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PeriodontitisNCT04926519

Periodontitis in Young Individuals, Follow up of Treatment and Disease Progression Over 10 Years

An observational study of Periodontitis, run by Folktandvården Stockholms län AB at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 35 years
Conditions the study is for
Periodontitis
What is being tested?
Type of periodontal treatment
How many people
471 participants
Where
1 siteSweden
Study dates
1 Oct 2018to 15 Aug 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

  • All patients with diagnoses aggressive or chronic periodontitis

Who cannot join

  • Not living in Stockholm County
  • Mental illness.

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Folktandvården Eastmaninstitutet

    Stockholm, 102 31

Other trials in Sweden

About this study

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:

Read more
  • 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.

Read the detailed description

Data collection:

All patients at age <36 years who were examined by a periodontist at 2 specialist clinics in Periodontology (Folktandvården Stockholm) during the years 2003-2009 with the diagnoses aggressive or chronic periodontitis are included in the project. The material consists of 471 patients. All participants are invited by mail to a clinical and radiographic examination. The clinical examination includes periodontal status and microbiological sampling and samples of crevicular fluid from deepened periodontal pockets >6. At time of examination the participants also fill in an questionnaire regarding oral hygiene habits, socio-economic factors and self-percieved oral health. Baseline information is collected from dental records.

Studies 1 and 2:

Title study 1: Periodontal status and disease progression after 10 years in young individuals with periodontitis. A follow-up study.

Title study 2: Risk predictors for periodontitis progression in young individuals with periodontitis.

Study variables:

The following variables were registered from dental records:

Diagnoses: Aggressive or chronic periodontitis, local or general periodontitis, age at baseline, sex, smoking habits at baseline, number of remaining teeth, general degree of marginal bone, presence of angular bony defects , bleeding index, periodontal pocket depths at four sites/tooth, presence of furcation involvements, mobility (degree 0-3), periodontal treatment after baseline investigation (non-surgical treatment, surgical treatment, antibiotic treatment, supportive care, treatment interrupted)

The following variables will be registered at the clinical investigation:

Number of years since baseline, number of remaining teeth, general degree of marginal bone loss, presence of angular bony defects, bleeding index, periodontal pocket depths at four sites/tooth, presence of furcation involvements, mobility (degree 0-3), microbiological test if minimum of one site bleeding on probing with periodontal pocket depth >6mm, Samples of crevicular fluid from deepened periodontal pockets >6, saliva specimens, stimulated saliva collected for two minutes

Radiografic examination: panorama x-rays and six IO x-rays

The diagnosis at baseline (chronic or aggressive periodontitis) will be transformed to the new periodontal classification system.

The following variables will be registered from a questionnaire at the clinical investigation:

Smoking habits, general health, socio-economic variables, frequency of dental visits during the follow-up period, frequency of supportive care during the follow-up period, oral hygiene habits, subjective symptoms from the mouth

Study 3:

Title: A retrospective follow-up over 10 years of dental care for young individuals with periodontitis

Study variables:

The following variables were registered from the dental records at baseline and the following treatment periods:

Year of baseline investigation, age, sex, smoking habits, general health, number of teeth at baseline, periodontal pocket depths at baseline, bleeding on probing score at baseline, tooth mobility at baseline, presence of furcation involvement at baseline, presence of angular bony defects at baseline, periodontal diagnosis, number of dental visits, treatment interrupted, number of teeth at re-evaluation, periodontal pocket depths at re-evaluation, bleeding on probing score at re-evaluation, year of the last re-evaluation.

The diagnosis at baseline (chronic or aggressive periodontitis) will be transformed to the new classification system.

The following variables will be registered from Tandhälsoregistret (register of dental health) at the National Board of Health and Welfare:

Age at dental visits, years of dental visits, country of birth, number of teeth, citizenship, date of migration, public/private dental care, marital status, kind of dental treatment, dental diagnosis, tooth number, tooth position.

Study 4:

Title: Bio marker and microbiological profiles in young individuals in relation to stage and grade of periodontitis.

Data collection: Saliva specimens are obtained by collecting unstimulated saliva for two minutes and stored at -70 degrees C until analyses. The levels of cytokines and bone resorption markers in the saliva samples will be analyzed using the Luminex technology on a Bioplex Suspension Array System (Bio-Rad Laboratories), Milliplex MAP bone metabolism kits (Millipore) or Fluorokine MAP Multiplex MMP (R\&D Systems). Bacterial samples will be collected from the periodontal pockets with sterile paper points. The microbiological analyses will be performed using DNA extraction with 16S rRNA Sequencing.

Study variables:

The following cytokines will be analyzed: G-CSF, GM-CSF, IFN-gamma, IL1-β, IL-4, IL-6, IL-7, IL-8, IL-10, IL-12p70, IL-13, IL-15, IL-18, M-CSF, MIP-1α, MIP-1β, RANTES, eotaxin TNF-alfa, MCP-1, The following bone resorption markers will be analyzed: RANKL, OPG, Osteopontin, Osteocalcin, MMP-8 and MMP-9, Salivary flow, Distribution of microbiota

Conditions
Periodontitis
Being tested
Type of periodontal treatment
Keywords
severe periodontitis, long-term disease progression
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Type of periodontal treatmentOther

    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.

Study groups in NCT04926519
Study groupRoleWhat they receive
Aggressive periodontitisPatients 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.
Receives: Other: Type of periodontal treatment
Chronic periodontitisPatients 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.
Receives: Other: Type of periodontal treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: October 2018 to May 2021

Secondary outcomes (2)
  1. Factors influencing tooth loss over 9 - 11 years in young individuals with periodontitis

    The primary outcome variable was the number of teeth lost due to periodontitis during the follow-up period (2009-2019).

    Variables were collected from digital dental records combined with two national health registers; Swedish Dental Health register and Statistics Sweden Baseline clinical periodontal variables and information about interruption of APT at the specialist clinic (secondary outcome variable) were collected from dental records at periodontal clinics between 2003-2010.

    Measured: 2020 to 2022

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

    Cytokine- and bone resorption markers:

    This is a continuous variable and the levels in the crevicular fluid are expressed as pg/ml.

    Microbiological analyses:

    We will analyse number of bacteria. Comparing healthy sites with diseased ones. This method will give us information if any of the analysed bacteria are overrepresented

    Measured: 2020-2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2021
  2. Study start1 Oct 2018
  3. Primary completion30 Mar 2020
  4. Study completion15 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
471 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04926519
Sponsor's protocol ID
556574-3597
Status last verified
Sep 2025
First submitted
2 Oct 2020
Last updated
29 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontitis, run by Folktandvården Stockholms län AB at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Periodontal disease progression in young individuals with periodontitis 10-13 years after baseline (time frame: October 2018 to May 2021). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.

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