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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prosthesis; Bone Loss, Alveolar; Prosthodontics; Implants, Dental
• Intervention / Treatment: Other: Titanium framework reinforced all on four prosthesis; Other: PEEK framework reinforced all on four prosthesis

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11251
      • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Titanium framework reinforced all on four prosthesis; Active Comparator: Titanium reinforced fixed all-on-four prosthesis	Other: Titanium 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
Other: PEEK framework reinforced all on four prosthesis	Other: PEEK framework reinforced all on four prosthesis; Fabricating a fixed prosthesis for patients with completely edentulous mandibles reinforced with PEEK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone density	Bone density around dental implants will be measured using digora digital radiographs which will be measured in hounsfield units.	12 months at intervals (0,3,6,9and 12 months)

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 8, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss
• Other Study ID Numbers: AO4-PEEKTi-MBL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No