NCT07475507

Brief Summary

A fixed all-on-four prosthesis will be constructed for the lower arch for each patient and the marginal bone loss will be evaluated at baseline, 3,6,9 and 12 months.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress78%
Aug 2024Mar 2027

Study Start

First participant enrolled

August 1, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

2.3 years

First QC Date

March 8, 2026

Last Update Submit

March 11, 2026

Conditions

ProsthodonticsImplants, DentalProsthesisBone Loss, Alveolar

Outcome Measures

Primary Outcomes (1)

  • Marginal bone loss

    Marginal bone loss around each dental implant using parallel technique in digital periodical radiographs which will be measured in mm from the crestal bone level at the implant platform.

    12 months at intervals (0,3,6,9and 12 months)

Secondary Outcomes (1)

  • Bone density

    12 months at intervals (0,3,6,9and 12 months)

Study Arms (2)

Titanium framework reinforced all on four prosthesis

OTHER

Active Comparator: Titanium reinforced fixed all-on-four prosthesis

Other: Titanium framework reinforced all on four prosthesis

PEEK framework reinforced all on four prosthesis

OTHER
Other: PEEK framework reinforced all on four prosthesis

Interventions

PEEK framework reinforced all on four prosthesisOTHER

Fabricating a fixed prosthesis for patients with completely edentulous mandibles reinforced with PEEK

PEEK framework reinforced all on four prosthesis
Titanium framework reinforced all on four prosthesisOTHER

Titanium frameworks provided many advantages as their biocompatibility, corrosion resistance, relatively lower weight and high mechanical properties as well as avoiding the casting errors and technique sensitivity

Titanium framework reinforced all on four prosthesis

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Completely edentulous patients requesting a fixed, implant supported restoration.
  • Patients aged from 45 to 60, able to sign an informed consent will be considered eligible for this trial.
  • Implant sites must allow the placement of four implants.
  • Non- heavy Smokers will be included (smoking up to 10 cigarettes/day)
  • In case of post-extraction sites, they must have been healed for at least 3 months before being treated in the study.
  • Patients with no systemic condition that may interfere with implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino-bisphosphonates)

You may not qualify if:

  • Patients with poor oral hygiene and motivation.
  • Female patients taking any medical treatment for management of osteoporosis.
  • Drug abusers.
  • Psychiatric problems or unrealistic expectations.
  • Patients with active infection or inflammation in the planned implant area at the time of implant placement.
  • Immuno-compromised patients (Diabetic with HBA1C \> 7 or patients undergoing chemo or radiotherapy or bisphosphonates)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, 11251, Egypt

Location

Related Publications (1)

  • de Araujo Nobre M, Moura Guedes C, Almeida R, Silva A, Sereno N. Hybrid Polyetheretherketone (PEEK)-Acrylic Resin Prostheses and the All-on-4 Concept: A Full-Arch Implant-Supported Fixed Solution with 3 Years of Follow-Up. J Clin Med. 2020 Jul 10;9(7):2187. doi: 10.3390/jcm9072187.

    PMID: 32664393RESULT

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of Prosthodontics

Study Record Dates

First Submitted

March 8, 2026

First Posted

March 16, 2026

Study Start

August 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)