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

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04421066
• Other study ID #: 18-101718
• Status: Active, not recruiting
• Start date: January 29, 2019
• Est. completion date: December 20, 2025

Study information

• Verified date: August 2021
• Source: Fundacion Clinica Pardinas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 20, 2025
• Est. primary completion date: October 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Implant Complication
• Implant Tissue Failure
• Mucositis
• Peri-implant Mucositis
• Peri-Implantitis

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.
• Healthy individuals
Gingival and bone samples will be collected from the extraction sites for histological and epigenetic analysis.

Locations

Country	Name	City	State
Spain	Fundacion Clinica Pardiñas	A Coruña	Galicia

Sponsors (5)

Lead Sponsor	Collaborator
Simón Pardiñas López	Göteborg University, Instituto de Investigacion Biomedica de A Coruna, NYU Langone Health, University Hospital A Coruña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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