Clinical trial NCT02460926: Acute Phase Response & Periodontal Treatment
Official title: Acute Phase Response Following Full Mouth Versus Quadrant Non-Surgical Periodontal Treatment. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: Scaling and root planning
C-reactive protein
Lead sponsor: University of Pisa
Sponsor class: OTHER
Collaborators: name: Eastman Dental Insitute and Hospital
First posted: 2015-06-03
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: C reactive Protein
timeFrame: 24 Hours
Secondary outcomes:
measure: C reactive Protein
timeFrame: 7 days, 90 days
measure: Tumor Necrosis Factor - alpha
timeFrame: 24 Hours, 7 days, 90 days
measure: Interleukin - 6
timeFrame: 24 Hours, 7 days, 90 days
measure: periodontal pocket depth (PPD)
timeFrame: 90 days
measure: periodontal pocket depth (PPD)
timeFrame: 90 days
measure: clinical attachment level (CAL)
timeFrame: 90 days
measure: number of pockets > 4 mm
timeFrame: 90 days
measure: Full Mouth Plaque Score
timeFrame: 90 days
measure: Full Mouth Bleeding Score
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Pisa
name: Filippo Graziani, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. Epub 2010 Jun 4.