Four Locator Attachment Mandibular Overdentures

Ten Years Retrospective Study of 4 LOCATOR Attachment of Mandibular Implant Retained Overdenture With 2 Different Distributions.

. 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 Overview

• Status: Recruiting
• Conditions: Bone Resorption
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Mohammed E Sawy, PhD; Phone Number: +201061314522; Email: Dr_sawy@windowslive.com
• Study Contact Backup: Name: Salah A. Hegazy, PhD; Phone Number: +01227690209; Email: salahhegazy@yahoo.com

Study Locations

• Egypt
  • Multiple Locations, Egypt, 12345
    • Recruiting
    • Mohammed El Sawy
    • Contact: Mohammed E Sawy, PhD; Phone Number: +201061314522; Email: Dr_sawy@windowslive.com
    • Contact: Salah A. Hegazy, PhD; Phone Number: +01227690809; Email: salahhegazy2003@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years retrospective study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crestal bone loss around implants	amount of bone loss which appears on a periapical radiograph.	10 years

Collaborators and Investigators

• Sponsor: Mohamed Elsawy
• Investigators: Study Director: Mohammed E Sawy, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Estimated): October 21, 2023
• Study Completion (Estimated): October 27, 2023

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: A0103023RP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: just by contacting the corresponding author

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No