Back to resultsEffectiveness of Periodontal Therapy on Periodontal Bacteria
Primary Purpose
Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Full mouth or quadrant SRP
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Presence of at least 15 teeth
CP with a minimum of 40% of sites with a clinical attachment level (CAL)
≥2mm and probing depth (PD) ≥4mm;
- Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
- Presence of ≥40% sites with bleeding on probing (BOP)
Exclusion Criteria:
- Intake of contraceptives
- Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
- Status of pregnancy or lactation
- Previous history of excessive drinking
- Allergy to local anaesthetic
- Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
Sites / Locations
- University of Catania
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Periodontitis quadrant Scaling root planing
Periodontitis full mouth scaling root planing
Arm Description
Patients undergo non surgical quadrant scaling and root planing performed per quadrant
Patients undergo non surgical full mouth scaling and root planing
Outcomes
Primary Outcome Measures
Clinical attachment level
evaluation of changes in clinical attachment level
Secondary Outcome Measures
Full Information
NCT ID
NCT04735692
First Posted
January 29, 2021
Last Updated
December 13, 2022
Sponsor
University of Catania
1. Study Identification
Unique Protocol Identification Number
NCT04735692
Brief Title
Effectiveness of Periodontal Therapy on Periodontal Bacteria
Official Title
Impact of Periodontal Bacteria on the Effectiveness of Periodontal Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2021 (Actual)
Primary Completion Date
December 5, 2022 (Actual)
Study Completion Date
December 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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 88 patients, aged 27 to 65 (mean age 57) 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
Model Description
Patients undergo non-surgical quadrant scaling and root planing
Masking
ParticipantInvestigator
Masking Description
Both participants and clinicians were blinded to group and treatment assignment
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Periodontitis quadrant Scaling root planing
Arm Type
Placebo Comparator
Arm Description
Patients undergo non surgical quadrant scaling and root planing performed per quadrant
Arm Title
Periodontitis full mouth scaling root planing
Arm Type
Active Comparator
Arm Description
Patients undergo non surgical full mouth scaling and root planing
Intervention Type
Other
Intervention Name(s)
Full mouth or quadrant SRP
Intervention Description
Full mouth or quadrant SRP
Primary Outcome Measure Information:
Title
Clinical attachment level
Description
evaluation of changes in clinical attachment level
Time Frame
1-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Presence of at least 15 teeth
CP with a minimum of 40% of sites with a clinical attachment level (CAL)
≥2mm and probing depth (PD) ≥4mm;
Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
Presence of ≥40% sites with bleeding on probing (BOP)
Exclusion Criteria:
Intake of contraceptives
Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
Status of pregnancy or lactation
Previous history of excessive drinking
Allergy to local anaesthetic
Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola
Organizational Affiliation
Università degli Studi di Catania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Catania
City
Catania
State/Province
CT
ZIP/Postal Code
95124
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
all collected IPD, all IPD that underlie results in a publication
Learn more about this trial
Effectiveness of Periodontal Therapy on Periodontal Bacteria
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