Periodontal DiseasesPERIOSYST-1NCT02460926

Acute Phase Response & Periodontal Treatment

A study testing Scaling & Root Planing in people with Periodontal Diseases, run by University of Pisa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Periodontal Diseases
What is being tested?: Scaling & Root Planing
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: No sites listed yet
Study dates: May 2012to Oct 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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients presenting with probing pocket depths (PPD) ≥5 mm,
bleeding on probing on at least 25% of their total sites
documented radiographic alveolar bone loss

Who cannot join

age earlier than 18 and older than 70 years;
pregnant or lactating females;
females using contraceptive methods;
reported diagnosis of any systemic illnesses including cardiovascular, renal and liver diseases;
any pharmacological treatment within the 3 months before the beginning of the study;
PT in the previous 6 months.

About this study

Official title: Acute Phase Response Following Full Mouth Versus Quadrant Non-Surgical Periodontal Treatment. A Randomized Clinical Trial

This study has compared quadrant scaling and root planing (Q-SRP) versus intensive treatment performed within 24 hours (FM-SRP) in terms of acute phase responses following treatment of periodontal disease. The primary aim was to compare the differences in CRP acute increase following FM-SRP versus Q-SRP therapy (24 hours after therapy). Secondary outcomes included changes in a broad array of inflammatory and endothelial injury markers between groups. Patients were randomly assigned to either FM-SRP and Q-SRP. Data indicated that non-surgical periodontal therapy performed within 24 hours induced greater perturbations of systemic inflammation compared to conventional treatment.

Read the detailed description

Aim. A moderate acute-phase response occurs 24 hours following full-mouth non-surgical treatment (FM-SRP). Aim of this study will be to compare quadrant scaling (Q-SRP) versus FM-SRP in terms of systemic acute (24 hours) and medium-term (3 months) inflammation.

Material \& Methods. 38 periodontitis-affected subjects will be randomly allocated to FM-SRP or Q-SRP after a baseline visit. Periodontal and anthropometric parameters, such as systolic and diastolic bood pressure, BMI and temperature, will be collected at baseline and 3 months. Serum samples will be drawn at baseline, 1, 7 and 90 days after treatment. High sensitivity assays for a broad array of inflammatory (PCR, IL-6, TNF-alpha) and endothelial assays will be performed.

Conditions: Periodontal Diseases
Being tested: Scaling & Root Planing
Keywords: Scaling and root planning, C-reactive protein
Medical subject headings: Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Scaling & Root PlaningProcedure or surgery
Also called SRP
It consists in the non-surgical debridement of the sub gingival area affected by periodontal disease

Study groups in NCT02460926
Study group	Role	What they receive
Scaling & Root Planing - Quadrant	Experimental	Periodontal treatment (PT), consisting in both supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planing), was performed by a single periodontist . Treatment was provided using both hand and ultrasonic instrumentation with fine tips. Local anaesthesia was used when needed and no time constraints were enforced. Q-SRP patients received four quadrants sessions of PT with an interval of 1 week between sessions Receives: Procedure: Scaling & Root Planing
Scaling & Root Planing - Full Mouth	Experimental	Periodontal treatment (PT), consisting in both supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planing), was performed by a single periodontist . Treatment was provided using both hand and ultrasonic instrumentation with fine tips. Local anaesthesia was used when needed and no time constraints were enforced. FM-SRP patients received treatment within 24 hrs in two separate sessions, one side of the mouth for each session: two quadrants were instrumented in an afternoon session, whereas the other two were instrumented the following morning Receives: Procedure: Scaling & Root Planing

What is being measured

The primary outcome is the main question the study is designed to answer.

C reactive Protein
Measured: 24 Hours

Secondary outcomes (9)

C reactive Protein
Measured: 7 days, 90 days
Tumor Necrosis Factor - alpha
Measured: 24 Hours, 7 days, 90 days
Interleukin - 6
Measured: 24 Hours, 7 days, 90 days
periodontal pocket depth (PPD)
mean in mm
Measured: 90 days
periodontal pocket depth (PPD)
mean in site > 4mm
Measured: 90 days
clinical attachment level (CAL)
mean in mm
Measured: 90 days
number of pockets > 4 mm
number of pockets > 4 mm
Measured: 90 days
Full Mouth Plaque Score
presence/absence of dental plaque in percentual values
Measured: 90 days
Full Mouth Bleeding Score
presence/absence of sites bleeding on probing in percentual values
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Oct 2014

First posted3 Jun 2015 (estimated)
Study startMay 2012
Primary completionOct 2013
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)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: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02460926
Sponsor's protocol ID: 3399/11
Acronym: PERIOSYST-1
Status last verified: May 2015
First submitted: 28 May 2015
Last updated: 3 Jun 2015
Results posted: No
Data monitoring committee: No

Publications

Graziani F, Cei S, La Ferla F, Vano M, Gabriele M, Tonetti M. Effects of non-surgical periodontal therapy on the glomerular filtration rate of the kidney: an exploratory trial. J Clin Periodontol. 2010 Jul;37(7):638-43. doi: 10.1111/j.1600-051X.2010.01578.x. Epub 2010 May 25.
PubMed 20500539
Graziani F, Cei S, Tonetti M, Paolantonio M, Serio R, Sammartino G, Gabriele M, D'Aiuto F. Systemic inflammation following non-surgical and surgical periodontal therapy. J Clin Periodontol. 2010 Sep;37(9):848-54. doi: 10.1111/j.1600-051X.2010.01585.x. Epub 2010 Jun 4.
PubMed 20546085

