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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Implant Tissue Failure; Peri-Implantitis; Peri-implant Mucositis; Implant Complication
• Intervention / Treatment: Procedure: Gingival and bone sample collection; Procedure: Healthy individuals

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
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Spain
  • Galicia
    • A Coruña, Galicia, Spain, 15003
      • Fundacion Clinica Pardiñas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• Periodontally Healthy Subjects
• Peri-implantitis Subjects

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
Healthy; Patients with general good health and health gingiva undergoing extraction of wisdom tooth will be included in this study group.	Procedure: Healthy individuals; Gingival and bone samples will be collected from the extraction sites for histological and epigenetic analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Simón Pardiñas López
• Collaborators: Göteborg University; NYU Langone Health; University Hospital A Coruña; Instituto de Investigacion Biomedica de A Coruna
• Investigators: Principal Investigator: Simón Pardiñas López, DDS, MS, Fundacion Clinica Pardiñas

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2019
• Primary Completion (ANTICIPATED): October 21, 2021
• Study Completion (ANTICIPATED): December 20, 2025

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (ACTUAL): June 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Mucositis; Peri-Implantitis
• Other Study ID Numbers: 18-101718

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No