ClinicalTrials.gg
Enrolling by invitationNCT06050213Updated Sep 22, 2023

Edentulous Maxilla Opposed by 2-implant Mandibular Overdenture?

An interventional study of Maxillary implant overdenture in Prosthesis Durability, sponsored by Mansoura University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-22.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as enrolling by invitation.
  • Registered 1 year 3 months after the study started (first participant enrolled Jun 2022, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Prosthesis Durability

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03

In context

Prosthesis Failure

119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.

This study's planned enrollment of 20 is below the median of 36 across 69 interventional studies indexed under Prosthesis Failure.

Browse Prosthesis Failure studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 for implant placement due to localized bone defects and poor bone quality (D5).
    • Patients with TMJ disorders or poor neuromuscular coordination.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    three implant group

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

    Device: Maxillary implant overdenture

  • Active comparator
    five implant group

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

    Device: Maxillary implant overdenture

  • Active comparator
    four implant group

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

    Device: Maxillary implant overdenture

Interventions

  • DeviceMaxillary implant overdenture

    maxillary overdenture retained by different number of implants

06

What researchers measure

Primary outcomes

  1. Patient satisfaction

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

    Time frame: one year

  2. Bite force

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

    Time frame: one year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06050213
Responsible party
Sponsor
First posted
Sep 22, 2023
Start date
Jun 8, 2022
Primary completion
Dec 26, 2023 (estimated)
Completion
Jul 16, 2024 (estimated)
Last update
Sep 22, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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