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
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Effects Of Periodontal Therapy In Patients With Inflammatory Bowel Disease
Periodontal Diseases, IBD
RecruitingObservational study
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
Immunosuppression, Periodontal Disease
Active, not recruiting
NON-SURGİCAL PERİODONTAL THERAPY WİTH L-ARGİNİNE
Periodontal Disease, Periodontal Diseases
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth

All Periodontal Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute Phase Response Following Full Mouth Versus Quadrant Non-Surgical Periodontal Treatment. A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT02460926
Acronym / sponsor ID: PERIOSYST-1 / 3399/11
Conditions: Periodontal Diseases
Keywords: Scaling and root planning, C-reactive protein
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: University of PisaUniversity, hospital or other
Collaborators: Eastman Dental Insitute and Hospital
Study start: May 2012
Primary completion: Oct 2013 (actual)
Study completion: Oct 2014 (actual)
First posted: 3 Jun 2015 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Scaling & Root Planing - Quadrant	Experimental	Procedure: Scaling & Root PlaningPeriodontal treatment (PT), consisting in both supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planing), was performed by a single periodontist . Treatment was provided using both hand and ultrasonic instrumentation with fine tips. Local anaesthesia was used when needed and no time constraints were enforced. Q-SRP patients received four quadrants sessions of PT with an interval of 1 week between sessions
Scaling & Root Planing - Full Mouth	Experimental	Procedure: Scaling & Root PlaningPeriodontal treatment (PT), consisting in both supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planing), was performed by a single periodontist . Treatment was provided using both hand and ultrasonic instrumentation with fine tips. Local anaesthesia was used when needed and no time constraints were enforced. FM-SRP patients received treatment within 24 hrs in two separate sessions, one side of the mouth for each session: two quadrants were instrumented in an afternoon session, whereas the other two were instrumented the following morning

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients presenting with probing pocket depths (PPD) ≥5 mm,
bleeding on probing on at least 25% of their total sites
documented radiographic alveolar bone loss

Key exclusion criteria (6 listed)

age earlier than 18 and older than 70 years;
pregnant or lactating females;
females using contraceptive methods;
reported diagnosis of any systemic illnesses including cardiovascular, renal and liver diseases;
any pharmacological treatment within the 3 months before the beginning of the study;

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
Scaling & Root PlaningAlso: SRPIt consists in the non-surgical debridement of the sub gingival area affected by periodontal disease	Procedure or surgery	Scaling & Root Planing - Full Mouth, Scaling & Root Planing - Quadrant

Primary outcome

C reactive Protein
Time frame: 24 Hours

9 secondary outcomes

C reactive Protein
Time frame: 7 days, 90 days
Tumor Necrosis Factor - alpha
Time frame: 24 Hours, 7 days, 90 days
Interleukin - 6
Time frame: 24 Hours, 7 days, 90 days
periodontal pocket depth (PPD)
Time frame: 90 days
periodontal pocket depth (PPD)
Time frame: 90 days
clinical attachment level (CAL)
Time frame: 90 days
number of pockets > 4 mm
Time frame: 90 days
Full Mouth Plaque Score
Time frame: 90 days
Full Mouth Bleeding Score
Time frame: 90 days

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 3 Jun 2015.
Background: PubMed 20500539Graziani F, Cei S, La Ferla F, Vano M, Gabriele M, Tonetti M. Effects of non-surgical periodontal therapy on the glomerular filtration rate of the kidney: an exploratory trial. J Clin Periodontol. 2010 Jul;37(7):638-43. doi: 10.1111/j.1600-051X.2010.01578.x. Epub 2010 May 25.
Results publication: PubMed 20546085Graziani F, Cei S, Tonetti M, Paolantonio M, Serio R, Sammartino G, Gabriele M, D'Aiuto F. Systemic inflammation following non-surgical and surgical periodontal therapy. J Clin Periodontol. 2010 Sep;37(9):848-54. doi: 10.1111/j.1600-051X.2010.01585.x. Epub 2010 Jun 4.

Related trials for Periodontal Diseases

Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
RecruitingObservational study
Effects Of Periodontal Therapy In Patients With Inflammatory Bowel Disease
Periodontal Diseases, IBD
RecruitingObservational study
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
Immunosuppression, Periodontal Disease
Active, not recruiting
NON-SURGİCAL PERİODONTAL THERAPY WİTH L-ARGİNİNE
Periodontal Disease, Periodontal Diseases
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth

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

Questions about this trial

What is this clinical trial studying?

A study testing Scaling & Root Planing in people with Periodontal Diseases, run by University of Pisa.

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 3 inclusion and 6 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 3 Jun 2015. 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?

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?

C reactive Protein (time frame: 24 Hours). 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 NCT02460926, which also lists 2 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 3 Jun 2015; AzTrials last refreshed its copy on 31 Oct 2026.