Retention and Wear Characteristic Assessment of OT Equator Smart Box Attachment

January 21, 2021 updated by: Doaa Amr Heshmat, Cairo University

Retention and Wear Characteristic Assessment of OT Equator Smart Box Attachment Versus Ball Attachment for Mandibular Two Implant Assisted Over Denture , In-vitro Study

This research aimed to evaluate the retentive power and wear of the smart box attachment use with tilted two implant assisted mandibular overdenture

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Implant supported overdenture can provide better mastication force than complete denture but less than the normal teeth . Most of the patient reported that implant supported overdenture has many superior features over the conventional complete denture in stability and retention Key factors related to successful treatment with overdentures include the number, location, and distribution of implants and choice of abutment. While the use of parallel implants that are widely distributed is generally desirable for optimal treatment, patients often present with challenging anatomical features, insufficient bone volume in all dimensions, and/or critical anatomy that precludes ideal placement of dental implants. Some clinicians may consider the ideal placement of implants for overdentures as parallel to each other and perpendicular to the occlusal plane of the denture Anatomical features associated with mandibular or maxillary edentulous ridges can range from straight or rounded to irregular and sharp ridges, and variability in bone width may limit potential implant sites for overdentures. Factors such as narrow bone volume, the inferior alveolar nerve being anterior or superior positioned, extensive bony undercuts, the inferior portion of the maxillary sinus, proximity to high-risk vascular structures, or a patient's desire to avoid additional surgical procedures may prompt a clinician to angulate a dental implant, which could result in the positioning of implants in non-ideal configurations.

Excessive angulation, increased maintenance and wear of inserts, and difficulty maintaining hygiene. Increased angulation may result in greater challenges to inserting and removing the prosthesis, which can become difficult for patients who are older and/or have limited dexterity. This challenge also can make it hard for patients to properly clean the inside of the retentive portion of the stud-style abutment and may increase wear of the retentive inserts Resilient Ball attachment most commonly used Ball attachment the simplest of all stud attachments which widely used because it is practical, effective, relatively low cost, less technique sensitive, ease of handling, minimal chair side time requirements and their possible applications with both root and implant-supported prostheses so it is used with non-splinted implants in clinical studies, it has been shown that changes in the retention of the prostheses occurred frequently. Both decrease and considerable increase in retention occurred as a result of attachment abrasion and micro movements during the mastication process The ball attachments showed only a few minor, easy manageable complications. Four out of 36 attachments gave reason for treatment. Two matrices loosened out of the mandibular denture and had to be fastened by adding acrylic resin after 1 and 4 weeks of loading. One patrix part of the ball attachment unsettled after 2 days of loading and was refastened. One ball attachment matrix lost its retention capacity and had to be reactivated after a period of 2 weeks. All these complications occurred in subjects where the implants were not perfectly parallel to each other positioned in the mandible. The loading conditions of these attachments were therefore not as favorable as for more parallel inserted implants A lack of parallelism of the implants creates considerable wear of the rubber rings in a relatively short time span.

Rhein 83, Italy, also has developed Smart Box, which could be used with the OT Equator in patients of extreme divergencies among the implants. The Smart Box has an inner tilting mechanism that enables a passive insertion with divergent implants up to 50 degrees(159).

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

10 mandibular edentolous casts

Description

Inclusion Criteria:

  • mandibular cast

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Equator attachment
Implant installation over epoxy resin model at the canine area on both sides following the surgical protocol of the implant placement,Equator Attachment fabrication is firmly screwed to the fixture on both sides at the canine region
This research aimed to evaluate the retentive power and wear of the smart box attachment use with tilted two implant assisted mandibular overdenture
ball attachment
Implant installation over epoxy resin model at the canine area on both sides following the surgical protocol of the implant placement,ball Attachment fabrication is firmly screwed to the fixture on both sides at the canine region
This research aimed to evaluate the retentive power and wear of the smart box attachment use with tilted two implant assisted mandibular overdenture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention
Time Frame: 6 month
Retention of OT equator smart box attachment versus ball attachment for mandibular two implant assisted over denture
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wear evaluation
Time Frame: 6 month
wear evaluation of OT equator smart box attachment versus ball attachment for
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2021

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

January 16, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • equator implant attachment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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