Anaysis of Phytotherapy Agent Against Periodontitis

University of Messina

Status: Completed

Conditions: Periodontitis

Treatments: Diagnostic Test: gingival crevicular fluid evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT04349878

2020-2018

Details and patient eligibility

About

In light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the decontaminant tools for the management of Periodontitis (, the aim of this study was to evaluate, at 6 months follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with periodontitis, treated by either SRP in addition to phytotherapeutic drug or SRP alone.

Full description

This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2008. The local ethical committee of the University of Messina approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent 34 patients, 18 men and 16 women, aged 27 to 65 (mean age 44.2) were assessed for eligibility . In all subjects, subgingival plaque was acquired from 4 separate proximal sites at 365 days after therapy.

The Gingival Crevicular Fluid (GCF) was gathered, at the same time from other four different non-contiguous interproximal sites using filter paper strips‡ as previously described. The levels of IL-1β, IL-10 and TNF-α were recognized by conventional enzyme-linked immunosorbent assay using an equation with software using a five polynomial parameter. Each selected subject underwent randomly, without anaesthesia, at the same time and after recording periodontal parameters, the two following treatments: in one, were treated as conventional Scaling and Root Planing (SRP) + phytotherapeutic drug (Neuridase), while the other group were treated as conventional SRP alone

Enrollment: 34 patients

Sex: All

Ages: 32 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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,
6. use of mouthwash containing antimicrobials during the previous 3 months,
7. no use of hormonal contraceptives,
8. medication by anti-inflammatory and immunosuppressive drugs,
9. previous history of hard-drinking,
10. smoking,
11. class II and III tooth mobility.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

scaling and root planing alone

Treatment:

Diagnostic Test: gingival crevicular fluid evaluation

phytotherapeutic

Active Comparator group

Description:

scaling and root planing plus phytotherapeutic agent

Treatment:

Diagnostic Test: gingival crevicular fluid evaluation