Peri-ImplantitisNCT04421066
Histological, Genetic and Epigenetic Analysis of Procedures Related with Dental Implants
An observational study of Peri-Implantitis and Peri-implant Mucositis, run by Simón Pardiñas López at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Peri-implant Mucositis, Implant Complication
- What is being tested?
- Gingival and bone sample collection and Healthy individuals
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 29 Jan 2019to 20 Jun 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Periodontally Healthy Subjects * Peri-implantitis Subjects
Who may be able to join
- 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 "
Who cannot join
- 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.
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- 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.
- 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:
- Inadequate position of the implant.
- Subjects with implants previously treated surgically for peri- implant disease with antibiotics.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- Gingival and bone sample collection, Healthy individuals
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival and bone sample collectionProcedure or surgery
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.
Healthy individualsProcedure or surgery
Gingival and bone samples will be collected from the extraction sites for histological and epigenetic analysis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Gingival and bone sample collection | |
| Healthy | Patients with general good health and health gingiva undergoing extraction of wisdom tooth will be included in this study group. Receives: Procedure: Healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day
Secondary outcomes (5)
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.
Measured: 1 day
Relation between peri-implant diseases and epigenetic modifications in terms of bleeding on probing.
To determine whether periodontal measurements bleeding on probing (BOP) (measured in percentage), are associated with epigenetic modifications.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start29 Jan 2019
- Primary completion21 Oct 2021
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Simón Pardiñas López
- Sponsor type
- University, hospital or other
- Collaborators
- NYU Langone Health, Göteborg University, University Hospital A Coruña, Instituto de Investigacion Biomedica de A Coruna
- Responsible party
- Sponsor-investigator, Simón Pardiñas López, Fundacion Clinica Pardinas
- Investigators
- Simón Pardiñas López, DDS, MS, Principal investigator, Fundación Clínica Pardiñas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421066
- Sponsor's protocol ID
- 18-101718
- Status last verified
- Feb 2025
- First submitted
- 1 Jun 2020
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological, Genetic and Epigenetic Analysis of Procedures Related with Dental Implants
- ClinicalTrials.gov ID
- NCT04421066
- Acronym / sponsor ID
- 18-101718
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Simón Pardiñas LópezUniversity, hospital or other
- Collaborators
- NYU Langone Health, Göteborg University, University Hospital A Coruña, Instituto de Investigacion Biomedica de A Coruna
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peri-implantitis | – | Procedure: Gingival and bone sample collectionPatients 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 | – | Procedure: Healthy individualsPatients with general good health and health gingiva undergoing extraction of wisdom tooth will be included in this study group. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Periodontally Healthy Subjects * Peri-implantitis Subjects
Key inclusion criteria (7 listed)
- 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 "
Key exclusion criteria (14 listed)
- 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) .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gingival and bone sample collectionGingival 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. | Procedure or surgery | Peri-implantitis |
| Healthy individualsGingival and bone samples will be collected from the extraction sites for histological and epigenetic analysis. | Procedure or surgery | Healthy |
Primary outcome
Differences in histological characteristics in peri-implantitis subjects compared to healthy subjects, ie, presence and amount of inflammatory cells and bacteria.
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.
Differences in epigenetic characteristics analyzing DNA methylation in peri-implantitis subjects compared to healthy subjects.
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.
5 secondary outcomes
Relation between peri-implant diseases and epigenetic modifications in terms of periodontal pocket depth.
Time frame: 1 day
Relation between peri-implant diseases and epigenetic modifications in terms of bleeding on probing.
Time frame: 1 day
Relation between peri-implant diseases and epigenetic modifications in terms of clinical attachment level.
Time frame: 1 day
Relation between peri-implant diseases and epigenetic modifications in terms of plaque index.
Time frame: 1 day
Patient-reported outcome measures.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simón Pardiñas López, DDS, MS principal investigator
Fundación Clínica Pardiñas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-Implantitis and Peri-implant Mucositis, run by Simón Pardiñas López at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in histological characteristics in peri-implantitis subjects compared to healthy subjects, ie, presence and amount of inflammatory cells and bacteria. (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.