PeriodontitisPerioBPNCT02131922
Study of the Effects of Intensive Treatment of Periodontitis on Blood Pressure Control
A study testing Intensive Treatment, Dental Hygienization Treatment and Chlorhexidine (Intensive Treatment) in people with Periodontitis and Hypertension, run by Jagiellonian University at 2 sites in Poland.
Trial summary
Hypertensive patients with chronic periodontitis will be randomized to either intensive treatment or supragingival hygienic treatment and the effects on blood pressure will be identified. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Periodontitis, Hypertension
- What is being tested?
- Intensive Treatment, Dental Hygienization Treatment and Chlorhexidine (Intensive Treatment)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesPoland
- Study dates
- Sep 2009to Sep 2014
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Periodontitis with three or more periodontal pockets with a probing depth (PD) > 5mm
- Bleeding of these periodontal pockets on probing
- Have at least 20 natural teeth
- Provide informed consent and willingness to cooperate with the study protocol
- Age >25 years old
- Absence of other significant oral infections.
- Primary Hypertension on stable treatment
Who cannot join
- Clinical symptoms of acute inflammatory disorders incl flu, rhinitis, sinusitis etc. within past 3 weeks
- Hospitalization for any reason within the past 3 months; Life expectancy of < 3 years;
- Allergic disorders; History of chronic infectious disease, Chronic Obstructive Pulmonary Disease (COPD), tuberculosis; chronic hepatitis B or C infection; interstitial pneumonitis, bronchiectasis; known chronic pericardial effusion, pleural effusion, or ascites; liver disease;
- Other known chronic inflammatory or autoimmune condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease
- Secondary hypertension (known plasma renin screening, abdominal ultrasound with doppler and other investigations)
- Non-basal cell malignancy or treated myelo or lymphoproliferative disease within the past 5 years;
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- Known HIV positive; Immunizations within past 3 months
- Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
- Primary pulmonary hypertension.
- Use of systemic or local steroids or immunosuppressive agents within 6 months of the inclusion.
- Individual is pregnant or nursing
- History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 1 recruiting
- Active, not recruiting
J. Dietl Hospital, Department of Internal and Agricultural Medicine, Jagiellonian University
Krakow, 31-121
- Recruiting
Jagiellonian University Dental Clinic
Krakow
Marta Czesnikiewicz-Guzik, 66683950, maczesni@yahoo.co.uk
Daniel Nowakowski, DMD
About this study
Official title: Study of the Effects of Intensive Treatment of Periodontitis on Blood Pressure Control and Vascular Function
Hypertensive patients with chronic periodontitis will be randomized to either intensive treatment or supragingival hygienic treatment and the effects on blood pressure will be identified.
- Conditions
- Periodontitis, Hypertension
- Being tested
- Intensive Treatment, Dental Hygienization Treatment, Chlorhexidine (Intensive Treatment)
- Medical subject headings
- Periodontitis, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive TreatmentProcedure or surgery
Also called Intensive Surgical Treatment of Periodontitis
Intensive Surgical Treatment of Periodontitis
Dental Hygienization TreatmentProcedure or surgery
Chlorhexidine (Intensive Treatment)Drug
Chlorhexidine (PerioKIN) (0.2%) implantation in dental pockets
| Study group | Role | What they receive |
|---|---|---|
| Hygenization Treatment | Placebo comparator | Basic oral hygiene instructions Supragingival plaque removal Receives: Procedure: Dental Hygienization Treatment |
| Intensive Treatment | Experimental | One-Stage Full-Mouth Disinfection. Scaling and root planing, four quadrants in one session. Extraction of radix relicta. Subgingival chlorhexidine (PerioKIN) (0.2%) in all pockets. Oral hygiene instructions. Receives: Procedure: Intensive Treatment; Drug: Chlorhexidine (Intensive Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Change
Ambulatory Blood Pressure Monitoring
Measured: 3 months
Secondary outcomes (1)
Flow Mediated Dilatation
Vascular Function Measurement
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startSep 2009
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Guzik, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131922
- Sponsor's protocol ID
- MOMT-01A
- Acronym
- PerioBP
- Status last verified
- May 2014
- First submitted
- 28 Apr 2014
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Czesnikiewicz-Guzik M, Osmenda G, Siedlinski M, Nosalski R, Pelka P, Nowakowski D, Wilk G, Mikolajczyk TP, Schramm-Luc A, Furtak A, Matusik P, Koziol J, Drozdz M, Munoz-Aguilera E, Tomaszewski M, Evangelou E, Caulfield M, Grodzicki T, D'Aiuto F, Guzik TJ. Causal association between periodontitis and hypertension: evidence from Mendelian randomization and a randomized controlled trial of non-surgical periodontal therapy. Eur Heart J. 2019 Nov 1;40(42):3459-3470. doi: 10.1093/eurheartj/ehz646.
