Periodontitis
Conditions
Keywords
Periodontitis, serum markers, CRP, NT-proBNP
Brief summary
In light of the controversy that are already approved but that however still exists regarding the efficacy and influence the management of Periodontitis, the aim of this study was to evaluates, at 6-months follow-up, the post-treatment clinical and serum parameters in patients with periodontitis, treated by either Intensive scaling and root planing (SRP) treatment versus conventional oral hygiene treatment on serum CRP and NT-proBNP levels. The null hypothesis to invalidate was that there were no variations, in relation to clinical and serum CRP and NT-proBNP.
Detailed description
This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2016. The local ethical committee approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent. Subjects with a diagnosis of periodontitis were enrolled in this clinical trial. The inclusion criteria were: 1) good condition of general health, 2) a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm, 3) no involvement of the furcation, 4) a minimum of a six teeth per quadrant, respectively. The exclusion criteria were: 1) periodontal therapy during the last 12 months, 2) assumption of antibiotics during the last 6 months, 3) pregnancy, 4) any systemic condition which might affect the effects of the study treatment, 5) previous or current radiation or immunosuppressive therapies, 5) use of mouthwash containing antimicrobials during the previous 3 months, 6) no use of hormonal contraceptives, 7) medication by anti-inflammatory and immunosuppressive drugs, 8) previous history of hard-drinking, 9) smoking, 10) class II and III tooth mobility. Patients randomly undergo to full mouth SRP (test group) or oral hygiene treatment (control group)
Interventions
DIAGNOSTIC_TESTEvaluation of serum CRP and NT-proBNP
All patients were evaluated to 6-months post-treatment reduction of serum CRP and NT-proBNP
Sponsors
University of Catania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Though sealed envelopes both clinicians and patients were masked to the selected treatment
Intervention model description
Each selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Scaling and Root Planing (SRP), while the control group undergo to standard oral hygiene treatment.
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* good condition of general health * a minimum of 2 teeth for each quadrant with * Pocket Depth (PD) ranging from 4-6 mm * no involvement of the furcation * a minimum of a six teeth per quadrant, respectively
Exclusion criteria
* periodontal therapy during the last 12 months * assumption of antibiotics during the last 6 months * pregnancy * any systemic condition which might affect the effects of the study treatment * previous or current radiation or immunosuppressive therapies * use of mouthwash containing antimicrobials during the previous 3 months * no use of hormonal contraceptives * medication by anti-inflammatory and immunosuppressive drugs * previous history of hard drinking * smoking * class II and III tooth mobility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Clinical Attachment Level | 6-months | Change of periodontal Clinical Attachment Level |
Countries
Italy
Outcome results
None listed