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

Edentulous Jaw Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05352620
• Other study ID #: Overdenture_2022
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: April 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophic Maxilla
• Atrophy
• Edentulous Jaw
• Jaw, Edentulous

Intervention

Other:
• Implant assisted maxillary overdenture
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

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in peri-implant probing depth	The peri-implant sulcus depth will be measured using a graduated plastic periodontal probe.	Baseline, 3 months, 6 months, 9 months
Primary	Change in Clinical Attachment level	It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters	Baseline, 3 months, 6 months, 9 months
Primary	Change in Implant Stability	The Osstell unit records a numeric value of 1-100 which is referred to as the implant stability quotient (ISQ)	at baseline and 9 months
Primary	Change in alveolar bone level	The level of alveolar bone around each abutment will be evaluated using CBCT.	at baseline and 9 months