- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04382261
Impact of Periodontal Bacteria at Baseline on the Effectiveness of Periodontal Therapy
May 6, 2020 updated by: Gaetano Isola, DDS, PhD, University of Messina
Impact of Periodontal Bacteria at Baseline on the Effectiveness of Periodontal Therapy Outcomes in Patients With Periodontitis: A Prospective Clinical and Microbial Study
In light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the protocols 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 full mouth scaling or quadrant scaling
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 102 patients, , 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 180 days after therapy.
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Messina, Italy, 98100
- University of Messina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Periodontitis quadrant
Patients undergo non surgical quadrant scaling and root planing
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Full mouth or quadrant SRP
|
Active Comparator: Periodontitis full mouth
Patients undergo non surgical full mouth scaling and root planing
|
Full mouth or quadrant SRP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Attachment level
Time Frame: 180 days
|
Analysis of reduction of clinical attachment level
|
180 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Gaetano Isola, University of Messina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2018
Primary Completion (Actual)
March 5, 2020
Study Completion (Actual)
March 15, 2020
Study Registration Dates
First Submitted
May 6, 2020
First Submitted That Met QC Criteria
May 6, 2020
First Posted (Actual)
May 11, 2020
Study Record Updates
Last Update Posted (Actual)
May 11, 2020
Last Update Submitted That Met QC Criteria
May 6, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-2018-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Sharing inflammatory results
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
University website and pubmed
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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