxillary and mandibular ridges with sufficient mandibular bone height in the inter-foraminal area confirmed with panoramic x-rays.
  • All selected patients will be with sufficient inter-arch space and restorative space.
  • All selected patients will have apparently healthy ridge covered by compressible oral mucosa and free from any ridge flabbiness.

You may not qualify if:

  • Patients with systemic diseases that contraindicate implant placement such as hematologic diseases, serious problems of coagulation and diseases of the immune system. Also, metabolic diseases related to bone resorption such as uncontrolled diabetics or osteoporosis will be also excluded
  • History of para-functional habits (Bruxism, clenching), smoking and alcoholism.
  • History of radiation therapy in the head and neck region.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University, Faculty of dentistry

Al Mansurah, Egypt

RECRUITING

Study Officials

  • Mohamed Shady, MD

    Mansoura University Faculty of Dentistry, Prosthodontics department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Shady, MD

CONTACT

01005225707Mohamedshady@mans.edu.eg

Study Design

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

Study Record Dates

First Submitted

October 23, 2023

First Posted

November 2, 2023

Study Start

September 20, 2023

Primary Completion

April 20, 2025

Study Completion

May 20, 2025

Last Updated

November 2, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)