Microbiota Around Periodontal Teeth and Implants Affected by Peri-implant Disease.

NCT03407911 | Completed

• 1 other identifier: Barbagallo Perimplantitis
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study was to evaluate, from a microbiological point of view, microbiota around teeth and implants in the same patient affected by periodontal disease and peri-implant disease, all compared with a healthy tooth. From the identification of particular bacterial species in the examined sites, it is intended to be traced back to the identification of a clear etiopathogenic process, which may shed light on the similarities and differences between the two diseases. In recognition of these mechanisms, the investigators think to develop new therapeutic strategies for the future.

Conditions

Peri-Implantitis; Periodontal Diseases

Keywords

Peri-implant pocket microbiota; Periodontal pocket microbiota

Outcome Measures

Primary Outcomes (1)

• Peri-implant Microbiota

  bacterial population around implant affected by peri-implantitis

  1 day

Secondary Outcomes (1)

• Microbiota in Peri-implantitis and periodontal disease

  1 day

Study Arms (3)

Peri-implant microbiota

Bacterial population in Gingival Intracrevicular fluid harvested with adsorbent paper point

Other: Harvested

Periodontal pocket microbiota

Bacterial population in Gingival Intracrevicular fluid harvested with adsorbent paper point

Other: Harvested

healthy teeth

Bacterial population in Gingival Intracrevicular fluid harvested with adsorbent paper point

Other: Harvested

Interventions

Harvested OTHER

Metagenomic exam of Gingival crevicular fluid harvested by adsorbent paper point around periodontal teeth and implant affected by peri-implantitis

Peri-implant microbiota; Periodontal pocket microbiota; healthy teeth

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People who received at least one implant loaded for at least one year and affected by peri-implantitis and contemporary present a periodontal tooth and a healthy tooth in own mouth

You may qualify if:

• Implant in service for at least one year without any technical GBR.
• Only Implant inserted on native bone
• Fill out a medical history form and a periodontal board dedicated to the event

You may not qualify if:

• Post-extractive implant
• Patients in subintrant systemic conditions that contraindicate the insertion of implants
• Patients in the last three months have taken antibiotics or follow any therapy for the resolution of acute events.
• Women who are pregnant or nursing or undergoing hormone therapies

Sponsors & Collaborators

• Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele: lead

Study Sites (1)

University School of Dental Medicine

Catania, 95100, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

gingival crevicular fluid around teeth affected by periodontal disease and implant affected by peri-implant disease. samples obtained by inserting paper cone in periodontal and peri-implant sulcus.

MeSH Terms

Conditions

Peri-Implantitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Sebastiano Ferlito

  Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 23, 2018
• Study Start: February 1, 2018
• Primary Completion: April 1, 2018
• Study Completion: June 1, 2018
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: starting one month after publication
• Access Criteria: Sending an e mail with specific request

Locations

IT (1)