NCT04926519

Brief Summary

The general aim of this project is to get a better understanding how periodontitis develop in young individuals over time and identify factors that contribute to disease recurrence. The investigators also want to see if Stage and Grade of the periodontal disease has a significant impact on disease progression. In addition, another purpose is to identify factors explaining why certain young patients with periodontitis interrupt the periodontal treatment. The specific aims of the project are:

  • To study the periodontal status and the degree of disease progression over 10 years for young individuals with periodontitis at age \< 36 yrs at baseline (study 1)
  • To identify factors with a significant influence on periodontitis progression for young individuals with periodontitis at baseline (study 2)
  • To identify explanatory factors to discontinuation of periodontal treatment (study 3)
  • To identify bio marker and microbiological profiles in young individuals in relation to stage and grade of periodontitis (study 4) Significance: A high patient compliance rate and effective supportive treatment to prevent periodontitis progression are crucial conditions for the long-term prognosis. The identification of factors influencing the compliance rate can improve the frequency of individuals following a supportive care program. In addition, long-time follow-up studies of individuals with the diagnosis severe periodontitis at young age are lacking as well as deeper knowledge concerning risk predictors for further disease progression. The identification of biomarkers or microorganisms that can differentiate between different stage and grade of periodontitis could make it possible to identify individuals with a high risk for disease progression at an early stage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
471

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

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

Study Start

First participant enrolled

October 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2020

Completed
9 months until next milestone

First Posted

Study publicly available on registry

June 15, 2021

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

1.5 years

First QC Date

October 2, 2020

Last Update Submit

September 24, 2025

Conditions

Keywords

severe periodontitislong-term disease progression

Outcome Measures

Primary Outcomes (1)

  • Periodontal disease progression in young individuals with periodontitis 10-13 years after baseline

    Periodontal progression will be assessed by Periodontitis grade according to The 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions: This is a categorical variable consisting of ordinal data at three levels (A, B, C). A is the lowest progression rate and C is the highest rate. The assessment is performed by comparing the degree of periodontal bone loss between baseline and follow-up.

    October 2018 to May 2021

Secondary Outcomes (2)

  • Factors influencing tooth loss over 9 - 11 years in young individuals with periodontitis

    2020 to 2022

  • To identify bio marker and microbiological profiles in young individuals in relation to stage and grade of periodontitis

    2020-2023

Study Arms (2)

Aggressive periodontitis

Patients that got the diagnosis aggressive periodontitis at baseline. Since 2018 we have the classification system with stage and grade why patients get this classification at the clinical examination.

Other: Type of periodontal treatment

Chronic periodontitis

Patients that got the diagnosis chronic periodontitis at baseline. Since 2018 we have the classification system with stage and grade why patients get this classification at the clinical examination.

Other: Type of periodontal treatment

Interventions

Identify factors that contribute to disease recurrence due to periodontal classification and periodontal treatment. One group have got the diagnosis aggressive periodontitis at baseline and the other group chronic periodontitis. Since 2018 we have the classification system with stage and grade.

Aggressive periodontitisChronic periodontitis

Eligibility Criteria

AgeUp to 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients at age \< 36 years who were examined by a periodontist at two specialist clinics in Stockholm during the years 2003-2009 (baseline) and got the diagnoses aggressive or chronic periodontitis were included in the project. Study group: Patients with diagnosis aggressive periodontitis at baseline Control group: Patients with diagnosis chronic periodontitis at baseline

You may qualify if:

  • All patients with diagnoses aggressive or chronic periodontitis

You may not qualify if:

  • Not living in Stockholm County
  • Mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Folktandvården Eastmaninstitutet

Stockholm, 102 31, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial samples from deep periodontal pockets and samples of gingival crevicular fluid from deep periodontal pockets

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Leif Jansson, DDSPhDAssPro

    Folktandvården Stockholm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, Senior Consultant in Periodontology

Study Record Dates

First Submitted

October 2, 2020

First Posted

June 15, 2021

Study Start

October 1, 2018

Primary Completion

March 30, 2020

Study Completion

August 15, 2020

Last Updated

September 29, 2025

Record last verified: 2025-09

Locations