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Histological, Genetic and Epigenetic Analysis of Procedures Related With Dental Implants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04421066
Recruitment Status : Active, not recruiting
First Posted : June 9, 2020
Last Update Posted : August 19, 2021
Sponsor:
Collaborators:
NYU Langone Health
Göteborg University
University Hospital A Coruña
Instituto de Investigacion Biomedica de A Coruna
Information provided by (Responsible Party):
Simón Pardiñas López, Fundacion Clinica Pardinas

Tracking Information
First Submitted Date June 1, 2020
First Posted Date June 9, 2020
Last Update Posted Date August 19, 2021
Actual Study Start Date January 29, 2019
Estimated Primary Completion Date October 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2020)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 4, 2020)
  • Relation between peri-implant diseases and epigenetic modifications in terms of periodontal pocket depth. [ Time Frame: 1 day ]
    To determine whether periodontal measurements PPD (in mm) are associated with epigenetic modifications.
  • Relation between peri-implant diseases and epigenetic modifications in terms of bleeding on probing. [ Time Frame: 1 day ]
    To determine whether periodontal measurements bleeding on probing (BOP) (measured in percentage), are associated with epigenetic modifications.
  • Relation between peri-implant diseases and epigenetic modifications in terms of clinical attachment level. [ Time Frame: 1 day ]
    To determine whether periodontal measurements CAL (clinical insertion level in mm), are associated with epigenetic modifications.
  • Relation between peri-implant diseases and epigenetic modifications in terms of plaque index. [ Time Frame: 1 day ]
    To determine whether periodontal measurements plaque index (Sillness & Loe index)
  • Patient-reported outcome measures. [ 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Histological, Genetic and Epigenetic Analysis of Procedures Related With Dental Implants
Official Title Histological, Genetic and Epigenetic Analysis of Procedures Related With Dental Implants
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.
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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration 3 Months
Biospecimen Retention:   Samples With DNA
Description:
Gingival and bone samples
Sampling Method Non-Probability Sample
Study Population
  • Periodontally Healthy Subjects
  • Peri-implantitis Subjects
Condition
  • Peri-Implantitis
  • Peri-implant Mucositis
  • Implant Complication
  • Implant Tissue Failure
Intervention
  • Procedure: Gingival and bone sample collection
    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.
  • Procedure: Healthy individuals
    Gingival and bone samples will be collected from the extraction sites for histological and epigenetic analysis.
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Procedure: Healthy individuals
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 4, 2020)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 20, 2025
Estimated Primary Completion Date October 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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 "

Exclusion Criteria:

  • 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.

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04421066
Other Study ID Numbers 18-101718
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Simón Pardiñas López, Fundacion Clinica Pardinas
Original Responsible Party Same as current
Current Study Sponsor Simón Pardiñas López
Original Study Sponsor Same as current
Collaborators
  • NYU Langone Health
  • Göteborg University
  • University Hospital A Coruña
  • Instituto de Investigacion Biomedica de A Coruna
Investigators
Principal Investigator: Simón Pardiñas López, DDS, MS Fundación Clínica Pardiñas
PRS Account Fundacion Clinica Pardinas
Verification Date August 2021