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.
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.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Type of periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted15 Jun 2021
- Study start1 Oct 2018
- Primary completion30 Mar 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Folktandvården Stockholms län AB
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Carolina Modin, Folktandvården Stockholms län AB
- Investigators
- Leif Jansson, DDSPhDAssPro, Principal investigator, Folktandvården Stockholm
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontitis in Young Individuals, Follow up of Treatment and Disease Progression Over 10 Years
- ClinicalTrials.gov ID
- NCT04926519
- Acronym / sponsor ID
- 556574-3597
- Conditions
- Periodontitis
- Keywords
- severe periodontitis, long-term disease progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Folktandvården Stockholms län ABOther government
- Collaborators
- Karolinska Institutet
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aggressive periodontitis | – | Other: Type of periodontal treatmentPatients 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. |
| Chronic periodontitis | – | Other: Type of periodontal treatmentPatients 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. |
Who may qualify
- Ages
- Up to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- All patients with diagnoses aggressive or chronic periodontitis
Key exclusion criteria (2 listed)
- Not living in Stockholm County
- Mental illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Type of periodontal treatmentIdentify 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. | Other | Aggressive periodontitis, Chronic periodontitis |
Primary outcome
Periodontal disease progression in young individuals with periodontitis 10-13 years after baseline
Time frame: October 2018 to May 2021
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.
2 secondary outcomes
Factors influencing tooth loss over 9 - 11 years in young individuals with periodontitis
Time frame: 2020 to 2022
To identify bio marker and microbiological profiles in young individuals in relation to stage and grade of periodontitis
Time frame: 2020-2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leif Jansson, DDSPhDAssPro principal investigator
Folktandvården Stockholm
1 site in 1 country: see every site and its status.
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.