Acute Phase Response & Periodontal Treatment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Procedure: Scaling & Root Planing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scaling and root planning, C-reactive protein