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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Prosthesis Durability
• Intervention / Treatment: Device: Maxillary implant overdenture

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

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35516
      • Mansoura University

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: three implant group; Maxillary overdenture retained by 3 unsplinted implants in midline and canines regions.	Device: Maxillary implant overdenture; maxillary overdenture retained by different number of implants
Active Comparator: five implant group; Maxillary overdenture retained by 5 unsplinted implants in midline, canines and molar regions.	Device: Maxillary implant overdenture; maxillary overdenture retained by different number of implants
Active Comparator: four implant group; Maxillary overdenture retained by 4 unsplinted implants in canines and molar regions.	Device: Maxillary implant overdenture; maxillary overdenture retained by different number of implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	patient satisfaction will be evaluated for all patients by a questionnaire using visual analogue scale	one year
Bite force	Bite force will be evaluated for all patients by a digital bite force device	one year

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Estimated): December 26, 2023
• Study Completion (Estimated): July 16, 2024

Study Registration Dates

• First Submitted: September 17, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: A20080622

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