Evaluation of Multiple Subgingival Irrigations. (POLYVIDONE)
Primary Purpose
Periodontitis, Adult
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Povidone-Iodine 10%
Saline Solution
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis, Adult
Eligibility Criteria
Inclusion Criteria:
- ≥ 30 years of age
- At least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction)
- Any history of periodontal treatment in the previous 6 months
- No removable prosthesis
- A minimum of 6 teeth with at least one site each with periodontal probing depth (PPD) and clinical attachment level (CAL) ≥5 mm
- At least 30% of the sites with PPD and CAL ≥4 mm and bleeding on probing (BOP)
Exclusion Criteria:
- Any sensitivity or allergy to any of the products that will be used in the study
- Thyroid dysfunction
- Systemic disease (ASA II or more)
- Need for antibiotic pre-medication for routine dental therapy
- Antibiotic therapy in the previous 3 months
- Pregnancy and breastfeeding
- Current smokers (more than 5 cigarettes a day)
Sites / Locations
- Cliniques Universitaires Saint-LucRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Povidone Iodine 10%
Sterile saline solution
Arm Description
The side of the mouth receiving the subgingival irrigations of povidone iodine.
The other side of the mouth will be irrigated with a sterile saline solution.
Outcomes
Primary Outcome Measures
Percentage of subjects reaching ≤ 4 mm in periodontal sites with PPD ≥ 5 mm
The primary objective of this study is to determine the effect of PVI on periodontal probing depth (PPD).
Secondary Outcome Measures
Full Information
NCT ID
NCT03432975
First Posted
February 8, 2018
Last Updated
July 12, 2019
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT03432975
Brief Title
Evaluation of Multiple Subgingival Irrigations.
Acronym
POLYVIDONE
Official Title
Evaluation of Multiple Subgingival Irrigations With 10% Povidone Iodine After Scaling and Root Planing : a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
August 31, 2019 (Anticipated)
Study Completion Date
August 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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
The study will be conducted at the Department of Periodontology, Cliniques universitaires Saint Luc. Patients diagnosed with Generalized Chronic Periodontitis (GChP) based on the current classification of the American Academy of Periodontology will be included. Detailed medical, periodontal and dental history will be obtained. Those who will fulfill the inclusion/exclusion criteria will be invited to participate in the study.
Detailed Description
The study will be conducted at the Department of Periodontology, Cliniques universitaires Saint Luc. The patients will be informed in detail of the nature and course of study, and will sign informed consent prior to engagement in the study. Patients diagnosed with GChP based on the current classification of the American Academy of Periodontology will be included. Detailed medical, periodontal and dental history will be obtained. Those who will fulfill the inclusion/exclusion criteria will be invited to participate in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Adult
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
20 patients (=40 half-mouth); 20 half-mouth per group
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Povidone Iodine 10%
Arm Type
Experimental
Arm Description
The side of the mouth receiving the subgingival irrigations of povidone iodine.
Arm Title
Sterile saline solution
Arm Type
Placebo Comparator
Arm Description
The other side of the mouth will be irrigated with a sterile saline solution.
Intervention Type
Drug
Intervention Name(s)
Povidone-Iodine 10%
Intervention Description
The side of the mouth receiving the subgingival irrigations of povidone iodine 10% (test group)
Intervention Type
Drug
Intervention Name(s)
Saline Solution
Intervention Description
The other side of the mouth will be irrigated with a sterile saline solution (control group)
Primary Outcome Measure Information:
Title
Percentage of subjects reaching ≤ 4 mm in periodontal sites with PPD ≥ 5 mm
Description
The primary objective of this study is to determine the effect of PVI on periodontal probing depth (PPD).
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 30 years of age
At least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction)
Any history of periodontal treatment in the previous 6 months
No removable prosthesis
A minimum of 6 teeth with at least one site each with periodontal probing depth (PPD) and clinical attachment level (CAL) ≥5 mm
At least 30% of the sites with PPD and CAL ≥4 mm and bleeding on probing (BOP)
Exclusion Criteria:
Any sensitivity or allergy to any of the products that will be used in the study
Thyroid dysfunction
Systemic disease (ASA II or more)
Need for antibiotic pre-medication for routine dental therapy
Antibiotic therapy in the previous 3 months
Pregnancy and breastfeeding
Current smokers (more than 5 cigarettes a day)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Selena Toma, Parodontologist
Phone
00322764
Ext
5714
Email
selena.toma@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Selma Kessler, Dentist
Phone
00322764
Ext
5714
Email
selma.kessler@uclouvain.be
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selena Toma, Parodontologist
Phone
00322764
Ext
5714
Email
selena.toma@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Selma Kessler, Dentist
Phone
00322764
Ext
5714
Email
selma.kessler@uclouvain.be
12. IPD Sharing Statement
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Evaluation of Multiple Subgingival Irrigations.
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