Acute Phase Response & Periodontal Treatment (PERIOSYST-1)

University of Pisa

Status: Completed

Conditions: Periodontal Diseases

Treatments: Procedure: Scaling & Root Planing

Study type: Interventional

Funder types: Other

Identifiers

NCT02460926

3399/11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Scaling & Root Planing - Quadrant

Experimental group

Description:

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

Treatment:

Procedure: Scaling & Root Planing

Scaling & Root Planing - Full Mouth

Experimental group

Description:

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

Treatment:

Procedure: Scaling & Root Planing