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Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic Connection

NCT ID: NCT05859113

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Jaw, Edentulous, Partially

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ziacom Galaxy dental implant with internal connical prosthetic connection

Placement and restoration of a single Ziacom Galaxy dental implant with internal connical prosthetic connection

Group Type EXPERIMENTAL

Ziacom Galaxy dental implant with internal connical prosthetic connection

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

Ziacom Zinic dental implant with internal hexagonal prosthetic connection

Intervention Type DEVICE

Placement and restoration of a single Ziacom Zinic dental implant with internal hexagonal prosthetic connection

Interventions

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Ziacom Galaxy dental implant with internal connical prosthetic connection

Placement and restoration of a single Ziacom Galaxy dental implant with internal connical prosthetic connection

Intervention Type DEVICE

Ziacom Zinic dental implant with internal hexagonal prosthetic connection

Placement and restoration of a single Ziacom Zinic dental implant with internal hexagonal prosthetic connection

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Miguel Padial-Molina

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad de Granada

Granada, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Miguel Padial-Molina, DDS, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 34830709 (View on PubMed)

Other Identifiers

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2978/CEIH/2022

Identifier Type: -

Identifier Source: org_study_id