Anaysis of Phytotherapy Agent Against Periodontitis
Effect of Phytotherapy Agens in Non Surgical Periodontitis
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2020
CompletedFirst Submitted
Initial submission to the registry
April 13, 2020
CompletedFirst Posted
Study publicly available on registry
April 16, 2020
CompletedApril 20, 2020
April 1, 2020
6 months
April 13, 2020
April 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Attachment level
Analysis of reduction of clinical attachment level
180 days
Study Arms (2)
Control
PLACEBO COMPARATORscaling and root planing alone
phytotherapeutic
ACTIVE COMPARATORscaling and root planing plus phytotherapeutic agent
Interventions
anaysis of interleukins in gingival crevicular fluid
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Messina
Messina, 98125, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gatano Isola
University of Messina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
April 13, 2020
First Posted
April 16, 2020
Study Start
September 1, 2019
Primary Completion
March 1, 2020
Study Completion
March 5, 2020
Last Updated
April 20, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 1 year
- Access Criteria
- University website and pubmed
Sharing inflammatory results