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Clinical Trials/NL-OMON20945
NL-OMON20945
Recruiting
Not Applicable

Comparison of hybrid and moderate rough implants in periodontally compromised patients: a 3-year randomized clinical trail

ACTA Dental Research B.V., Gustav Mahlerlaan 3004, 1081 LA, Amsterdam, The Netherlands0 sites43 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peri-implantitis
Sponsor
ACTA Dental Research B.V., Gustav Mahlerlaan 3004, 1081 LA, Amsterdam, The Netherlands
Enrollment
43
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
ACTA Dental Research B.V., Gustav Mahlerlaan 3004, 1081 LA, Amsterdam, The Netherlands

Eligibility Criteria

Inclusion Criteria

  • Age at least 18 years
  • \-Provision of written informed consent
  • \-Agree to return for follow\-up visits after 1, 2 and 3 years
  • \-Periodontally compromised patients having a history of proximal attachment loss of \> 5mm in \> 30% of teeth present and enrolled in a supportive periodontal therapy (SPT) program after active periodontal treatment
  • \-Requirement of two single\-unit fixed partial dentures (FPDs supported by two implants in mandibular premolar and/or molar region
  • \-Adjacent natural tooth/teeth
  • \-In antagonistic jaw natural teeth, partial prosthesis, or implant supported (partial) prosthesis in contact with planned FPD
  • \-History of edentulism in planned implant area \> 4 months
  • \-At planned implant area, a minimum of 12 mm bone in vertical dimension and minimum of 6 mm in horizontal dimension available
  • \-Acquiring a primary stable implant situation assumed by investigator

Exclusion Criteria

  • \-History of local radiotherapy to the head and neck region
  • \-History of chemotherapy \< 5 years prior to surgery
  • \-Smoking \> 10 cigarettes a day
  • \-Uncontrolled diabetes mellitus
  • \-Known or suspected current malignancy
  • \-Pregnancy at time of inclusion
  • \-Alcohol or drug abuse
  • \-Any systemic or local disease that would compromise postoperative healing and/or osseointegration
  • \-Need for systemic bisphosphonates, corticosteroids or any other medication that would compromise postoperative healing and/or osseointegration
  • \-History of systemic bisphosphonates

Outcomes

Primary Outcomes

Not specified

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