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Smart Box With OT Equator Attachment in Retaining Implant-assisted Overdenture for the Atrophic Maxilla.

Primary Purpose

Atrophic Maxilla, Edentulous Jaw

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Implant assisted maxillary overdenture

About this trial

This is an interventional treatment trial for Atrophic Maxilla

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male patients with comparable age (30- 65 years).
All patients should have retruded, posteriorly atrophic completely edentulous maxilla with sinus pneumatization leaving less than 7mm bone height posteriorly and a sufficient amount of bone in the inter bicuspids region.
Opposing mandibular dentate arch including bilateral posterior teeth.
All patients should have an adequate zone of keratinized mucosa.
All patients should be free from any intra-oral or systemic diseases that would otherwise affect the osseointegration of dental implants.
All patients should be well motivated, cooperative, and with adequate manual dexterity necessary to place and remove removable implant prosthesis to provide adequate oral hygiene around the endosseous implants.

Exclusion Criteria:

Patients with flabby maxillary ridges.
Patients who are unwilling to accept implant overdentures as a treatment modality.
Patients with temporomandibular and neuromuscular disorders.

Sites / Locations

Alexandria Faculty of Dentistry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implant assisted maxillary overdenture

Arm Description

Horseshoe Maxillary Complete overdenture construction (Stabilizing and connecting the Smart Box housing)

Outcomes

Primary Outcome Measures

change in peri-implant probing depth

The peri-implant sulcus depth will be measured using a graduated plastic periodontal probe.

Change in Clinical Attachment level

It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters

Change in Implant Stability

The Osstell unit records a numeric value of 1-100 which is referred to as the implant stability quotient (ISQ)

Change in alveolar bone level

The level of alveolar bone around each abutment will be evaluated using CBCT.

Secondary Outcome Measures

Full Information

NCT ID

NCT05352620

First Posted

April 23, 2022

Last Updated

April 23, 2022

Sponsor

Hams Hamed Abdelrahman

1. Study Identification

Unique Protocol Identification Number

NCT05352620

Brief Title

Smart Box With OT Equator Attachment in Retaining Implant-assisted Overdenture for the Atrophic Maxilla.

Official Title

Smart Box Accompanied With OT Equator Attachment in Retaining Immediately Loaded Inclined Implant Assisted Overdenture for Atrophic Maxilla

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

May 1, 2019 (Actual)

Study Completion Date

May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hams Hamed Abdelrahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The aim of the present study is to clinically and radiographically evaluate the effect of the use of recently developed Smart Box accompanied with OT Equator attachment in retaining of the inclined implant assisted overdenture for atrophic maxilla and to compare the vertical bone changes around axial implants with OT Equator attachment and inclined implants with smart box attachment radiographically using CBCT

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrophic Maxilla, Edentulous Jaw

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Implant assisted maxillary overdenture

Arm Type

Experimental

Arm Description

Horseshoe Maxillary Complete overdenture construction (Stabilizing and connecting the Smart Box housing)

Intervention Type

Other

Intervention Name(s)

Implant assisted maxillary overdenture

Intervention Description

For each patient, an implant assisted maxillary overdenture will be fabricated using a minimally invasive flapless surgical technique with OT-Equator and Smart Box attachment

Primary Outcome Measure Information:

Title

change in peri-implant probing depth

Description

The peri-implant sulcus depth will be measured using a graduated plastic periodontal probe.

Time Frame

Baseline, 3 months, 6 months, 9 months

Title

Change in Clinical Attachment level

Description

It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters

Time Frame

Baseline, 3 months, 6 months, 9 months

Title

Change in Implant Stability

Description

The Osstell unit records a numeric value of 1-100 which is referred to as the implant stability quotient (ISQ)

Time Frame

at baseline and 9 months

Title

Change in alveolar bone level

Description

The level of alveolar bone around each abutment will be evaluated using CBCT.

Time Frame

at baseline and 9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male patients with comparable age (30- 65 years). All patients should have retruded, posteriorly atrophic completely edentulous maxilla with sinus pneumatization leaving less than 7mm bone height posteriorly and a sufficient amount of bone in the inter bicuspids region. Opposing mandibular dentate arch including bilateral posterior teeth. All patients should have an adequate zone of keratinized mucosa. All patients should be free from any intra-oral or systemic diseases that would otherwise affect the osseointegration of dental implants. All patients should be well motivated, cooperative, and with adequate manual dexterity necessary to place and remove removable implant prosthesis to provide adequate oral hygiene around the endosseous implants. Exclusion Criteria: Patients with flabby maxillary ridges. Patients who are unwilling to accept implant overdentures as a treatment modality. Patients with temporomandibular and neuromuscular disorders.

Facility Information:

Facility Name

Alexandria Faculty of Dentistry

City

Alexandria

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

Smart Box With OT Equator Attachment in Retaining Implant-assisted Overdenture for the Atrophic Maxilla.

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