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Effect of PEEK and Titanium Framework Reinforcement on Marginal Bone Loss Around Implants Supporting a Fixed All-on-four Prosthesis in Completely Edentulous Mandibles

Effect of PEEK and Titanium Framework Reinforcement on Marginal Bone Loss Around Implants Supporting a Fixed All-on-four Prosthesis in Completely Edentulous Mandibles. A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07475507
Enrollment
20
Registered
2026-03-16
Start date
2024-08-01
Completion date
2027-03-01
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Loss, Alveolar, Implants, Dental, Prosthesis, Prosthodontics

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.

Interventions

OTHERTitanium framework reinforced all on four prosthesis

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

OTHERPEEK framework reinforced all on four prosthesis

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

1. Completely edentulous patients requesting a fixed, implant supported restoration. 2. Patients aged from 45 to 60, able to sign an informed consent will be considered eligible for this trial. 3. Implant sites must allow the placement of four implants. 4. Non- heavy Smokers will be included (smoking up to 10 cigarettes/day) 5. In case of post-extraction sites, they must have been healed for at least 3 months before being treated in the study. 6. Patients with no systemic condition that may interfere with implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino-bisphosphonates) \-

Exclusion criteria

1. Patients with poor oral hygiene and motivation. 2. Female patients taking any medical treatment for management of osteoporosis. 3. Drug abusers. 4. Psychiatric problems or unrealistic expectations. 5. Patients with active infection or inflammation in the planned implant area at the time of implant placement. 6. Immuno-compromised patients (Diabetic with HBA1C \> 7 or patients undergoing chemo or radiotherapy or bisphosphonates)

Design outcomes

Primary

MeasureTime frameDescription
Marginal bone loss12 months at intervals (0,3,6,9and 12 months)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.

Secondary

MeasureTime frameDescription
Bone density12 months at intervals (0,3,6,9and 12 months)Bone density around dental implants will be measured using digora digital radiographs which will be measured in hounsfield units.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026