Acute Phase Response & Periodontal Treatment

Not Applicable

Completed

• Conditions: Periodontal Diseases

• Registration Number: NCT02460926
• Lead Sponsor: University of Pisa

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.

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2013-10
• Study Completion: 2014-10
• Status Verified: 2015-05
• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-05-30
• Last Update Submitted: 2015-05-30
• Study First Posted: 2015-06-03
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
C reactive Protein	24 Hours

Secondary Outcome Measures

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