Histological, Genetic and Epigenetic Analysis of Procedures Related with Dental Implants
1 other identifier
observational
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 29, 2019
CompletedFirst Submitted
Initial submission to the registry
June 1, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2022
CompletedFebruary 26, 2025
February 1, 2025
2.7 years
June 1, 2020
February 24, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (5)
Relation between peri-implant diseases and epigenetic modifications in terms of periodontal pocket depth.
1 day
Relation between peri-implant diseases and epigenetic modifications in terms of bleeding on probing.
1 day
Relation between peri-implant diseases and epigenetic modifications in terms of clinical attachment level.
1 day
Relation between peri-implant diseases and epigenetic modifications in terms of plaque index.
1 day
Patient-reported outcome measures.
1 day
Study Arms (2)
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.
Interventions
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.
Eligibility Criteria
* Periodontally Healthy Subjects * Peri-implantitis Subjects
You may qualify if:
- The subjects must have read, understood and signed an informed consent regarding the obtaining of biological samples and participation in the research line of "Oral Health and Systemic Relationship" existing in the Pardiñas Dental Medical Clinic and approved by the ethical committee.
- The subjects must be between 20-90 years of age.
- Subjects must be non-smokers or former smokers who have quit smoking for at least one year prior to enrollment in the study.
- 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 "
You may not qualify if:
- Samples of pregnant or lactating women at the time of collection.
- Samples of subjects who were taking antibiotics within 1 month before collection of the sample.
- Samples of subjects with chronic use of non-steroidal anti-inflammatory drugs for more than 3 weeks at the time of sample collection. The use of aspirin in low doses (≤81 mg / day) will be allowed .
- Samples from subjects with disease in the mucosa in the area located around the site of sample collection.
- Samples of subjects with a systemic disease that would exclude the analysis (for example, severe medical problems, bone metabolism disorders, uncontrolled bleeding disorders, depressed immune system, diseases that require the periodic use of steroids, uncontrolled endocrine disorders) .
- Samples of subjects with a history of local irradiation therapy in the head / neck area.
- Samples of subjects with a history of having received treatment with intravenous or subcutaneous antiresorptive agents associated with osteonecrosis of the jaw, such as bisphosphonates.
- Samples of subjects assigned to the healthy group that meet any of the following criteria will be excluded from participation in this study:
- Root fragments, pericoronaritis, endo-perio lesions, dental abscesses at the site of the biopsy.
- Presence of BOP in the sample collection site.
- 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:
- Inadequate position of the implant.
- Subjects with implants previously treated surgically for peri- implant disease with antibiotics.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Simón Pardiñas Lópezlead
- NYU Langone Healthcollaborator
- Göteborg Universitycollaborator
- University Hospital A Coruñacollaborator
- Instituto de Investigacion Biomedica de A Corunacollaborator
Study Sites (1)
Fundacion Clinica Pardiñas
A Coruña, Galicia, 15003, Spain
Biospecimen
Gingival and bone samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simón Pardiñas López, DDS, MS
Fundación Clínica Pardiñas
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
June 1, 2020
First Posted
June 9, 2020
Study Start
January 29, 2019
Primary Completion
October 21, 2021
Study Completion
June 20, 2022
Last Updated
February 26, 2025
Record last verified: 2025-02