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

NCT05352620 | Completed

• 1 other identifier: Overdenture_2022
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Atrophic Maxilla; Edentulous Jaw

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Change in alveolar bone level

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

  at baseline and 9 months

Study Arms (1)

Implant assisted maxillary overdenture

EXPERIMENTAL

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

Other: Implant assisted maxillary overdenture

Interventions

Implant assisted maxillary overdenture OTHER

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

Implant assisted maxillary overdenture

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

MeSH Terms

Conditions

Atrophic Maxilla; Jaw, Edentulous

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Maxillary Diseases; Jaw Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: April 23, 2022
• First Posted: April 29, 2022
• Study Start: March 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

EG (1)