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Edentulous Maxilla Opposed by 2-implant Mandibular Overdenture?

Maxillary Overdenture Retained by Different Number of Implants Opposed by 2-implant Assisted Mandibular Overdenture. A Cross-over Study of Patient Satisfaction

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06050213
Enrollment
20
Registered
2023-09-22
Start date
2022-06-08
Completion date
2024-07-16
Last updated
2023-09-22

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

Conditions

Prosthesis Durability

Brief summary

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.

Interventions

maxillary overdenture retained by different number of implants

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient satisfactionone yearpatient satisfaction will be evaluated for all patients by a questionnaire using visual analogue scale
Bite forceone yearBite force will be evaluated for all patients by a digital bite force device

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026