Edentulous Maxilla Opposed by 2-implant Mandibular Overdenture?

NCT06050213 | Unknown

• 1 other identifier: A20080622
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosthesis Durability

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

three implant group

ACTIVE COMPARATOR

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

Device: Maxillary implant overdenture

five implant group

ACTIVE COMPARATOR

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

Device: Maxillary implant overdenture

four implant group

ACTIVE COMPARATOR

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

Device: Maxillary implant overdenture

Interventions

Maxillary implant overdenture DEVICE

maxillary overdenture retained by different number of implants

five implant group; four implant group; three implant group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: September 22, 2023
• Study Start: June 8, 2022
• Primary Completion: December 26, 2023
• Study Completion: July 16, 2024
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)