Status:

UNKNOWN

Changes on the Interproximal Bone Level on Direct Prostheses or With Intermediate Abutments

Lead Sponsor:

University of Santiago de Compostela

Collaborating Sponsors:

Mozo Grau S.A.

Conditions:

Periimplant Bone Loss

Marginal Periimplant Bone Level

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Study Title: Changes on the Interproximal marginal bone level after CAD-CAM designed bridges directly placed on bone-level implants, or with intermediate abutments. A Randomized Clinical Trial. * Obj...

Detailed Description

Changes on the interproximal periimplant marginal bone level measured as the distance between the bone crest to the first implant to bone contact, using periapical radiographs, will be evaluated. Eac...

Eligibility Criteria

Inclusion

  • Patients with systemic and periodontal health, over 18 years old, with a Plaque Index lower than 25%.
  • Patients with an absence of at least two contiguous teeth, with natural proximal teeth, excluding the anterior upper zone, allowing the rehabilitation with bridges with two implants and two to four prostheses units
  • Adequate bone quality available that allows the placement of MOZO GRAU® INHEX ST implants with diameters of 3.75 mm or 4.25 mm and lengths of 8, 10 and 11.5 mm.
  • At least 2mm of keratinized gingiva.
  • Natural antagonic teeth or implants with fixed restorations.

Exclusion

  • • Systemic Factors:
  • Long term use of systemic medication that may interfere with bone metabolism or medical conditions that require prolonged use of steroids and / or medication that may interfere with bone metabolism
  • History of leukocyte dysfunction and deficiency, immunodeficiency syndromes, renal failure or bonemetabolic disorders such as osteoporosis
  • Physical disabilities that may interfere with proper oral hygiene
  • Use of any medication or device in research for a period of 30 days prior to the implant surgery in the study
  • Alcoholism or drug abuse
  • Smoker of more than 10 cigarettes per day
  • Conditions or circumstances which could prevent compliance with the participation in the study or interfere with the analysis of the results, such as a history of non-compliance or lack of reliability.
  • Local Factors:
  • History of local radiotherapy
  • Bruxism
  • Mucosal diseases, such as Oral Lichen Planus
  • Not treated periodontitis
  • Persistent intraoral infection
  • Crestal bone regeneration less than 3 months before the implant placement
  • Not healed extraction sockets (less than 6 weeks post-extraction
  • Anterior aesthetic sextant of the maxilla

Key Trial Info

Start Date :

April 25 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 25 2022

Estimated Enrollment :

37 Patients enrolled

Trial Details

Trial ID

NCT04369170

Start Date

April 25 2019

End Date

October 25 2022

Last Update

September 29 2021

Active Locations (1)

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University of Santiago de Compostela

Santiago de Compostela, La Coruña, Spain, 15782