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Anaysis of Phytotherapy Agent Against Periodontitis

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
gingival crevicular fluid evaluation
Sponsored by
University of Messina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Periodontitis

Eligibility Criteria

32 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • University of Messina

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

phytotherapeutic

Arm Description

scaling and root planing alone

scaling and root planing plus phytotherapeutic agent

Outcomes

Primary Outcome Measures

Clinical Attachment level
Analysis of reduction of clinical attachment level

Secondary Outcome Measures

Full Information

First Posted
April 13, 2020
Last Updated
April 16, 2020
Sponsor
University of Messina
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1. Study Identification

Unique Protocol Identification Number
NCT04349878
Brief Title
Anaysis of Phytotherapy Agent Against Periodontitis
Official Title
Effect of Phytotherapy Agens in Non Surgical Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Messina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
scaling and root planing alone
Arm Title
phytotherapeutic
Arm Type
Active Comparator
Arm Description
scaling and root planing plus phytotherapeutic agent
Intervention Type
Diagnostic Test
Intervention Name(s)
gingival crevicular fluid evaluation
Intervention Description
anaysis of interleukins in gingival crevicular fluid
Primary Outcome Measure Information:
Title
Clinical Attachment level
Description
Analysis of reduction of clinical attachment level
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gatano Isola
Organizational Affiliation
University of Messina
Official's Role
Study Chair
Facility Information:
Facility Name
University of Messina
City
Messina
ZIP/Postal Code
98125
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Sharing inflammatory results
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
University website and pubmed

Learn more about this trial

Anaysis of Phytotherapy Agent Against Periodontitis

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