Edentulous Maxilla Opposed by 2-implant Mandibular Overdenture?

NCT ID: NCT06050213

Last Updated: 2023-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-08

Study Completion Date

2024-07-16

Brief Summary

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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.

Detailed Description

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Conditions

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Prosthesis Durability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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three implant group

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

Group Type ACTIVE_COMPARATOR

Maxillary implant overdenture

Intervention Type DEVICE

maxillary overdenture retained by different number of implants

five implant group

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

Group Type ACTIVE_COMPARATOR

Maxillary implant overdenture

Intervention Type DEVICE

maxillary overdenture retained by different number of implants

four implant group

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

Group Type ACTIVE_COMPARATOR

Maxillary implant overdenture

Intervention Type DEVICE

maxillary overdenture retained by different number of implants

Interventions

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Maxillary implant overdenture

maxillary overdenture retained by different number of implants

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mansoura university

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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A20080622

Identifier Type: -

Identifier Source: org_study_id

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