Edentulous Maxilla Opposed by 2-implant Mandibular Overdenture?

Mansoura University

Status: Invitation-only

Conditions: Prosthesis Durability

Treatments: Device: Maxillary implant overdenture

Study type: Interventional

Funder types: Other

Identifiers

NCT06050213

A20080622

Details and patient eligibility

About

This within -subject study will be conducted to evaluate the proper number of unsplinted implants ;( three, four and five implants) for the edentulous maxilla opposed by mandibular two-implant overdentures.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• o Healthy and free from any systemic diseases that may interfere with the osseointegration of implants.

  • Patients have completely edentulous maxilla for at least 6 months after last extraction with opposing mandibular two-implant Overdentures.
  • The patients have angle class I maxillomandibular skeletal relation and sufficient interarch space not less than (10-12 mm) as detected by tentative jaw relation.
  • Maxillary and mandibular alveolar ridges covered with healthy, firm, relatively even thickness and even compressible mucosa as detected by palpation with the blunt end of the mirror and free from any signs of inflammation or flabbiness as detected by clinical examination.
  • Good quality and quantity of maxillary residual alveolar ridge, as detected by CBCT, available for implant width (3.7mm, 5mm for anterior and posterior implants respectively) and length (12mm, 10mm for anterior and posterior implants respectively) this was ascertained by CBCT.

Exclusion criteria

• o Any history of metabolic or systemic diseases that may affect integration of implant or connective tissue health surrounding implant.

  • History of irradiation in head-and-neck area.
  • Heavy smokers (more than 10 cigarettes per day)
  • Parafunctional habits such as bruxism.
  • Psychiatric disorders or unrealistic expectations.
  • Positive pregnancy test up to 5 days before surgery.
  • Severe thrombocytopenia and bleeding disorders.
  • Pathologic condition of soft tissue (bacterial and viral stomatitis, hyperplasia, cyst, fibrous lesions)
  • Patients with local contraindications for implant placement due to localized bone defects and poor bone quality (D5).
  • Patients with TMJ disorders or poor neuromuscular coordination.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 3 patient groups

three implant group

Active Comparator group

Description:

Maxillary overdenture retained by 3 unsplinted implants in midline and canines regions.

Treatment:

Device: Maxillary implant overdenture

five implant group

Active Comparator group

Description:

Maxillary overdenture retained by 5 unsplinted implants in midline, canines and molar regions.

Treatment:

Device: Maxillary implant overdenture

four implant group

Active Comparator group

Description:

Maxillary overdenture retained by 4 unsplinted implants in canines and molar regions.

Treatment:

Device: Maxillary implant overdenture