A 5-year Prospective Randomised Clinical Study on the Efficiency of Three Different Attachment Systems as Retention for Implant-supported Mandibular Overdenture.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Concordia Dent Srl
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- 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).
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Retentive Anchors
23 patients will receive as retention system for overdentures Retentive Anchors (Straumann).
Intervention: Insertion of dental implants (Procedure)
Magnets
23 patients will receive Magnets (Straumann) as retention system for overdenture.
Intervention: Insertion of dental implants (Procedure)
Locator System
23 patients will receive Locator System (Straumann) as retention for the mandibular overdenture.
Intervention: Insertion of dental implants (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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.(5 years)
- 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.(5 years)
Investigators
Corina Marilena Cristache
Dr Corina Marilena Cristache, DMD, PhD, senior lecturer
Concordia Dent Srl