Evaluation of Multiple Subgingival Irrigations. (POLYVIDONE)

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

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.

Study Overview

• Status: Unknown
• Conditions: Periodontitis, Adult
• Intervention / Treatment: Drug: Povidone-Iodine 10%; Drug: Saline Solution

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Selena Toma, Parodontologist; Phone Number: 5714 00322764; Email: selena.toma@uclouvain.be
• Study Contact Backup: Name: Selma Kessler, Dentist; Phone Number: 5714 00322764; Email: selma.kessler@uclouvain.be

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-Luc
    • Contact: Selena Toma, Parodontologist; Phone Number: 5714 00322764; Email: selena.toma@uclouvain.be
    • Contact: Selma Kessler, Dentist; Phone Number: 5714 00322764; Email: selma.kessler@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Anticipated): August 31, 2019
• Study Completion (Anticipated): August 31, 2019

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: 2017/06NOV/503

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No