PeriodontitisNCT05174494
Impact of Periodontal Treatment on NT-proBNP Levels
A study testing Evaluation of serum CRP and NT-proBNP in people with Periodontitis, run by University of Catania at 1 site in Italy.
Trial summary
In light of the controversy that are already approved but that however still exists regarding the efficacy and influence the management of Periodontitis, the aim of this study was to evaluates, at 6-months follow-up, the post-treatment clinical and serum parameters in patients with periodontitis, treated by either… Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Evaluation of serum CRP and NT-proBNP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2020to 30 Nov 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- good condition of general health
- a minimum of 2 teeth for each quadrant with
- Pocket Depth (PD) ranging from 4-6 mm
- no involvement of the furcation
- a minimum of a six teeth per quadrant, respectively
Who cannot join
- periodontal therapy during the last 12 months
- assumption of antibiotics during the last 6 months
- pregnancy
- any systemic condition which might affect the effects of the study treatment
- previous or current radiation or immunosuppressive therapies
- use of mouthwash containing antimicrobials during the previous 3 months
Show all 11Show fewer
- no use of hormonal contraceptives
- medication by anti-inflammatory and immunosuppressive drugs
- previous history of hard drinking
- smoking
- class II and III tooth mobility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Non Surgical Periodontal Treatment on Serum NT-proBNP Levels
In light of the controversy that are already approved but that however still exists regarding the efficacy and influence the management of Periodontitis, the aim of this study was to evaluates, at 6-months follow-up, the post-treatment clinical and serum parameters in patients with periodontitis, treated by either Intensive scaling and root planing (SRP) treatment versus conventional oral hygiene treatment on serum CRP and NT-proBNP levels.
The null hypothesis to invalidate was that there were no variations, in relation to clinical and serum CRP and NT-proBNP.
Read the detailed description
This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2016. The local ethical committee approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent.
Subjects with a diagnosis of periodontitis were enrolled in this clinical trial. The inclusion criteria were: 1) good condition of general health, 2) a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm, 3) no involvement of the furcation, 4) a minimum of a six teeth per quadrant, respectively. The exclusion criteria were: 1) periodontal therapy during the last 12 months, 2) assumption of antibiotics during the last 6 months, 3) pregnancy, 4) any systemic condition which might affect the effects of the study treatment, 5) previous or current radiation or immunosuppressive therapies, 5) use of mouthwash containing antimicrobials during the previous 3 months, 6) no use of hormonal contraceptives, 7) medication by anti-inflammatory and immunosuppressive drugs, 8) previous history of hard-drinking, 9) smoking, 10) class II and III tooth mobility. Patients randomly undergo to full mouth SRP (test group) or oral hygiene treatment (control group)
- Conditions
- Periodontitis
- Being tested
- Evaluation of serum CRP and NT-proBNP
- Keywords
- Periodontitis, serum markers, CRP, NT-proBNP
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of serum CRP and NT-proBNPDiagnostic test
All patients were evaluated to 6-months post-treatment reduction of serum CRP and NT-proBNP
| Study group | Role | What they receive |
|---|---|---|
| Full mouth non surgical periodontal treatment | Active comparator | Each selected subject underwent to full mouth SRP. Receives: Diagnostic Test: Evaluation of serum CRP and NT-proBNP |
| Control | Placebo comparator | Each selected subject underwent full mouth traditional oral hygiene. Receives: Diagnostic Test: Evaluation of serum CRP and NT-proBNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Clinical Attachment Level
Change of periodontal Clinical Attachment Level
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start2 Jan 2020
- Primary completion20 Sep 2022
- Study completion30 Nov 2022
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
- Model description
- Each selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Scaling and Root Planing (SRP), while the control group undergo to standard oral hygiene treatment.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, University of Catania
- Investigators
- Gaetano Isola, Principal investigator, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174494
- Sponsor's protocol ID
- 121/20/PO
- Status last verified
- Jan 2023
- First submitted
- 13 Dec 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publish study results and IDP sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non Surgical Periodontal Treatment on Serum NT-proBNP Levels
- ClinicalTrials.gov ID
- NCT05174494
- Acronym / sponsor ID
- 121/20/PO
- Conditions
- Periodontitis
- Keywords
- Periodontitis, serum markers, CRP, NT-proBNP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 30 Dec 2021 (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.
In light of the controversy that are already approved but that however still exists regarding the efficacy and influence the management of Periodontitis, the aim of this study was to evaluates, at 6-months follow-up, the post-treatment clinical and serum parameters in patients with periodontitis, treated by either Intensive scaling and root planing (SRP) treatment versus conventional oral hygiene treatment on serum CRP and NT-proBNP levels.
The null hypothesis to invalidate was that there were no variations, in relation to clinical and serum CRP and NT-proBNP.
Detailed description
This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2016. The local ethical committee approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent.
Subjects with a diagnosis of periodontitis were enrolled in this clinical trial. The inclusion criteria were: 1) good condition of general health, 2) a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm, 3) no involvement of the furcation, 4) a minimum of a six teeth per quadrant, respectively. The exclusion criteria were: 1) periodontal therapy during the last 12 months, 2) assumption of antibiotics during the last 6 months, 3) pregnancy, 4) any systemic condition which might affect the effects of the study treatment, 5) previous or current radiation or immunosuppressive therapies, 5) use of mouthwash containing antimicrobials during the previous 3 months, 6) no use of hormonal contraceptives, 7) medication by anti-inflammatory and immunosuppressive drugs, 8) previous history of hard-drinking, 9) smoking, 10) class II and III tooth mobility. Patients randomly undergo to full mouth SRP (test group) or oral hygiene treatment (control group)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Each selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Scaling and Root Planing (SRP), while the control group undergo to standard oral hygiene treatment.
| Arm | Type | Receives |
|---|---|---|
| Full mouth non surgical periodontal treatment | Active comparator | Diagnostic Test: Evaluation of serum CRP and NT-proBNPEach selected subject underwent to full mouth SRP. |
| Control | Placebo comparator | Diagnostic Test: Evaluation of serum CRP and NT-proBNPEach selected subject underwent full mouth traditional oral hygiene. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- good condition of general health
- a minimum of 2 teeth for each quadrant with
- Pocket Depth (PD) ranging from 4-6 mm
- no involvement of the furcation
- a minimum of a six teeth per quadrant, respectively
Key exclusion criteria (11 listed)
- periodontal therapy during the last 12 months
- assumption of antibiotics during the last 6 months
- pregnancy
- any systemic condition which might affect the effects of the study treatment
- previous or current radiation or immunosuppressive therapies
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 |
|---|---|---|
| Evaluation of serum CRP and NT-proBNPAll patients were evaluated to 6-months post-treatment reduction of serum CRP and NT-proBNP | Diagnostic test | Control, Full mouth non surgical periodontal treatment |
Primary outcome
Change of Clinical Attachment Level
Time frame: 6-months
Change of periodontal Clinical Attachment Level
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 31 Jan 2023.
- Individual participant dataSharing planned: Yes. Publish study results and IDP sharing plan
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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.
Gaetano Isola principal investigator
University of Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of serum CRP and NT-proBNP in people with Periodontitis, run by University of Catania 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 11 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 31 Jan 2023. 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. 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?
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?
Change of Clinical Attachment Level (time frame: 6-months). 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 31 Jan 2023.