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.

  Hide Detailed Description

Detailed Description:

The study was divided in two parts - in the first part of the study 46 fully mandibular edentulous patients will be enrolled. The patients will be recruited from the University Hospital of Dentistry and 9 other private practices in Bucharest and surrounding areas.

Selected patients will be informed about the two different treatment options, about the benefit of treatment with an overdenture retained by two endosseous implants and a written informed consent will be obtained from all participants.

Initial examination

At the beginning of the treatment for each patient will be recorded:

  • The medical status.
  • The dental history, oral and radiographic examination.
  • The hygiene status.
  • An evaluation of the existing dentures.
  • The estimation of dysfunctional problems.

Treatment procedure 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. The implant lengths will be 10mm and 12mm. The choice of implant length will be dictated by the preoperative radiographic assessment of bone height in the canine region and drilling distance with the principal concern achieving primary stability.

The implants will be inserted under local anaesthesia using a surgical template derived from a tooth wax-up. The implants will be placed in a 1-stage non-submerged procedure according to a strict protocol (Weingart D and ten Bruggenkate 2000). Postoperatively, antibiotics for 5 days treatment (Amoxicillin and Clavulanate Potassium or Erytromycin - for patients alergic to Penicillin), analgesics and Clorhexidine 0,12% mouth rinse will be prescribe for 14 days. Patients will not be allowed to wear the mandibular denture during the first two weeks post-operatively.

One, two and four weeks after the surgical procedure, the patients will be recalled for follow-up visits. At the first recall visit, sutures will be removed. At the second visit the lower denture will be adjusted by selective grinding at the implant location, and Protefix® (Queisser Pharma Germany) Adhesive Cushions will be provided for patients. At all recall visits, patients will receive oral hygiene instructions.

At the third follow-up visit the manufacturing of a new maxillary denture (for the full maxillary edentulous patients) and a mandibular over-denture will be initiated.

After 6 weeks healing period implants will be loaded and the patients will be randomly assigne to one of two main groups:

  • Group B of 23 patients will receive retentive anchors (Institut Straumann AG, Basel, Switzerland).
  • Group M of 23 patients will receive magnets (Titanmagnetics® Institut Straumann AG, Basel, Switzerland ).

Group B will be randomly divided in two subgroups: full lower denture with two gold matrices with variable retention (four lamellae functioning like a spring - 12 patients and full lower denture with two titanium matrices with defined retention (spring with a defined extraction force of 700-1100g - B.2) - 11 patients. A new mandibular overdenture with metal reinforcement will be made.

The two groups of patients will be compared in the second part of the study with 23 patients receiving Locator system abutments (Group L) following same research protocol.

A new mandibular overdenture with metal reinforcement will be made.

The prosthetic procedure will be performed according the recommendations of the producer (Straumann Dental Implant System) for retentive anchors, magnets and Locator System by experienced prosthodontists. The occlusion will be assessed on the articulator and intra-orally to secure a balanced occlusion in centric relation without anterior tooth contact.

  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
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth, Edentulous
Mouth Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on September 18, 2014