Vertical Versus Inclined Implant to Retain Locator Maxillary Overdenture

NCT ID: NCT05843331

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2023-04-02

Brief Summary

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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

Detailed Description

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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.

Conditions

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Implant Complication Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled clinical trial study conducted on 12 participants with completely edentulous maxillary ridges. 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 participants (3 males and 3 females) who will receive 4 inclined implants with angled trans mucosal abutments for retaining locator maxillary overdenture. A new maxillary conventional dentures will be constructed with a bilateral balanced occlusal concept for all patients. Maxillary dentures were duplicated into heat cure acrylic resin dentures to be used as a radiographic template. Four implants were inserted in the maxilla . For both groups, locator abutments were screwed to the abutments .Clinical and radiographic evaluations were done.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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posterior vertical implants

the anterior implants were inserted in the canine/lateral incisor area bilaterally to each other's following the contour of the alveolar bone of the premaxilla. The posterior implants were inserted vertically just anterior to the maxillary sinus (in the area of second premolars) .

Group Type ACTIVE_COMPARATOR

implants

Intervention Type PROCEDURE

Four implants in the maxilla with locator attachments

posterior inclined implants

The anterior implants were inserted in the canine/lateral incisor area bilaterally to each other's and will be inclined 15o labially following the contour of the alveolar bone of the premaxilla. The posterior implants were inserted just anterior to the maxillary sinus (in the area of second premolars) and inclined 15o distally .

Group Type ACTIVE_COMPARATOR

implants

Intervention Type PROCEDURE

Four implants in the maxilla with locator attachments

Interventions

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implants

Four implants in the maxilla with locator attachments

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Unable to wear the upper denture
2. Radiographic diagnosis of bone loss

Exclusion Criteria

1. Neuromuscular diseases
2. Insulin dependent diabetes
Minimum Eligible Age

58 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marwa Aboelez, Phd

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Mostafa Elsyad, Phd

Role: STUDY_CHAIR

Mansoura University

Locations

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Mansoura university

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 29143403 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29028850 (View on PubMed)

Other Identifiers

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A26060722

Identifier Type: -

Identifier Source: org_study_id

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