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CompletedNCT04349878Updated Apr 20, 2020

Anaysis of Phytotherapy Agent Against Periodontitis

An interventional study of gingival crevicular fluid evaluation in Periodontitis, sponsored by University of Messina. Completed at 1 site in Italy. Open to participants aged 32 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-20.

Sponsored by University of Messina · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Sep 2019, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
32 Years to 70 Years
Sex
All
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Study summary

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.

Read the detailed 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

02

Conditions studied

  • Periodontitis

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03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 34 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.

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Lead sponsor

University of Messina is the lead sponsor of 53 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
32 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
34 participants (actual)

Study arms

  • Placebo comparator
    Control

    scaling and root planing alone

    Diagnostic Test: gingival crevicular fluid evaluation

  • Active comparator
    phytotherapeutic

    scaling and root planing plus phytotherapeutic agent

    Diagnostic Test: gingival crevicular fluid evaluation

Interventions

  • Diagnostic testgingival crevicular fluid evaluation

    anaysis of interleukins in gingival crevicular fluid

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What researchers measure

Primary outcomes

  1. Clinical Attachment level

    Analysis of reduction of clinical attachment level

    Time frame: 180 days

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Study locations

1 site
  • University of Messina
    Messina, 98125, Italy
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References and documents

Individual participant data

Plan to share: Yes — Sharing inflammatory results

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04349878
Lead sponsor
University of Messina
Responsible party
Gaetano Isola, DDS, PhD (Assistant professor, University of Messina) — Principal investigator
First posted
Apr 16, 2020
Start date
Sep 1, 2019
Primary completion
Mar 1, 2020
Completion
Mar 5, 2020
Last update
Apr 20, 2020

Study contacts

Gatano Isola
study chair · University of Messina

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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