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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

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
20
Ages
55 Years to 80 Years
Sex
All
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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

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.

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 contraindications, 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.
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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.

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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

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Study locations

1 of 1 sites recruiting
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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.

08

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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