Back to resultsImpact of Periodontal Bacteria at Baseline on the Effectiveness of Periodontal Therapy
Primary Purpose
Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Scaling and root planing
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
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.
Sites / Locations
- University of Messina
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Periodontitis quadrant
Periodontitis full mouth
Arm Description
Patients undergo non surgical quadrant scaling and root planing
Patients undergo non surgical full mouth scaling and root planing
Outcomes
Primary Outcome Measures
Clinical Attachment level
Analysis of reduction of clinical attachment level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04382261
Brief Title
Impact of Periodontal Bacteria at Baseline on the Effectiveness of Periodontal Therapy
Official Title
Impact of Periodontal Bacteria at Baseline on the Effectiveness of Periodontal Therapy Outcomes in Patients With Periodontitis: A Prospective Clinical and Microbial Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 5, 2018 (Actual)
Primary Completion Date
March 5, 2020 (Actual)
Study Completion Date
March 15, 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 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
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.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Periodontitis quadrant
Arm Type
Placebo Comparator
Arm Description
Patients undergo non surgical quadrant scaling and root planing
Arm Title
Periodontitis full mouth
Arm Type
Active Comparator
Arm Description
Patients undergo non surgical full mouth scaling and root planing
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing
Intervention Description
Full mouth or quadrant SRP
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
30 Years
Maximum Age & Unit of Time
65 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
Gaetano Isola
Organizational Affiliation
University of Messina
Official's Role
Study Chair
Facility Information:
Facility Name
University of Messina
City
Messina
ZIP/Postal Code
98100
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
Impact of Periodontal Bacteria at Baseline on the Effectiveness of Periodontal Therapy
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