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Completed

NCT Number: NCT05352620

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

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

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Key information

Conditions

Atrophic Maxilla Bone Diseases Bone Resorption Edentulous Jaw Jaw Diseases Jaw, Edentulous Maxillary Diseases Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. change in peri-implant probing depth

    Time frame: Baseline, 3 months, 6 months, 9 months

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

  2. Change in Clinical Attachment level

    Time frame: Baseline, 3 months, 6 months, 9 months

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

  3. Change in Implant Stability

    Time frame: at baseline and 9 months

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

  4. Change in alveolar bone level

    Time frame: at baseline and 9 months

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

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 29, 2022
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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