Acute Phase Response & Periodontal Treatment
PERIOSYST-1
Acute Phase Response Following Full Mouth Versus Quadrant Non-Surgical Periodontal Treatment. A Randomized Clinical Trial
1 other identifier
interventional
38
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2012
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 28, 2015
CompletedFirst Posted
Study publicly available on registry
June 3, 2015
CompletedJune 3, 2015
May 1, 2015
1.4 years
May 28, 2015
May 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
C reactive Protein
24 Hours
Secondary Outcomes (9)
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)
90 days
periodontal pocket depth (PPD)
90 days
- +4 more secondary outcomes
Study Arms (2)
Scaling & Root Planing - Quadrant
EXPERIMENTALPeriodontal 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
Scaling & Root Planing - Full Mouth
EXPERIMENTALPeriodontal 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
Interventions
It consists in the non-surgical debridement of the sub gingival area affected by periodontal disease
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pisalead
- Eastman Dental Insitute and Hospitalcollaborator
Related 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.
PMID: 20500539BACKGROUNDGraziani 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. Epub 2010 Jun 4.
PMID: 20546085RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Filippo Graziani, DDS, PhD
University of Pisa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 28, 2015
First Posted
June 3, 2015
Study Start
May 1, 2012
Primary Completion
October 1, 2013
Study Completion
October 1, 2014
Last Updated
June 3, 2015
Record last verified: 2015-05