Peri-implantitisNCT06262035
Transcriptome, Proteome and Microbiome Profile in Periodontal and Peri-implant Diseases
An observational study of Peri-implantitis and Periodontitis, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
1. To investigate the transcriptomic profile of periodontitis and peri-implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included to investigate the gene expression profile in tissue affected by periodontitis and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-implantitis, Periodontitis
- What is being tested?
- Periodontitis and Peri-implantitis
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jun 2024to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with periodontitis and peri-implantitis, referred from a general clinic in Stockholm County to a periodontist.
Who may be able to join
- ≥18 years of age Defined periodontitis at two non-adjacent teeth Defined peri-implantitis at ≥1 implant Signed informed consent
Who cannot join
- Surgical intervention of periodontitis and/or peri-implantitis during last 6 months.
- Local or systemic use of antibiotics during last 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Aqua Dental Specialistklinik
Stockholm
Nilminie Rathnayake, Dr
About this study
- To investigate the transcriptomic profile of periodontitis and peri-implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included to investigate the gene expression profile in tissue affected by periodontitis and peri-implantitis. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and the number of teeth. During surgical intervention, tissue biopsies (two specimens per site) will be collected by a periodontist from site with ongoing periodontitis and site from ongoing peri-implantitis.
- To study the microbiome and biomarker profile associated with periodontitis and peri- implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included in this study to determine the bacteria composition, cytokine profile and inflammatory biomarkers profile. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and number of teeth. Peri-implant crevicular fluid (PICF), gingival crevicular fluid (GCF), saliva and submucosal/subgingival plaque will be collected.The presence and composition of periodontal and peri-implant plaque samples are investigated.
- Conditions
- Peri-implantitis, Periodontitis
- Being tested
- Periodontitis and Peri-implantitis
- Keywords
- Peri-implantitis, Periodontitis
- Medical subject headings
- Peri-Implantitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontitis and Peri-implantitisOther
Defined periodontitis at ≤ 2 non-adjacent teeth AND Defined peri-implantitis at ≤ 1 implant, in function of at least 1 year.
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein levels in peri-implantitis and periodontitis
To measure protein levels in gingival crevicular fluid and in peri-implant crevicular fluid.
Measured: Through study completion, an average of 1 years
Microbiome composition in peri-implantitis and periodontitis using 16S-rRNA sequencing method.
The microbiome composition will be analyzed in samples of subgingival/submucosal plaque using 16S-rRNA sequencing method.
Measured: Through study completion, an average of 1 years
Gene expression profile in peri-implantitis and periodontitis.
Soft tissue specimens will be studied in regards of gene expression levels using RNA sequencing method (Ilumina). The mRNA expression of candidate genes will be studied at protein level using immunohistochemistry.
Measured: Through study completion, an average of 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start15 Jun 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tülay Yucel Lindberg, Karolinska Institutet
- Investigators
- Tülay Lindberg, Ass.prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262035
- Sponsor's protocol ID
- 2023-02987-01
- Other IDs
- 2023
- Status last verified
- Oct 2024
- First submitted
- 25 Jan 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptome, Proteome and Microbiome Profile in Periodontal and Peri-implant Diseases
- ClinicalTrials.gov ID
- NCT06262035
- Acronym / sponsor ID
- 2023-02987-01
- Conditions
- Peri-implantitis, Periodontitis
- Keywords
- Peri-implantitis, Periodontitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 15 Feb 2024 (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.
- To investigate the transcriptomic profile of periodontitis and peri-implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included to investigate the gene expression profile in tissue affected by periodontitis and peri-implantitis. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and the number of teeth. During surgical intervention, tissue biopsies (two specimens per site) will be collected by a periodontist from site with ongoing periodontitis and site from ongoing peri-implantitis.
- To study the microbiome and biomarker profile associated with periodontitis and peri- implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included in this study to determine the bacteria composition, cytokine profile and inflammatory biomarkers profile. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and number of teeth. Peri-implant crevicular fluid (PICF), gingival crevicular fluid (GCF), saliva and submucosal/subgingival plaque will be collected.The presence and composition of periodontal and peri-implant plaque samples are investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with periodontitis and peri-implantitis, referred from a general clinic in Stockholm County to a periodontist.
Key inclusion criteria (1 listed)
- ≥18 years of age Defined periodontitis at two non-adjacent teeth Defined peri-implantitis at ≥1 implant Signed informed consent
Key exclusion criteria (2 listed)
- Surgical intervention of periodontitis and/or peri-implantitis during last 6 months.
- Local or systemic use of antibiotics during last 6 months.
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 |
|---|---|---|
| Periodontitis and Peri-implantitisDefined periodontitis at ≤ 2 non-adjacent teeth AND Defined peri-implantitis at ≤ 1 implant, in function of at least 1 year. | Other | – |
Primary outcome
Protein levels in peri-implantitis and periodontitis
Time frame: Through study completion, an average of 1 years
To measure protein levels in gingival crevicular fluid and in peri-implant crevicular fluid.
Microbiome composition in peri-implantitis and periodontitis using 16S-rRNA sequencing method.
Time frame: Through study completion, an average of 1 years
The microbiome composition will be analyzed in samples of subgingival/submucosal plaque using 16S-rRNA sequencing method.
Gene expression profile in peri-implantitis and periodontitis.
Time frame: Through study completion, an average of 1 years
Soft tissue specimens will be studied in regards of gene expression levels using RNA sequencing method (Ilumina). The mRNA expression of candidate genes will be studied at protein level using immunohistochemistry.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Tülay Lindberg, Ass.prof principal investigator
Karolinska Institutet
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 Peri-implantitis and Periodontitis, run by Karolinska Institutet 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: looking for participants now, as of the sponsor's last update on 10 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carl Titusson, DDS, MSc (+4685088126, carl.titusson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein levels in peri-implantitis and periodontitis (time frame: Through study completion, an average of 1 years). The study lists 3 primary outcomes in all. 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 10 Oct 2024.