PeriodontitisPERIO-HYPERTENNCT03122990
Acute-phase Response & Periodontal Treatment in Patients With Hypertension
A study testing FM-SRP and Q-SRP in people with Periodontitis and Hypertension, run by University of Pisa at 1 site in Italy.
Trial summary
The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus full-mouth treatment (FM-SRP) in terms of acute-phase responses following non surgical periodontal treatment in patients affected by periodontitis and high blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Periodontitis, Hypertension
- What is being tested?
- FM-SRP and Q-SRP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2016to 30 Jun 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients affected by Periodontal Disease
- 20% of periodontal pockets of the entire dentition
- 20% bleeding on probing of the entire dentition
- Documented radiographic bone loss
- Diagnosis of Hypertension as measured through international standards
Who cannot join
- age younger than 18 years and older than 80 years
- pregnant or lactating females
- need of antibiotic coverage for periodontal treatment
- treatment with statins and/or acetylsalicylic acid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute-phase Response & Periodontal Treatment in Patients With High Blood Pressure
The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus full-mouth treatment (FM-SRP) in terms of acute-phase responses following non surgical periodontal treatment in patients affected by periodontitis and high blood pressure.
Read the detailed description
Periodontal treatment, consisting in both supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planing), will be performed by a single periodontist on patients with periodontitis and hypertension.
The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus full-mouth treatment (FM-SRP) in terms of acute-phase responses following non surgical periodontal treatment in patients affected by periodontitis and high blood pressure.
Treatment will be provided using both hand and ultrasonic instrumentation with fine tips.
FM-SRP patients will received treatment within 24 h. Q-SRP patients will received four quadrants sessions of periodontal treatment with an interval of 1 week between sessions.
Vital, endothelial function and blood inflammatory parameters will be evaluated at baseline, 24 hours after the first treatment and after 3 months. Periodontal parameters will be evaluated at baseline and after 3 months.
- Conditions
- Periodontitis, Hypertension
- Being tested
- FM-SRP, Q-SRP
- Medical subject headings
- Periodontitis, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FM-SRPProcedure or surgery
Also called Full mouth scaling and root planing
Supra- and sub-gingival mechanical instrumentation of the root surface of the whole dentition within 24 hours.
Q-SRPProcedure or surgery
Also called Quadrant scaling and root planing
Supra- and sub-gingival mechanical instrumentation of the root surface will be performed in all dentition subdivided in four appointments. Each appointment will be performed in one week interval. In each appointment only a "quadrant" of the dentition will be instrumented.Performed in 3 weeks time frame.
| Study group | Role | What they receive |
|---|---|---|
| Full mouth scaling and root planing | Experimental | FM-SRP No surgical periodontal treatment will be performed in all dentition within 24 hours Receives: Procedure: FM-SRP |
| Quadrant Scaling and Root Planing | Active comparator | Q-SRP No surgical periodontal treatment will be performed in all dentition subdivided in four appointments. Each appointment will be performed in one week interval. In each appointment only a "quadrant" of the dentition will be instrumented. Receives: Procedure: Q-SRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels C-Reactive Protein
Changes in C reactive protein (CRP). Unit of measure: mg/L
Measured: Baseline, 24 hours and 3 months after treatment
Secondary outcomes (15)
Full Mouth Plaque Score (FMPS)
Changes in FMPS. Unit of Measure: %
Measured: Baseline and 3 months after treatment
Full Mouth Bleeding Score (FMBS)
Changes in FMBS. Unit of Measure: %
Measured: Baseline and 3 months after treatment
Pocket probing depth (PPD)
Changes in PPD. Unit of Measure: mm
Measured: Baseline and 3 months after treatment
Clinical attachment level (CAL)
Changes in CAL. Unit of Measure: mm
Measured: Baseline and 3 months after treatment
Recession of the gingival margin (REC)
Changes in REC. Unit of Measure: mm
Measured: Baseline and 3 months after treatment
Triglycerides
Changes in triglycerides. Unit of measure: mmol/L
Measured: Baseline, 24 hours and 3 months after treatment
Low-density lipoprotein (LDL)
Changes in LDL. Unit of measure: mmol/L
Measured: Baseline, 24 hours and 3 months after treatment
High-density lipoprotein (HDL)
Changes in HDL. Unit of measure: mmol/L
Measured: Baseline, 24 hours and 3 months after treatment
Cholesterol
Changes in total cholesterol. Unit of measure: mmol/L
Measured: Baseline, 24 hours and 3 months after treatment
Glycaemia
Changes in blood glucose level; Unit of measure: mg/dL
Measured: Baseline, 24 hours and 3 months after treatment
Glycated Hemoglobin
Changes in Glycated Hemoglobin level; Unit of measure: mmol/mol
Measured: Baseline and 3 months after treatment
Insulin
Changes in Insulin level; Unit of measure: μU/mL
Measured: Baseline, 24 hours and 3 months after treatment
Systolic Blood Pressure (SBP)
Changes in SBP; Unit of measure: mmHg
Measured: Baseline, 24 hours and 3 months after treatment
Diastolic Blood Pressure (DBP)
Changes in DBP; Unit of measure: mmHg
Measured: Baseline, 24 hours and 3 months after treatment
Endothelial Function
Measures of endothelial function taken through Flow-Mediated dilation. Unit of Measure: %
Measured: Baseline, 24 hours and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Jun 2016
- Primary completion31 Dec 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filippo Graziani, DDS MClinDent PhD, University of Pisa
- Investigators
- Filippo Graziani, DDS, PhD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122990
- Sponsor's protocol ID
- 3399/11_C
- Acronym
- PERIO-HYPERTEN
- Status last verified
- Nov 2020
- First submitted
- 8 Mar 2017
- Last updated
- 4 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute-phase Response & Periodontal Treatment in Patients With High Blood Pressure
- ClinicalTrials.gov ID
- NCT03122990
- Acronym / sponsor ID
- PERIO-HYPERTEN / 3399/11_C
- Conditions
- Periodontitis, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 21 Apr 2017 (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.
The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus full-mouth treatment (FM-SRP) in terms of acute-phase responses following non surgical periodontal treatment in patients affected by periodontitis and high blood pressure.
Detailed description
Periodontal treatment, consisting in both supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planing), will be performed by a single periodontist on patients with periodontitis and hypertension.
The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus full-mouth treatment (FM-SRP) in terms of acute-phase responses following non surgical periodontal treatment in patients affected by periodontitis and high blood pressure.
Treatment will be provided using both hand and ultrasonic instrumentation with fine tips.
FM-SRP patients will received treatment within 24 h. Q-SRP patients will received four quadrants sessions of periodontal treatment with an interval of 1 week between sessions.
Vital, endothelial function and blood inflammatory parameters will be evaluated at baseline, 24 hours after the first treatment and after 3 months. Periodontal parameters will be evaluated at baseline and after 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full mouth scaling and root planing | Experimental | Procedure: FM-SRPFM-SRP No surgical periodontal treatment will be performed in all dentition within 24 hours |
| Quadrant Scaling and Root Planing | Active comparator | Procedure: Q-SRPQ-SRP No surgical periodontal treatment will be performed in all dentition subdivided in four appointments. Each appointment will be performed in one week interval. In each appointment only a "quadrant" of the dentition will be instrumented. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients affected by Periodontal Disease
- 20% of periodontal pockets of the entire dentition
- 20% bleeding on probing of the entire dentition
- Documented radiographic bone loss
- Diagnosis of Hypertension as measured through international standards
Key exclusion criteria (4 listed)
- age younger than 18 years and older than 80 years
- pregnant or lactating females
- need of antibiotic coverage for periodontal treatment
- treatment with statins and/or acetylsalicylic acid
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 |
|---|---|---|
| FM-SRPAlso: Full mouth scaling and root planingSupra- and sub-gingival mechanical instrumentation of the root surface of the whole dentition within 24 hours. | Procedure or surgery | Full mouth scaling and root planing |
| Q-SRPAlso: Quadrant scaling and root planingSupra- and sub-gingival mechanical instrumentation of the root surface will be performed in all dentition subdivided in four appointments. Each appointment will be performed in one week interval. In each appointment only a "quadrant" of the dentition will be instrumented.Performed in 3 weeks time frame. | Procedure or surgery | Quadrant Scaling and Root Planing |
Primary outcome
Levels C-Reactive Protein
Time frame: Baseline, 24 hours and 3 months after treatment
Changes in C reactive protein (CRP). Unit of measure: mg/L
15 secondary outcomes
Full Mouth Plaque Score (FMPS)
Time frame: Baseline and 3 months after treatment
Full Mouth Bleeding Score (FMBS)
Time frame: Baseline and 3 months after treatment
Pocket probing depth (PPD)
Time frame: Baseline and 3 months after treatment
Clinical attachment level (CAL)
Time frame: Baseline and 3 months after treatment
Recession of the gingival margin (REC)
Time frame: Baseline and 3 months after treatment
Triglycerides
Time frame: Baseline, 24 hours and 3 months after treatment
Low-density lipoprotein (LDL)
Time frame: Baseline, 24 hours and 3 months after treatment
High-density lipoprotein (HDL)
Time frame: Baseline, 24 hours and 3 months after treatment
Cholesterol
Time frame: Baseline, 24 hours and 3 months after treatment
Glycaemia
Time frame: Baseline, 24 hours and 3 months after treatment
Glycated Hemoglobin
Time frame: Baseline and 3 months after treatment
Insulin
Time frame: Baseline, 24 hours and 3 months after treatment
Systolic Blood Pressure (SBP)
Time frame: Baseline, 24 hours and 3 months after treatment
Diastolic Blood Pressure (DBP)
Time frame: Baseline, 24 hours and 3 months after treatment
Endothelial Function
Time frame: Baseline, 24 hours and 3 months after treatment
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 4 Nov 2020.
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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.
Filippo Graziani, DDS, PhD principal investigator
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FM-SRP and Q-SRP in people with Periodontitis and Hypertension, run by University of Pisa at 1 site in Italy.
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 5 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 4 Nov 2020. 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 Italy. 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?
Levels C-Reactive Protein (time frame: Baseline, 24 hours and 3 months after treatment). 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 4 Nov 2020.