Acute Phase Response & Periodontal Treatment (PERIOSYST-1)

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Procedure: Scaling & Root Planing

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scaling & Root Planing - Quadrant; 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	Procedure: Scaling & Root Planing; It consists in the non-surgical debridement of the sub gingival area affected by periodontal disease; Other Names: SRP
Experimental: Scaling & Root Planing - Full Mouth; 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	Procedure: Scaling & Root Planing; It consists in the non-surgical debridement of the sub gingival area affected by periodontal disease; Other Names: SRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
C reactive Protein	24 Hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Pisa
• Collaborators: Eastman Dental Insitute and Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: May 28, 2015
• First Submitted That Met QC Criteria: May 30, 2015
• First Posted (Estimate): June 3, 2015

Study Record Updates

• Last Update Posted (Estimate): June 3, 2015
• Last Update Submitted That Met QC Criteria: May 30, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: C-reactive protein; Scaling and root planning
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases; Acute-Phase Reaction
• Other Study ID Numbers: 3399/11