Acute Phase Response & Periodontal Treatment

NCT ID: NCT02460926

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-10-31

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.

Conditions

Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Scaling & Root Planing - Quadrant

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

Group Type: EXPERIMENTAL

Scaling & Root Planing

Intervention Type: PROCEDURE

It consists in the non-surgical debridement of the sub gingival area affected by periodontal disease

Scaling & Root Planing - Full Mouth

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

Group Type: EXPERIMENTAL

Scaling & Root Planing

Intervention Type: PROCEDURE

It consists in the non-surgical debridement of the sub gingival area affected by periodontal disease

Interventions

Scaling & Root Planing

It consists in the non-surgical debridement of the sub gingival area affected by periodontal disease

Intervention Type: PROCEDURE

Other Intervention Names

SRP

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastman Dental Insitute and Hospital

OTHER

Sponsor Role: collaborator

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Filippo Graziani, DDS MClinDent PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Filippo Graziani, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pisa

References

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.

Reference Type: BACKGROUND

PMID: 20500539 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20546085 (View on PubMed)

Other Identifiers

3399/11

Identifier Type: -

Identifier Source: org_study_id