Edentulous Maxilla Opposed by 2-implant Mandibular Overdenture?

Prosthesis Durability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06050213
• Other study ID #: A20080622
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 8, 2022
• Est. completion date: July 16, 2024

Study information

• Verified date: September 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: July 16, 2024
• Est. primary completion date: December 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prosthesis Durability
• Prosthesis Failure

Intervention

Device:
• Maxillary implant overdenture
maxillary overdenture retained by different number of implants

Locations

Country	Name	City	State
Egypt	Mansoura university	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction	patient satisfaction will be evaluated for all patients by a questionnaire using visual analogue scale	one year
Primary	Bite force	Bite force will be evaluated for all patients by a digital bite force device	one year