Ignite Creation Date:
2024-05-05 @ 10:07 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01034930
Status:
COMPLETED
Last Update Posted:
2015-02-04
First Post:
2009-12-17
Brief Title:
Clinical Study on the Efficiency of Three Different Attachment Systems for Implant-supported Mandibular Overdenture
Sponsor:
Concordia Dent Srl
Organization:
Concordia Dent Srl
Study Overview
Official Title:
A 5-year Prospective Randomised Clinical Study on the Efficiency of Three Different Attachment Systems as Retention for Implant-supported Mandibular Overdenture
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Treatment procedure Each patient will receive 2 screw-type Straumann Institut Straumann AG Basel Switzerland standard implants Ø41 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 012 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 - B2 - 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
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 Ø41 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 012 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 - B2 - 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None