Evaluation of Multiple Subgingival Irrigations.

Periodontitis, Adult Clinical Trial

— POLYVIDONE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03432975
• Other study ID #: 2017/06NOV/503
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: July 2019
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Selena Toma, Parodontologist
• Phone: 00322764
• Email: selena.toma[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis
• Periodontitis, Adult

Intervention

Drug:
• Povidone-Iodine 10%
The side of the mouth receiving the subgingival irrigations of povidone iodine 10% (test group)
• Saline Solution
The other side of the mouth will be irrigated with a sterile saline solution (control group)

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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