Vertical Versus Inclined Implant to Retain Locator Maxillary Overdenture

Bone Loss Clinical Trial

Official title:

Vertical Implant Versus Inclined Implant to Retain Locator Maxillary Overdenture : One Year Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05843331
• Other study ID #: A26060722
• Status: Completed
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: April 2, 2023

Study information

• Verified date: April 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objectives: evaluate the success rate, prosthetic maintenance , clinical and radiologic results of vertical implants with straight abutments versus inclined implants with angled abutments to retain locator maxillary overdentures. There were two groups : 1) The control group 2) The study group

Description:

the aim of the present investigation was to evaluate the success rate, prosthetic maintenance , clinical and radiologic results of vertical implants with straight abutments versus inclined implants with angled abutments to retain locator maxillary overdentures.

Materials and Methods conducted on 12 patients (6 males and 6 females) aged 58 to 68 years with completely edentulous maxillary ridges opposing implant-retained mandibular overdentures. Patients admit to the prosthodontic department, Faculty of Dentistry, Mansoura University for oral rehabilitation by implant-supported maxillary prostheses. Patients were allocated into one of two treatment groups: 1) The control group ; included 6 patients (3 males and 3 females) who will receive 4 vertical implants with straight trans mucosal abutments retaining locator maxillary overdenture 2) The study group; include 6 patients (3 males and 3 females) who will receive 4 inclined implants with angled trans mucosal abutments for retaining locator maxillary overdenture. Randomization and allocation of patients into treatment groups was made by dental personnel who is blind to treatment groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2, 2023
• Est. primary completion date: March 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 58 Years to 68 Years

Eligibility

Inclusion Criteria:

1. Unable to wear the upper denture

2. Radiographic diagnosis of bone loss

Exclusion Criteria:

1. Neuromuscular diseases

2. Insulin dependent diabetes

Related Conditions & MeSH terms

• Bone Loss
• Implant Complication

Intervention

Procedure:
• implants
Four implants in the maxilla with locator attachments

Locations

Country	Name	City	State
Egypt	Mansoura university	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

ELsyad MA, Abo Hatem OE, Shawky AF, Emera RMK. Effect of Different Degrees of Mesial Implant Inclination on the Retention and Stability of Two-Implant Mandibular Overdentures Retained with Stud Attachments: An In Vitro Study. Int J Oral Maxillofac Implants. 2018 March/April;33(2):259-268. doi: 10.11607/jomi.5791. Epub 2017 Oct 13. — View Citation

ELsyad MA, Emera RM, Ashmawy TM. Effect of Distal Implant Inclination on Dislodging Forces of Different Locator Attachments Used for Mandibular Overdentures: An In Vitro Study. J Prosthodont. 2019 Feb;28(2):e666-e674. doi: 10.1111/jopr.12710. Epub 2017 Nov 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plaque index	measure plaque around each implant using Mombelli indices	12 months
Primary	pocket depth	dental probe used to measure the depth of formed pocket around each implant	12 months
Primary	implant stability	stability of each implant measured using Osstell® device	12 months
Secondary	Radiographic outcome	measuring bone resorption using the long-cone standardized periapical radiography	12 months