NCT01246596

Brief Summary

The etiopathogenesis of periodontal disease results from complex interaction between infectious agents, mainly including bacteria, and host cellular and humoral immune responses. However it is thought that bacteria-induced pathogenesis is not sufficient alone to explain all biological and clinical features of the destructive periodontal disease. The main hypothesis is that herpesviruses, such as Epstein-Barr Virus, may participate as well by altering epithelial gingival cell biology and consequently may promote the initiation and progression of periodontitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2014

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

3.3 years

First QC Date

November 17, 2010

Last Update Submit

November 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of gingival epithelial cells infected by EBV (by immunofluorescence and In situ Hybridization)

    at time=0

Secondary Outcomes (2)

  • Epithelial tissue infected by EBV (by immunofluorescence and in situ hybridization)

    at time = 0

  • Presence / absence of latency and / or lytic proteins (by immunofluorescence and in situ hybridization)

    at time = 0

Study Arms (3)

chronic periodontitis

ACTIVE COMPARATOR
Procedure: dental root planing

aggressive periodontitis

ACTIVE COMPARATOR
Procedure: dental root planing

healthy patient (orthodontics extraction)

ACTIVE COMPARATOR
Procedure: dental root planing

Interventions

The objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus,\[1\] thus helping to establish a periodontium that is free of disease.\[2\]

chronic periodontitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients affected by chronic periodontitis
  • patients affected by aggressive periodontitis
  • healthy patients (orthodontics extraction)
  • Subject who have read and understood the information note relative under investigation and who have signed the informed consent
  • major patient

You may not qualify if:

  • Patient with no contre-indication to periodontal treatment
  • Patient with serious blood disease
  • Patient who exhibits systemic condition incompatible with realization of the study
  • Patient treated with oral retinoids, bisphosphonates, oral anticoagulants and anticonvulsivants
  • Patient who presents a buccal carcinoma treated with radiotherapy
  • Patient who have received during the past 6 months: anti-inflammatory drugs, anti-cancerous or immunosuppressive chemiotherapy
  • Patient who presents a linguistic or psychic incapacity to understand information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Severine VINCENT

Nice, 0600, France

Location

MeSH Terms

Conditions

Chronic PeriodontitisAggressive Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Severine VINCENT, PH

    CHU de Nice Hôpital Saint Roch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2010

First Posted

November 23, 2010

Study Start

January 1, 2011

Primary Completion

May 5, 2014

Study Completion

May 5, 2014

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations