Status:
COMPLETED
Oral Hygiene and Systemic Inflammation (Perio-Hygiene 1.0)
Lead Sponsor:
University of Pisa
Conditions:
Gingivitis
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate the impact of oral hygiene changes (drastic plaque and gingival inflammation reduction) on markers of systemic inflammation and indicators of oral health relate...
Detailed Description
This study is a single-center, 2 arms, randomized parallel group double-blind clinical trial with one month follow-up, involving patients with no conditions capable of alteration of the systemic infla...
Eligibility Criteria
Inclusion
- male or female, 18 to 79 of age, of any race/ethnicity;
- presence of at least 20 teeth;
- ≤ 2 untreated dental caries;
- presence of relevant plaque accumulation as shown by Full Mouth Plaque Scores (FMBS) \>50%.
- presence of relevant periodontal/gingival inflammation as shown by FMBS \> 35%
Exclusion
- • pregnancy and breast feeding;
- patients undergoing pharmacological treatment capable of reducing CRP such as statins or chronic anti-inflammatory treatment,
- current or past (≤ 30 days) systemic or local antibiotic therapy;
- heavy smokers (over 20 cigarettes per day or pipe or cigar);
- patients undergoing orthodontic treatment;
- patients not capable to comply with given instruction or administrative issues related to the study
- dental or periodontal conditions (e.g., deep caries, periodontal abscess) requiring urgent treatment
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2021
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03848351
Start Date
April 1 2019
End Date
May 4 2021
Last Update
November 7 2022
Active Locations (1)
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1
University Hospital of Pisa
Pisa, Italy, 56126