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Acute Phase Response & Periodontal Treatment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02460926
Acronym
PERIOSYST-1
Enrollment
38
Registered
2015-06-03
Start date
2012-05-31
Completion date
2014-10-31
Last updated
2015-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases

Keywords

Scaling and root planning, C-reactive protein

Brief summary

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.

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.

Interventions

It consists in the non-surgical debridement of the sub gingival area affected by periodontal disease

Sponsors

Eastman Dental Insitute and Hospital
CollaboratorOTHER
University of Pisa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
C reactive Protein24 Hours

Secondary

MeasureTime frameDescription
Tumor Necrosis Factor - alpha24 Hours, 7 days, 90 days
Interleukin - 624 Hours, 7 days, 90 days
periodontal pocket depth (PPD)90 daysmean in mm
C reactive Protein7 days, 90 days
number of pockets > 4 mm90 daysnumber of pockets \> 4 mm
Full Mouth Plaque Score90 dayspresence/absence of dental plaque in percentual values
Full Mouth Bleeding Score90 dayspresence/absence of sites bleeding on probing in percentual values
clinical attachment level (CAL)90 daysmean in mm

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026