Ten Years Retrospective Study of 4 LOCATOR Mandibular Overdentures.

Sponsor
Mohamed Elsawy (Other)
Overall Status
Recruiting
CT.gov ID
NCT05910333
Collaborator
(none)
20
1
2.4
8.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: observation

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Ten Years Retrospective Study of 4 LOCATOR Attachment of Mandibular Implant Retained Overdenture With 2 Different Distributions.
Actual Study Start Date :
Mar 28, 2023
Anticipated Primary Completion Date :
Jun 8, 2023
Anticipated Study Completion Date :
Jun 8, 2023

Arms and Interventions

Arm Intervention/Treatment
Quadrilateral distribution group

Patients with quadrilateral distribution of implants

Other: observation
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.

Linear distribution group

Patients with lineardistribution of implants

Other: observation
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.

Outcome Measures

Primary Outcome Measures

  1. To compare the effect of the mandibular implant retained OVD using quadrilateral distribution versus linear distribution. [10 years retrospective study]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 80 Years
Sexes Eligible for Study:
All
Inclusion Criteria:

Patients with 4 implants in the interforaminal region. These patients had been 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, a mandibular bone height between 15 and 25 mm.

Exclusion Criteria:
  • Patients with relative contraindications, such as a history of para functional habits, smokers more than 10 cigarettes per day, and alcoholism. Patients with a history of radiation therapy in the head and neck region. Also, patients within intravenous administrated bisphosphonates, chemotherapy, and psychological disorders that could jeoparadise their co-operation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mohammed El Sawy Multiple Locations Egypt 12345

Sponsors and Collaborators

  • Mohamed Elsawy

Investigators

  • Study Director: Mohammed E Sawy, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Elsawy, Ten years retrospective study of 4 LOCATOR attachment of mandibular implant retained overdenture with 2 different distributions, Mansoura University
ClinicalTrials.gov Identifier:
NCT05910333
Other Study ID Numbers:
  • A0103023RP
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 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 Jun 18, 2023