An interventional study of Scaling & Root Planing in Periodontal Diseases, sponsored by University of Pisa. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-06-03.
Sponsored by University of Pisa · Not applicable, Interventional, and Treatment
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.
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.
830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.
This study's enrollment of 38 is below the median of 45 across 530 interventional studies indexed under Periodontal Diseases.
Browse Periodontal Diseases studies →University of Pisa is the lead sponsor of 111 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
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
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
Also known as: SRP
C reactive Protein
Time frame: 24 Hours
C reactive Protein
Time frame: 7 days, 90 days
Tumor Necrosis Factor - alpha
Time frame: 24 Hours, 7 days, 90 days
Interleukin - 6
Time frame: 24 Hours, 7 days, 90 days
periodontal pocket depth (PPD)
mean in mm
Time frame: 90 days
periodontal pocket depth (PPD)
mean in site \> 4mm
Time frame: 90 days
clinical attachment level (CAL)
mean in mm
Time frame: 90 days
number of pockets > 4 mm
number of pockets \> 4 mm
Time frame: 90 days
Full Mouth Plaque Score
presence/absence of dental plaque in percentual values
Time frame: 90 days
Full Mouth Bleeding Score
presence/absence of sites bleeding on probing in percentual values
Time frame: 90 days
No study locations are listed for this record.
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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University of Pisa