Acute Phase Response & Periodontal Treatment

Periodontal Diseases Clinical Trial

— PERIOSYST-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460926
• Other study ID #: 3399/11
• Status: Completed
• Phase: N/A
• First received: May 28, 2015
• Last updated: May 30, 2015
• Start date: May 2012
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute-Phase Reaction
• Gingival Diseases
• Periodontal Diseases

Intervention

Procedure:
• Scaling & Root Planing
It consists in the non-surgical debridement of the sub gingival area affected by periodontal disease

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Pisa	Eastman Dental Insitute and Hospital

References & Publications (2)

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. — View Citation

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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C reactive Protein		24 Hours	No
Secondary	C reactive Protein		7 days, 90 days	No
Secondary	Tumor Necrosis Factor - alpha		24 Hours, 7 days, 90 days	No
Secondary	Interleukin - 6		24 Hours, 7 days, 90 days	No
Secondary	periodontal pocket depth (PPD)	mean in mm	90 days	No
Secondary	periodontal pocket depth (PPD)	mean in site > 4mm	90 days	No
Secondary	clinical attachment level (CAL)	mean in mm	90 days	No
Secondary	number of pockets > 4 mm	number of pockets > 4 mm	90 days	No
Secondary	Full Mouth Plaque Score	presence/absence of dental plaque in percentual values	90 days	No
Secondary	Full Mouth Bleeding Score	presence/absence of sites bleeding on probing in percentual values	90 days	No