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| Name | Class |
|---|---|
| NYU Langone Health | OTHER |
| Göteborg University | OTHER |
| University Hospital A Coruña | OTHER |
| Instituto de Investigacion Biomedica de A Coruna |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peri-implantitis | Patients with at least one dental implant diagnosed with peri-implantitis undergoing treatment for peri-implantitis as their standard of care will be included in this study. |
| |
| Healthy | Patients with general good health and health gingiva undergoing extraction of wisdom tooth will be included in this study group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gingival and bone sample collection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in histological characteristics in peri-implantitis subjects compared to healthy subjects, ie, presence and amount of inflammatory cells and bacteria. | 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. | 1 day |
| Differences in epigenetic characteristics analyzing DNA methylation in peri-implantitis subjects compared to healthy subjects. | 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Relation between peri-implant diseases and epigenetic modifications in terms of periodontal pocket depth. | To determine whether periodontal measurements PPD (in mm) are associated with epigenetic modifications. | 1 day |
| Relation between peri-implant diseases and epigenetic modifications in terms of bleeding on probing. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Simón Pardiñas López, DDS, MS | Fundación ClÃnica Pardiñas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion Clinica Pardiñas | A Coruña | Galicia | 15003 | Spain |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D002638 | Chewing Gum |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| OTHER |
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Gingival and bone samples
| Healthy individuals | Procedure | Gingival and bone samples will be collected from the extraction sites for histological and epigenetic analysis. |
|
To determine whether periodontal measurements bleeding on probing (BOP) (measured in percentage), are associated with epigenetic modifications. |
| 1 day |
| Relation between peri-implant diseases and epigenetic modifications in terms of clinical attachment level. | To determine whether periodontal measurements CAL (clinical insertion level in mm), are associated with epigenetic modifications. | 1 day |
| Relation between peri-implant diseases and epigenetic modifications in terms of plaque index. | To determine whether periodontal measurements plaque index (Sillness & Loe index) | 1 day |
| Patient-reported outcome measures. | 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. | 1 day |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |