Chronic PeriodontitisNCT02159781
Effect of Periodontal Treatment on Salivary Biomarkers
A study testing periodontal treatment - scaling and root planning in people with Chronic Periodontitis, run by The Baruch Padeh Medical Center, Poriya.
Trial summary
The investigators plan to recruit 40 healthy patients referred to the unit of Periodontology, diagnosed with generalized moderate - severe chronic periodontitis. treatment will include 4 - 6 sessions of scaling + root planning, oral hygiene instructions and motivation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- periodontal treatment - scaling and root planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Sep 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy patients
- moderate - sever chronic periodontitis
Who cannot join
- systemic disease
- pregnancy
- subjects under the age of 18
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Periodontal Treatment on Salivary Biomarkers.
The investigators plan to recruit 40 healthy patients referred to the unit of Periodontology, diagnosed with generalized moderate - severe chronic periodontitis.
treatment will include 4 - 6 sessions of scaling + root planning, oral hygiene instructions and motivation.
Whole saliva will be collected at intake and 8 - 14 weeks post periodontal treatment.
Saliva will be analyzed for trans locator protein. Study hypothesis: Periodontal treatment has an affect on saliva components.
- Conditions
- Chronic Periodontitis
- Being tested
- periodontal treatment - scaling and root planning
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal treatment - scaling and root planningProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| periodontal treatmnent | Experimental | Not described Receives: Procedure: periodontal treatment - scaling and root planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole saliva & translocator protein (TSPO)
Change in whole saliva \& translocator protein (TSPO) post periodontal treatment
Measured: Intake of patients than 8 - 12 weeks after periodontal treatment (scaling & root planning)
Secondary outcomes (1)
Periodontal measurements (periodontal pocket depth, bleeding on probing & clinical attachment level)
periodontal probing depth, bleeding on probing and clinical attachment level.
Measured: Intake 8 - 12 weeks post periodontal treatment (scaling & root planning)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eran Front, The Baruch Padeh Medical Center, Poriya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159781
- Sponsor's protocol ID
- 2013-1476.CTIL
- Status last verified
- Jun 2014
- First submitted
- 28 May 2014
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Periodontal Treatment on Salivary Biomarkers.
- ClinicalTrials.gov ID
- NCT02159781
- Acronym / sponsor ID
- 2013-1476.CTIL
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- Jul 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 10 Jun 2014 (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 investigators plan to recruit 40 healthy patients referred to the unit of Periodontology, diagnosed with generalized moderate - severe chronic periodontitis.
treatment will include 4 - 6 sessions of scaling + root planning, oral hygiene instructions and motivation.
Whole saliva will be collected at intake and 8 - 14 weeks post periodontal treatment.
Saliva will be analyzed for trans locator protein. Study hypothesis: Periodontal treatment has an affect on saliva components.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| periodontal treatmnent | Experimental | Procedure: periodontal treatment - scaling and root planning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy patients
- moderate - sever chronic periodontitis
Key exclusion criteria (3 listed)
- systemic disease
- pregnancy
- subjects under the age of 18
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 |
|---|---|---|
| periodontal treatment - scaling and root planning | Procedure or surgery | periodontal treatmnent |
Primary outcome
Whole saliva & translocator protein (TSPO)
Time frame: Intake of patients than 8 - 12 weeks after periodontal treatment (scaling & root planning)
Change in whole saliva \& translocator protein (TSPO) post periodontal treatment
1 secondary outcome
Periodontal measurements (periodontal pocket depth, bleeding on probing & clinical attachment level)
Time frame: Intake 8 - 12 weeks post periodontal treatment (scaling & root planning)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing periodontal treatment - scaling and root planning in people with Chronic Periodontitis, run by The Baruch Padeh Medical Center, Poriya.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eran Front, DMD (+97246652254, efront@poria.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole saliva & translocator protein (TSPO) (time frame: Intake of patients than 8 - 12 weeks after periodontal treatment (scaling & root planning)). 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 Jun 2014.