Periodontal DiseasesPERIOTENSIONNCT04328389
Periodontal Management in Hypertensive Patients (PERIOTENSION Trial I)
A study testing electric toothbrush and Professional oral hygiene in people with Periodontal Diseases and Gingivitis, run by University of L'Aquila.
Trial summary
Treated hypertensive patients with any form of periodontal diseases will be randomized to either supragingival dental plaque removal using electric toothbrushes at home or intensive professional oral hygiene treatment and the effects on blood pressure will be identified. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Periodontal Diseases, Gingivitis, Hypertension
- What is being tested?
- electric toothbrush and Professional oral hygiene
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Dec 2024
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treated hypertension
- Have at least 20 natural teeth
- Presence of any form of periodontal diseases according to guidelines
- Absence of other significant oral infections.
Who cannot join
- Secondary hypertension (known plasma renin screening, abdominal ultrasound with doppler and other investigations)
- Individual is pregnant or nursing
- Primary pulmonary hypertension
- Professional oral hygine within past 6 months
- Flu, rhinitis, sinusitis etc. within past 4 weeks
- Use of antibiotics within past 4 weeks
Show all 13Show fewer
- Hospitalization for any reason within the past 3 months
- Allergic disorders; History of chronic infectious disease,
- Chronic hepatitis B or C infection
- Chronic Obstructive Pulmonary Disease (COPD), tuberculosis
- Other known chronic inflammatory or autoimmune condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease
- Use of systemic or local steroids or immunosuppressive agents within 6 months of the inclusion.
- History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week
Trial locations and contacts
No sites are listed yet.
Rita Del Pinto, MD. PhD contact
About this study
Official title: Periodontal Management in Hypertensive Patients
Treated hypertensive patients with any form of periodontal diseases will be randomized to either supragingival dental plaque removal using electric toothbrushes at home or intensive professional oral hygiene treatment and the effects on blood pressure will be identified.
- Conditions
- Periodontal Diseases, Gingivitis, Hypertension
- Being tested
- electric toothbrush, Professional oral hygiene
- Medical subject headings
- Periodontal Diseases, Gingivitis, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electric toothbrushBehavioural
Participants will be instructed to use their electric toothbrushes twice a day for controlling oral plaque
Professional oral hygieneProcedure or surgery
Professional oral hygiene using ultrosound scaling and root planing
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator: electric toothbrush | Placebo comparator | Participats will be instructed to used electric toothbrush for home supragingival plaque removal Receives: Behavioral: electric toothbrush |
| Professional oral hygiene | Experimental | Full-Mouth professional oral hygiene consisting in scaling and root planing, four quadrants in one session. Receives: Procedure: Professional oral hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and Diastolic Blood Pressure Change
Ambulatory Blood Pressure Monitoring
Measured: 1 week
Secondary outcomes (1)
Systolic and Diastolic Blood Pressure Change
Unattented Blood Pressure Measurement
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study startJun 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Pietropaoli, University of L'Aquila
- Investigators
- Rita Del Pinto, MD, PhD, Principal investigator, University of L'Aquila Unit of Internal Medicine and Nephrology - Center for HypertensionDavide Pietropaoli, DDS, PhD, Principal investigator, University of L'Aquila - Unit of Oral Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328389
- Sponsor's protocol ID
- AQ2020
- Acronym
- PERIOTENSION
- Status last verified
- Apr 2021
- First submitted
- 27 Mar 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pietropaoli D, Del Pinto R, Ferri C, Wright JT Jr, Giannoni M, Ortu E, Monaco A. Poor Oral Health and Blood Pressure Control Among US Hypertensive Adults. Hypertension. 2018 Dec;72(6):1365-1373. doi: 10.1161/HYPERTENSIONAHA.118.11528.
PubMed 30540406Pietropaoli D, Del Pinto R, Ferri C, Ortu E, Monaco A. Definition of hypertension-associated oral pathogens in NHANES. J Periodontol. 2019 Aug;90(8):866-876. doi: 10.1002/JPER.19-0046. Epub 2019 May 29.