PubMed 31504461
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Intensive Treatment of Periodontitis on Blood Pressure Control and Vascular Function
- ClinicalTrials.gov ID
- NCT02131922
- Acronym / sponsor ID
- PerioBP / MOMT-01A
- Conditions
- Periodontitis, Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 6 May 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.
Hypertensive patients with chronic periodontitis will be randomized to either intensive treatment or supragingival hygienic treatment and the effects on blood pressure will be identified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hygenization Treatment | Placebo comparator | Procedure: Dental Hygienization TreatmentBasic oral hygiene instructions Supragingival plaque removal |
| Intensive Treatment | Experimental | Procedure: Intensive Treatment, Drug: Chlorhexidine (Intensive Treatment)One-Stage Full-Mouth Disinfection. Scaling and root planing, four quadrants in one session. Extraction of radix relicta. Subgingival chlorhexidine (PerioKIN) (0.2%) in all pockets. Oral hygiene instructions. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Periodontitis with three or more periodontal pockets with a probing depth (PD) > 5mm
- Bleeding of these periodontal pockets on probing
- Have at least 20 natural teeth
- Provide informed consent and willingness to cooperate with the study protocol
- Age >25 years old
Key exclusion criteria (12 listed)
- Clinical symptoms of acute inflammatory disorders incl flu, rhinitis, sinusitis etc. within past 3 weeks
- Hospitalization for any reason within the past 3 months; Life expectancy of < 3 years;
- Allergic disorders; History of chronic infectious disease, Chronic Obstructive Pulmonary Disease (COPD), tuberculosis; chronic hepatitis B or C infection; interstitial pneumonitis, bronchiectasis; known chronic pericardial effusion, pleural effusion, or ascites; liver disease;
- Other known chronic inflammatory or autoimmune condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease
- Secondary hypertension (known plasma renin screening, abdominal ultrasound with doppler and other investigations)
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 |
|---|---|---|
| Intensive TreatmentAlso: Intensive Surgical Treatment of PeriodontitisIntensive Surgical Treatment of Periodontitis | Procedure or surgery | Intensive Treatment |
| Dental Hygienization Treatment | Procedure or surgery | Hygenization Treatment |
| Chlorhexidine (Intensive Treatment)Chlorhexidine (PerioKIN) (0.2%) implantation in dental pockets | Drug | Intensive Treatment |
Primary outcome
Blood Pressure Change
Time frame: 3 months
Ambulatory Blood Pressure Monitoring
1 secondary outcome
Flow Mediated Dilatation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
- Derived from this study: PubMed 31504461Czesnikiewicz-Guzik M, Osmenda G, Siedlinski M, Nosalski R, Pelka P, Nowakowski D, Wilk G, Mikolajczyk TP, Schramm-Luc A, Furtak A, Matusik P, Koziol J, Drozdz M, Munoz-Aguilera E, Tomaszewski M, Evangelou E, Caulfield M, Grodzicki T, D'Aiuto F, Guzik TJ. Causal association between periodontitis and hypertension: evidence from Mendelian randomization and a randomized controlled trial of non-surgical periodontal therapy. Eur Heart J. 2019 Nov 1;40(42):3459-3470. doi: 10.1093/eurheartj/ehz646.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Treatment, Dental Hygienization Treatment and Chlorhexidine (Intensive Treatment) in people with Periodontitis and Hypertension, run by Jagiellonian University at 2 sites in Poland.
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 7 inclusion and 12 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 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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. Some participants in this study may receive a placebo. 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 Marta Czesnikiewicz-Guzik, MD PhD (66683950, maczesni@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Change (time frame: 3 months). 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 NCT02131922, which also lists 1 linked publication.
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 6 May 2014.