Anaysis of Phytotherapy Agent Against Periodontitis

• Sponsor: University of Messina (Other)
• Overall Status: Completed
• CT.gov ID: NCT04349878
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.1
• Patients Per Site Per Month: 5.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis	Diagnostic Test: gingival crevicular fluid evaluation	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Effect of Phytotherapy Agens in Non Surgical Periodontitis
• Actual Study Start Date: Sep 1, 2019
• Actual Primary Completion Date: Mar 1, 2020
• Actual Study Completion Date: Mar 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control scaling and root planing alone	Diagnostic Test: gingival crevicular fluid evaluation; anaysis of interleukins in gingival crevicular fluid
Active Comparator: phytotherapeutic scaling and root planing plus phytotherapeutic agent	Diagnostic Test: gingival crevicular fluid evaluation; anaysis of interleukins in gingival crevicular fluid

Outcome Measures

Primary Outcome Measures

1. Clinical Attachment level [180 days]

   Analysis of reduction of clinical attachment level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 32 Years to 70 Years
• Sexes Eligible for Study: 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Messina	Messina		Italy	98125

Sponsors and Collaborators

• University of Messina

Investigators

• Study Chair: Gatano Isola, University of Messina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gaetano Isola, DDS, PhD, Assistant professor, University of Messina
• ClinicalTrials.gov Identifier: NCT04349878
• Other Study ID Numbers: 2020-2018
• First Posted: Apr 16, 2020
• Last Update Posted: Apr 20, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Periodontitis

Study Results

No Results Posted as of Apr 20, 2020