Acute Phase Response & Periodontal Treatment
- Conditions
- Periodontal Diseases
- Interventions
- Procedure: Scaling & Root Planing
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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
- 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
- Arm && Interventions
Group Intervention Description Scaling & Root Planing - Full Mouth Scaling & Root Planing 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 Scaling & Root Planing - Quadrant Scaling & Root Planing 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
- Primary Outcome Measures
Name Time Method C reactive Protein 24 Hours
- Secondary Outcome Measures
Name Time Method 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
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