Impact of Periodontal Bacteria at Baseline on the Effectiveness of Periodontal Therapy
1 other identifier
interventional
102
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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
Typical duration 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
June 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2020
CompletedFirst Submitted
Initial submission to the registry
May 6, 2020
CompletedFirst Posted
Study publicly available on registry
May 11, 2020
CompletedMay 11, 2020
May 1, 2020
1.8 years
May 6, 2020
May 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Attachment level
Analysis of reduction of clinical attachment level
180 days
Study Arms (2)
Periodontitis quadrant
PLACEBO COMPARATORPatients undergo non surgical quadrant scaling and root planing
Periodontitis full mouth
ACTIVE COMPARATORPatients undergo non surgical full mouth scaling and root planing
Interventions
Full mouth or quadrant SRP
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, 98100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gaetano Isola
University of Messina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
May 6, 2020
First Posted
May 11, 2020
Study Start
June 5, 2018
Primary Completion
March 5, 2020
Study Completion
March 15, 2020
Last Updated
May 11, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 1 year
- Access Criteria
- University website and pubmed
Sharing inflammatory results