PubMed 31090063Pietropaoli D, Del Pinto R, Ferri C, Marzo G, Giannoni M, Ortu E, Monaco A. Association between periodontal inflammation and hypertension using periodontal inflamed surface area and bleeding on probing. J Clin Periodontol. 2020 Feb;47(2):160-172. doi: 10.1111/jcpe.13216. Epub 2019 Nov 26.
PubMed 31680283
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Management in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT04328389
- Acronym / sponsor ID
- PERIOTENSION / AQ2020
- Conditions
- Periodontal Diseases, Gingivitis, Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 Mar 2020 (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.
Treated hypertensive patients with any form of periodontal diseases will be randomized to either supragingival dental plaque removal using electric toothbrushes at home or intensive professional oral hygiene treatment and the effects on blood pressure will be identified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator: electric toothbrush | Placebo comparator | Behavioral: electric toothbrushParticipats will be instructed to used electric toothbrush for home supragingival plaque removal |
| Professional oral hygiene | Experimental | Procedure: Professional oral hygieneFull-Mouth professional oral hygiene consisting in scaling and root planing, four quadrants in one session. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Treated hypertension
- Have at least 20 natural teeth
- Presence of any form of periodontal diseases according to guidelines
- Absence of other significant oral infections.
Key exclusion criteria (13 listed)
- Secondary hypertension (known plasma renin screening, abdominal ultrasound with doppler and other investigations)
- Individual is pregnant or nursing
- Primary pulmonary hypertension
- Professional oral hygine within past 6 months
- Flu, rhinitis, sinusitis etc. within past 4 weeks
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 |
|---|---|---|
| electric toothbrushParticipants will be instructed to use their electric toothbrushes twice a day for controlling oral plaque | Behavioural | Placebo Comparator: electric toothbrush |
| Professional oral hygieneProfessional oral hygiene using ultrosound scaling and root planing | Procedure or surgery | Professional oral hygiene |
Primary outcome
Systolic and Diastolic Blood Pressure Change
Time frame: 1 week
Ambulatory Blood Pressure Monitoring
1 secondary outcome
Systolic and Diastolic Blood Pressure Change
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 30540406Pietropaoli D, Del Pinto R, Ferri C, Wright JT Jr, Giannoni M, Ortu E, Monaco A. Poor Oral Health and Blood Pressure Control Among US Hypertensive Adults. Hypertension. 2018 Dec;72(6):1365-1373. doi: 10.1161/HYPERTENSIONAHA.118.11528.
- Background: PubMed 31090063Pietropaoli D, Del Pinto R, Ferri C, Ortu E, Monaco A. Definition of hypertension-associated oral pathogens in NHANES. J Periodontol. 2019 Aug;90(8):866-876. doi: 10.1002/JPER.19-0046. Epub 2019 May 29.
- Background: PubMed 31680283Pietropaoli D, Del Pinto R, Ferri C, Marzo G, Giannoni M, Ortu E, Monaco A. Association between periodontal inflammation and hypertension using periodontal inflamed surface area and bleeding on probing. J Clin Periodontol. 2020 Feb;47(2):160-172. doi: 10.1111/jcpe.13216. Epub 2019 Nov 26.
- 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. This study is not recruiting at the moment.
Rita Del Pinto, MD. PhD contact
Rita Del Pinto, MD, PhD principal investigator
University of L'Aquila Unit of Internal Medicine and Nephrology - Center for Hypertension
Davide Pietropaoli, DDS, PhD principal investigator
University of L'Aquila - Unit of Oral Diseases
Questions about this trial
What is this clinical trial studying?
A study testing electric toothbrush and Professional oral hygiene in people with Periodontal Diseases and Gingivitis, run by University of L'Aquila.
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 4 inclusion and 13 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 28 Apr 2021. 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. 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 Davide Pietropaoli, DDS, PhD (+39 0862 434974, davide.pietropaoli@univaq.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and Diastolic Blood Pressure Change (time frame: 1 week). 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 NCT04328389, which also lists 3 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 28 Apr 2021.