Edentulous Maxilla Opposed by 2-implant Mandibular Overdenture?

Sponsor
Mansoura University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06050213
Collaborator
(none)
20
1
3
25.3
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Maxillary implant overdenture
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Maxillary Overdenture Retained by Different Number of Implants Opposed by 2-implant Assisted Mandibular Overdenture. A Cross-over Study of Patient Satisfaction
Actual Study Start Date :
Jun 8, 2022
Anticipated Primary Completion Date :
Dec 26, 2023
Anticipated Study Completion Date :
Jul 16, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Patient satisfaction [one year]

    patient satisfaction will be evaluated for all patients by a questionnaire using visual analogue scale

  2. Bite force [one year]

    Bite force will be evaluated for all patients by a digital bite force device

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura university Mansoura Dakahlia Egypt 35516

Sponsors and Collaborators

  • Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT06050213
Other Study ID Numbers:
  • A20080622
First Posted:
Sep 22, 2023
Last Update Posted:
Sep 22, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2023