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NCT Number: NCT07475507

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 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prosthodontics Alveolar Bone Loss Bone Diseases Bone Loss, Alveolar Bone Resorption Implants, Dental Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Prosthesis Stomatognathic Diseases

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, 11251, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

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Exclusion criteria

  • 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)

Treatment and study plan

Titanium framework reinforced all on four prosthesis

Other

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

PEEK framework reinforced all on four prosthesis

Other

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

Primary outcomes

  1. Marginal bone loss

    Time frame: 12 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 outcomes

  1. Bone density

    Time frame: 12 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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