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NCT Number: NCT04349878

Anaysis of Phytotherapy Agent Against Periodontitis

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.

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Key information

Age range

32 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Messina

Messina, 98125, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • good condition of general health,
  • a minimum of 2 teeth for each quadrant with a 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.

Treatment and study plan

gingival crevicular fluid evaluation

Diagnostic Test

anaysis of interleukins in gingival crevicular fluid

Primary outcomes

  1. Clinical Attachment level

    Time frame: 180 days

    Analysis of reduction of clinical attachment level

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

Effect of Phytotherapy Agens in Non Surgical Periodontitis

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2020
Registry last updated
Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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