Back to resultsEvaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic Connection
Primary Purpose
Jaw, Edentulous, Partially
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ziacom Galaxy dental implant with internal connical prosthetic connection
Ziacom Zinic dental implant with internal hexagonal prosthetic connection
Sponsored by
About this trial
This is an interventional treatment trial for Jaw, Edentulous, Partially
Eligibility Criteria
Inclusion Criteria: One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal). Exclusion Criteria: One-stage bone augmentation. Uncontrolled type 1 or 2 diabetes (HgA1c>8). Known auto-immune or inflammatory disease. Severe hematologic disorders, such as hemophilia or leukemia. Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology). Liver or kidney dysfunction/failure. Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy. Long-term history of oral bisphosphonates use (i.e., 10 years or more). History of intravenous bisphosphonates. Long-term (>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system 3 months before inclusion. Severe osseous diseases (e.g., Paget disease of bone). Pregnant women or nursing mothers. Not able or not willing to follow instructions related to the study procedures.
Sites / Locations
- Universidad de GranadaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ziacom Galaxy dental implant with internal connical prosthetic connection
Ziacom Zinic dental implant with internal hexagonal prosthetic connection
Arm Description
Placement and restoration of a single Ziacom Galaxy dental implant with internal connical prosthetic connection
Placement and restoration of a single Ziacom Zinic dental implant with internal hexagonal prosthetic connection
Outcomes
Primary Outcome Measures
Marginal bone level
Secondary Outcome Measures
Peri-implant microbiome
Relative abundance of microbial species in the peri-implant sulcus evaluated by next-generation sequencing methods
Peri-implant inflammation
Concentration of pro-inflammatory markers in the peri-implant sulcus evaluated by multiplex techniques methods
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05859113
Brief Title
Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic Connection
Official Title
Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic Connection
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Dental implants may suffer from bone loss around them, particularly at the upper portion where the prosthesis starts. The connection between both parts of the tooth restoration is key for avoiding micromovement during chewing, bacterial contamination and initiation of bone loss. Thus, investigating factors related to this bone loss in different types of implant-prosthetic connections is key for promoting better use of available therapeutics devices. In this study, we will study marginal bone levels over time as well as bacterial contamination and inflammatory markers in the peri-implant sulcus around implants with connical connection and compare them with those obtained when using implants with internal hexagonal connection. The hypothesis is that bone loss will be higher in implants with hexagonal connection associated with a pathological microbiome in the sulcus that induces a higher inflammatory response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ziacom Galaxy dental implant with internal connical prosthetic connection
Arm Type
Experimental
Arm Description
Placement and restoration of a single Ziacom Galaxy dental implant with internal connical prosthetic connection
Arm Title
Ziacom Zinic dental implant with internal hexagonal prosthetic connection
Arm Type
Active Comparator
Arm Description
Placement and restoration of a single Ziacom Zinic dental implant with internal hexagonal prosthetic connection
Intervention Type
Device
Intervention Name(s)
Ziacom Galaxy dental implant with internal connical prosthetic connection
Intervention Description
Placement and restoration of a single Ziacom Galaxy dental implant with internal connical prosthetic connection
Intervention Type
Device
Intervention Name(s)
Ziacom Zinic dental implant with internal hexagonal prosthetic connection
Intervention Description
Placement and restoration of a single Ziacom Zinic dental implant with internal hexagonal prosthetic connection
Primary Outcome Measure Information:
Title
Marginal bone level
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Peri-implant microbiome
Description
Relative abundance of microbial species in the peri-implant sulcus evaluated by next-generation sequencing methods
Time Frame
1 year
Title
Peri-implant inflammation
Description
Concentration of pro-inflammatory markers in the peri-implant sulcus evaluated by multiplex techniques methods
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal).
Exclusion Criteria:
One-stage bone augmentation.
Uncontrolled type 1 or 2 diabetes (HgA1c>8).
Known auto-immune or inflammatory disease.
Severe hematologic disorders, such as hemophilia or leukemia.
Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology).
Liver or kidney dysfunction/failure.
Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy.
Long-term history of oral bisphosphonates use (i.e., 10 years or more).
History of intravenous bisphosphonates.
Long-term (>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system 3 months before inclusion.
Severe osseous diseases (e.g., Paget disease of bone).
Pregnant women or nursing mothers.
Not able or not willing to follow instructions related to the study procedures.
Facility Information:
Facility Name
Universidad de Granada
City
Granada
ZIP/Postal Code
18071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Padial-Molina, DDS, PhD
Email
mipadial@ugr.es
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34830709
Citation
Galindo-Moreno P, Concha-Jeronimo A, Lopez-Chaichio L, Rodriguez-Alvarez R, Sanchez-Fernandez E, Padial-Molina M. Marginal Bone Loss around Implants with Internal Hexagonal and Internal Conical Connections: A 12-Month Randomized Pilot Study. J Clin Med. 2021 Nov 20;10(22):5427. doi: 10.3390/jcm10225427.
Results Reference
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Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic Connection
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