Four Locator Attachment Mandibular Overdentures

Bone Resorption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05910333
• Other study ID #: A0103023RP
• Status: Recruiting
• Start date: March 28, 2023
• Est. completion date: October 27, 2023

Study information

• Verified date: October 2023
• Source: Mansoura University
• Contact: Mohammed E Sawy, PhD
• Phone: +201061314522
• Email: Dr_sawy[@]windowslive.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 27, 2023
• Est. primary completion date: October 21, 2023
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Resorption

Intervention

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.

Locations

Country	Name	City	State
Egypt	Mohammed El Sawy	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Elsawy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Crestal bone loss around implants	amount of bone loss which appears on a periapical radiograph.	10 years
Primary	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	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