Evaluation of Multiple Subgingival Irrigations.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Multiple Subgingival Irrigations With 10% Povidone Iodine After Scaling and Root Planing : a Randomized Clinical Trial

Conditions
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Periodontitis, Adult

Intervention / Treatment
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* Drug: Povidone-Iodine 10%
* Drug: Saline Solution


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 20 patients (=40 half-mouth); 20 half-mouth per group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Povidone Iodine 10%<br>The side of the mouth receiving the subgingival irrigations of povidone iodine. | Drug: Povidone-Iodine 10%<br>* The side of the mouth receiving the subgingival irrigations of povidone iodine 10% (test group)<br>|
| Placebo Comparator: Sterile saline solution<br>The other side of the mouth will be irrigated with a sterile saline solution. | Drug: Saline Solution<br>* The other side of the mouth will be irrigated with a sterile saline solution (control group)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | up to 6 months |