Clinical Study on the Efficiency of Three Different Attachment Systems for Implant-supported Mandibular Overdenture

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Concordia Dent Srl.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Concordia Dent Srl
ClinicalTrials.gov Identifier:
NCT01034930
First received: December 17, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

The aim of the investigators study is to compare, in a prospective controlled clinical trial, the Locator® System with two other types of stress-breaking retention (Retentive Anchors and Magnets) for implant supported overdenture in atrophic edentulous mandible, with the use of Straumann Dental Implant System.


Condition Intervention
MANDIBLE
Atrophyc Edentulous Jaw
Procedure: Insertion of dental implants

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 5-year Prospective Randomised Clinical Study on the Efficiency of Three Different Attachment Systems as Retention for Implant-supported Mandibular Overdenture.

Further study details as provided by Concordia Dent Srl:

Primary Outcome Measures:
  • The following parameters will be assessed for implant survival: - Gingiva-score, Plaque-score, Calculus, Bleeding-score, Probing pocket depth and Implant stability will be measured using Osstell (RFA). [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiographic outcome: Standardised intra-oral radiographs will be made using the long cone technique. Prosthetic maintenance and complications and soft-tissue complications of the denture bearing area will be recorded. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Patient satisfaction will be assessed with the aid of questionnaires: initial (with the original denture), after 6 months, 1-year and 5 years. Final costs for each type of retention will be calculated according to all the procedures and complications. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: August 2004
Estimated Study Completion Date: December 2012
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Retentive Anchors
23 patients will receive as retention system for overdentures Retentive Anchors (Straumann).
Procedure: Insertion of dental implants
Each patient will receive 2 screw-type Straumann (Institut Straumann AG, Basel, Switzerland) standard implants Ø4.1 mm, with SLA surface in the canine region of the mandible with an interconnecting line approaching parallelism with the terminal mandibular hinge axis, according to a standard surgical protocol.
Other Name: Mandibular overdenture metal reinforced will be made.
Active Comparator: Magnets
23 patients will receive Magnets (Straumann) as retention system for overdenture.
Procedure: Insertion of dental implants
Each patient will receive 2 screw-type Straumann (Institut Straumann AG, Basel, Switzerland) standard implants Ø4.1 mm, with SLA surface in the canine region of the mandible with an interconnecting line approaching parallelism with the terminal mandibular hinge axis, according to a standard surgical protocol.
Other Name: Mandibular overdenture metal reinforced will be made.
Active Comparator: Locator System
23 patients will receive Locator System (Straumann) as retention for the mandibular overdenture.
Procedure: Insertion of dental implants
Each patient will receive 2 screw-type Straumann (Institut Straumann AG, Basel, Switzerland) standard implants Ø4.1 mm, with SLA surface in the canine region of the mandible with an interconnecting line approaching parallelism with the terminal mandibular hinge axis, according to a standard surgical protocol.
Other Name: Mandibular overdenture metal reinforced will be made.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Complains about the stability of the existing mandibular denture satisfactory from a technical point of view.
  • Acceptance of a mandibular over-denture retained by two endosseous implants.
  • Patients agree to a 5-year follow-up period.

Exclusion Criteria:

  • Insufficient bone volume (height and with) for inserting at least a 10 mm implant (Ø 4,1).
  • Angle class II relationship.
  • Physical severe consideration that will affect the minimal invasive surgical procedure or constitute a hindrance for a 5-year follow-up.
  • History of radiotherapy in the head and neck region.
  • History of pre-prosthetic surgery (including bone graft procedures) or previous oral implants.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034930

Locations
Romania
Concordia Dent Clinic
Bucharest, Romania, 041335
Sponsors and Collaborators
Concordia Dent Srl
Investigators
Principal Investigator: CORINA MARILENA I CRISTACHE, DMD, PhD Concordia Dent Srl
  More Information

Publications:

Responsible Party: CORINA MARILENA CRISTACHE, DMD, PhD, CONCORDIA DENT SRL
ClinicalTrials.gov Identifier: NCT01034930     History of Changes
Other Study ID Numbers: 316/03-207-507
Study First Received: December 17, 2009
Last Updated: December 17, 2009
Health Authority: Romania: Ministry of Public Health

Keywords provided by Concordia Dent Srl:
MANDIBLE
IMPLANTS
OVERDENTURE

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw Diseases
Mouth Diseases
Mouth, Edentulous
Musculoskeletal Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on October 21, 2014