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Edentulous Maxilla Opposed by 2-implant Mandibular Overdenture?

Primary Purpose

Prosthesis Durability

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Maxillary implant overdenture
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prosthesis Durability

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mansoura university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

three implant group

five implant group

four implant group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Patient satisfaction
patient satisfaction will be evaluated for all patients by a questionnaire using visual analogue scale
Bite force
Bite force will be evaluated for all patients by a digital bite force device

Secondary Outcome Measures

Full Information

First Posted
September 17, 2023
Last Updated
September 21, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT06050213
Brief Title
Edentulous Maxilla Opposed by 2-implant Mandibular Overdenture?
Official Title
Maxillary Overdenture Retained by Different Number of Implants Opposed by 2-implant Assisted Mandibular Overdenture. A Cross-over Study of Patient Satisfaction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 8, 2022 (Actual)
Primary Completion Date
December 26, 2023 (Anticipated)
Study Completion Date
July 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis Durability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
three implant group
Arm Type
Active Comparator
Arm Description
Maxillary overdenture retained by 3 unsplinted implants in midline and canines regions.
Arm Title
five implant group
Arm Type
Active Comparator
Arm Description
Maxillary overdenture retained by 5 unsplinted implants in midline, canines and molar regions.
Arm Title
four implant group
Arm Type
Active Comparator
Arm Description
Maxillary overdenture retained by 4 unsplinted implants in canines and molar regions.
Intervention Type
Device
Intervention Name(s)
Maxillary implant overdenture
Intervention Description
maxillary overdenture retained by different number of implants
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
patient satisfaction will be evaluated for all patients by a questionnaire using visual analogue scale
Time Frame
one year
Title
Bite force
Description
Bite force will be evaluated for all patients by a digital bite force device
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Mansoura university
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Edentulous Maxilla Opposed by 2-implant Mandibular Overdenture?

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