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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05859113
Other study ID # 2978/CEIH/2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 10, 2023
Est. completion date June 30, 2025

Study information

Verified date July 2023
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date June 30, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ziacom Galaxy dental implant with internal connical prosthetic connection
Placement and restoration of a single Ziacom Galaxy dental implant with internal connical prosthetic connection
Ziacom Zinic dental implant with internal hexagonal prosthetic connection
Placement and restoration of a single Ziacom Zinic dental implant with internal hexagonal prosthetic connection

Locations

Country Name City State
Spain Universidad de Granada Granada

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Marginal bone level 1 year
Secondary Peri-implant microbiome Relative abundance of microbial species in the peri-implant sulcus evaluated by next-generation sequencing methods 1 year
Secondary Peri-implant inflammation Concentration of pro-inflammatory markers in the peri-implant sulcus evaluated by multiplex techniques methods 1 year
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