PeriodontitisNCT02913248
Salivary Bacterial Profiles in Relation to Periodontal Treatment
A study testing Conventional periodontal treatment in people with Periodontitis, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of the present investigation is to record and compare bacterial compositions in subgingival plaque samples and saliva samples in subjects receiving periodontal treatment. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Conventional periodontal treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2016to 2 Jan 2017
- Phase
- Interventional
- 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 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Manifest chronic periodontitis according to international classification
Who cannot join
- Other treatment requiring oral conditions
- Systemic antibiotics within the latest 6 months
- Systemic diseases and medications with known associations to periodontitis
- Pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Copenhagen, Department of Odontology
Copenhagen, Copenhagen, 2200
About this study
Official title: Short and Long Term Alterations of Subgingival and Salivary Microbiota in Relation to Periodontal Treatment
The purpose of the present investigation is to record and compare bacterial compositions in subgingival plaque samples and saliva samples in subjects receiving periodontal treatment. The hypothesis is that the composition of the salivary microbiota might reflect local bacterial alterations in relation to periodontal treatment.
Read the detailed description
In this study we plan to enroll 35 subjects with manifest periodontitis, which will be treated according to national and international guidelines. Clinical registration and collection of subgingival plaque samples and saliva samples will be performed at baseline and 2, 6 and 12 weeks after treatment.
- Conditions
- Periodontitis
- Being tested
- Conventional periodontal treatment
- Keywords
- periodontitis, saliva, bacteria
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional periodontal treatmentProcedure or surgery
Non-surgical periodontal treatment including thorough instruction in self-performed oral hygiene
| Study group | Role | What they receive |
|---|---|---|
| Conventional periodontal treatment | Experimental | 35 subjects diagnosed with manifest periodontitis, which will all receive standardized treatment according to protocol. In brief, this treatment includes professional tooth cleaning and thorough instruction in self-performed oral hygiene procedures. Clinical registrations and collection of microbiological samples (subgingival and saliva) will performed at baseline and 2, 6 and 12 weeks after treatment. Receives: Procedure: Conventional periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in α-diversity in saliva samples collected .
Comparison of α-diversity in saliva samples collected before periodontal treatment and 12 weeks after treatment
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Specis specific changes in saliva samples collected
Comparison of relative abundance of bacterial species in saliva samples collected before periodontal treatment to samples collected 12 weeks after treatment
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startOct 2016
- Primary completion2 Jan 2017
- Study completion2 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Forsyth Institute, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Daniel Belstrøm, DDS, PhD, University of Copenhagen
- Investigators
- Daniel Belstrøm, DDS, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913248
- Sponsor's protocol ID
- UCPH_OI_001
- Status last verified
- Feb 2017
- First submitted
- 20 Sep 2016
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All individual participant data will be handled anonymously
Publications
Grande MA, Belstrom D, Damgaard C, Holmstrup P, Thangaraj SS, Nielsen CH, Palarasah Y. Complement split product C3c in saliva as biomarker for periodontitis and response to periodontal treatment. J Periodontal Res. 2021 Jan;56(1):27-33. doi: 10.1111/jre.12788. Epub 2020 Jul 18.
PubMed 32681659Grande MA, Belstrom D, Damgaard C, Holmstrup P, Kononen E, Gursoy M, Gursoy UK. Salivary concentrations of macrophage activation-related chemokines are influenced by non-surgical periodontal treatment: a 12-week follow-up study. J Oral Microbiol. 2019 Dec 9;12(1):1694383. doi: 10.1080/20002297.2019.1694383. eCollection 2020.
PubMed 31893018
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long Term Alterations of Subgingival and Salivary Microbiota in Relation to Periodontal Treatment
- ClinicalTrials.gov ID
- NCT02913248
- Acronym / sponsor ID
- UCPH_OI_001
- Conditions
- Periodontitis
- Keywords
- periodontitis, saliva, bacteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- The Forsyth Institute, Copenhagen University Hospital, Rigshospitalet
- Study start
- Oct 2016
- Primary completion
- 2 Jan 2017 (actual)
- Study completion
- 2 Jan 2017 (actual)
- First posted
- 23 Sep 2016 (estimated)
- 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 purpose of the present investigation is to record and compare bacterial compositions in subgingival plaque samples and saliva samples in subjects receiving periodontal treatment. The hypothesis is that the composition of the salivary microbiota might reflect local bacterial alterations in relation to periodontal treatment.
Detailed description
In this study we plan to enroll 35 subjects with manifest periodontitis, which will be treated according to national and international guidelines. Clinical registration and collection of subgingival plaque samples and saliva samples will be performed at baseline and 2, 6 and 12 weeks after treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conventional periodontal treatment | Experimental | Procedure: Conventional periodontal treatment35 subjects diagnosed with manifest periodontitis, which will all receive standardized treatment according to protocol. In brief, this treatment includes professional tooth cleaning and thorough instruction in self-performed oral hygiene procedures. Clinical registrations and collection of microbiological samples (subgingival and saliva) will performed at baseline and 2, 6 and 12 weeks after treatment. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Manifest chronic periodontitis according to international classification
Key exclusion criteria (4 listed)
- Other treatment requiring oral conditions
- Systemic antibiotics within the latest 6 months
- Systemic diseases and medications with known associations to periodontitis
- Pregnancy and breastfeeding
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 |
|---|---|---|
| Conventional periodontal treatmentNon-surgical periodontal treatment including thorough instruction in self-performed oral hygiene | Procedure or surgery | Conventional periodontal treatment |
Primary outcome
Changes in α-diversity in saliva samples collected .
Time frame: Baseline and 12 weeks
Comparison of α-diversity in saliva samples collected before periodontal treatment and 12 weeks after treatment
1 secondary outcome
Specis specific changes in saliva samples collected
Time frame: Baseline and 12 weeks
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 3 Feb 2017.
- Derived from this study: PubMed 32681659Grande MA, Belstrom D, Damgaard C, Holmstrup P, Thangaraj SS, Nielsen CH, Palarasah Y. Complement split product C3c in saliva as biomarker for periodontitis and response to periodontal treatment. J Periodontal Res. 2021 Jan;56(1):27-33. doi: 10.1111/jre.12788. Epub 2020 Jul 18.
- Derived from this study: PubMed 31893018Grande MA, Belstrom D, Damgaard C, Holmstrup P, Kononen E, Gursoy M, Gursoy UK. Salivary concentrations of macrophage activation-related chemokines are influenced by non-surgical periodontal treatment: a 12-week follow-up study. J Oral Microbiol. 2019 Dec 9;12(1):1694383. doi: 10.1080/20002297.2019.1694383. eCollection 2020.
- Individual participant dataSharing planned: Yes. All individual participant data will be handled anonymously
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
Daniel Belstrøm, DDS, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional periodontal treatment in people with Periodontitis, run by University of Copenhagen at 1 site in Denmark.
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 4 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 3 Feb 2017. 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 Denmark. 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?
Changes in α-diversity in saliva samples collected . (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02913248, which also lists 2 linked publications.
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 3 Feb 2017.