Fundacion Clinica Pardiñas
A Coruña, Galicia, 15003, Spain
NCT Number: NCT04421066
In this study genomic, proteomic and histological technologies for the search and characterization of epigenetic modifications and molecular or protein markers, useful in the diagnosis and progression of peri-implant diseases and prevention of implant failure will be used.
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Notify Me20 year–90 year
All sexes
Observational
A Coruña, Galicia, 15003, Spain
Samples stored at the Biomedical Research Institute of A Coruña, Xerencia Integrated Management of A Coruña (University Hospital Center of A Coruña), belonging to the collection of the line of research "Oral Health and Systemic Relationship" with registration nº 2017/104 will be used for the realization of the present study.
Nucleic acid extraction and histological analysis of the samples will be performed to evaluate the functional epigenetic modifications associated with peri-implant diseases, in an exploratory manner.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
In addition to the general criteria listed, samples of a healthy periodontal subject must meet the following criteria when reviewing their medical and dental history :
-Subjects do not have or have had a history of periodontal disease, as described in the " 2017 World Workshop on the Classification of Periodontal and Peri- Implant Diseases and Conditions "
Samples from a subject with peri-implant disease must meet the following criteria:
-Samples of subjects who have at least one implant - supported prosthesis for at least 12 months and affected by peri- implant disease according to the " 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions "
Exclusion criteria
Samples of subjects assigned to the healthy group that meet any of the following criteria will be excluded from participation in this study:
Peri- implant disease samples / Exclusion of Subjects
The samples of the subjects assigned to the peri- implant diseases group that meet any of the following criteria will be excluded from participation in this study if the implants were removed due to:
Gingival and bone samples will be collected from the sites affected by peri-implantitis during their surgical treatment of peri-implantitis or histological and epigenetic analysis.
Gingival and bone samples will be collected from the extraction sites for histological and epigenetic analysis.
Time frame: 1 day
Gingival and blood samples collected from healthy subjects and subjects with peri-implantitis (including failing implants) will be used to determinate histological characteristics associated with peri-implantitis.
Time frame: 1 day
Gingival and blood samples collected from healthy subjects and subjects with peri-implantitis (including failing implants) will be used to determinate epigenetic characteristics associated with peri-implantitis.
Time frame: 1 day
To determine whether periodontal measurements PPD (in mm) are associated with epigenetic modifications.
Time frame: 1 day
To determine whether periodontal measurements bleeding on probing (BOP) (measured in percentage), are associated with epigenetic modifications.
Time frame: 1 day
To determine whether periodontal measurements CAL (clinical insertion level in mm), are associated with epigenetic modifications.
Time frame: 1 day
To determine whether periodontal measurements plaque index (Sillness & Loe index)
Time frame: 1 day
To determine whether patient-reported outcome measures (PROMs) are related to histological and epigenetic outcomes.
Oral Health Impact Profile-14 (OHIP-14) assessed at study visit.
Simón Pardiñas López
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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