ClinicalTrials.gg
RecruitingNCT05910333Updated Oct 23, 2023

Four Locator Attachment Mandibular Overdentures

An observational study in Bone Resorption, sponsored by Mohamed Elsawy. Recruiting at 1 site in Egypt. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-23.

Sponsored by Mohamed Elsawy · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 7 months later.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
20
Ages
55 Years to 80 Years
Sex
All
01

Study summary

. There is little information on the degree of crestal bone loss around 4 inter-foraminal implant-retained mandibular overdentures (OVDs) and the amount of bone remodelling on the anterior maxilla and posterior mandibule on long-term function, particularly with different distributions.

Read the detailed description

Numerous studies confirm the successful use of implants to retain prostheses in the edentulous atrophic mandible. It has been recommended by some authors that clinicians should use 3 or 4 implants in situations that require increased retention, such as high muscle attachment or prominent mylohyoid ridge. LOCATOR attachment as a retentive component has several advantages over other systems, Such as: dual retention through both external and internal mating surfaces, a self-aligning feature which is helpful in guiding patients when placing their denture. There is little information on the degree of crestal bone loss around 4 inter-foraminal implant-retained mandibular overdentures (OVDs) and the amount of bone remodelling on the anterior maxilla and posterior mandibule on long-term function, particularly with different distributions.

02

Conditions studied

  • Bone Resorption

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03

In context

Bone Resorption

167 studies on the registry are indexed under Bone Resorption; 28 are open to participants now.

This study's planned enrollment of 20 is below the median of 43 across 18 observational studies indexed under Bone Resorption.

Browse Bone Resorption studies →

Lead sponsor

This is the only study on the registry with Mohamed Elsawy as lead sponsor.

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

04

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

10 patients in each group. total number of patients 20.

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

  • Patients with 4 implants in the inter-foraminal region.
  • Patients treated by staff and students in the Master's program in Prosthodontics Department according to the following criteria:
  • Edentulous maxilla and mandible for at least 1 year.
  • Problems with retention and stability of the mandibular denture.
  • Mandibular bone height between 15 and 25 mm.

Exclusion criteria

Exclusion Criteria:

  • Patients with relative , such as
  • A history of para functional habits.
  • Smokers more than 10 cigarettes per day.
  • alcoholism.
  • Patients with a history of radiation therapy in the head and neck region . • Patients within intravenous administrated bisphosphonates., chemotherapy, and mental disorders that could jeopardies their co-operation.
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

Observational model
Other
Time perspective
Retrospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Quadrilateral distribution group

    Patients with quadrilateral distribution of implants

    Other: observation

  • Linear distribution group

    Patients with lineardistribution of implants

    Other: observation

Interventions

  • Otherobservation

    To compare the effect of the mandibular implant retained OVD using quadrilateral distribution (QD) versus linear distribution (LD) on posterior mandibular ridge resorption (PMandRR), anterior maxillary ridge resorption (AMaxRR), and changes to the crestal bone level around implants after 10 years of function.

06

What researchers measure

Primary outcomes

  1. Posterior mandibular ridge resorption (PMandRR)

    The amount of PMandRR will be assessed using posterior area index on a panoramic x-ray which use specific landmarkds.

    Time frame: 10 years retrospective study

Secondary outcomes

  1. Anterior maxillary ridge resorption (AMaxRR)

    The amount of PMandRR will be assessed using anterior area index on a panoramic x-ray, which use specific landmarks.

    Time frame: 10 years

Other outcomes

  1. Crestal bone loss around implants

    amount of bone loss which appears on a periapical radiograph.

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — just by contacting the corresponding author

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2023 (actual). Primary completion is estimated for Oct 2023, 6 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 9, 2023
First posted
Jun 18, 2023
StartActual
Mar 28, 2023
Primary completionEst.
Oct 21, 2023
CompletionEst.
Oct 27, 2023
Last update
Oct 23, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05910333
Lead sponsor
Mohamed Elsawy
Responsible party
Mohamed Elsawy (lecturer, Department of prosthodontics, principle investigator, Mansoura University) — Sponsor-investigator
First posted
Jun 18, 2023
Start date
Mar 28, 2023
Primary completion
Oct 21, 2023 (estimated)
Completion
Oct 27, 2023 (estimated)
Last update
Oct 23, 2023

Study contacts

Mohammed E Sawy, PhD
Contact
Dr_sawy@windowslive.com
+201061314522
Salah A. Hegazy, PhD
Contact
salahhegazy@yahoo.com
+01227690209
Mohammed E Sawy
study director · Mansoura University

Oversight

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

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