Evaluation of Multiple Subgingival Irrigations.

Not Applicable

• Conditions: Periodontitis, Adult
• Interventions: Drug: Povidone-Iodine 10%; Drug: Saline Solution

• Registration Number: NCT03432975
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Timeline

• Study Start: 2017-12-18
• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-14
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-12
• Last Update Posted: 2019-07-15
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Povidone Iodine 10%	Povidone-Iodine 10%	The side of the mouth receiving the subgingival irrigations of povidone iodine.
Sterile saline solution	Saline Solution	The other side of the mouth will be irrigated with a sterile saline solution.

Primary Outcome Measures

Name	Time	Method
Percentage of subjects reaching ≤ 4 mm in periodontal sites with PPD ≥ 5 mm	up to 6 months	The primary objective of this study is to determine the effect of PVI on periodontal probing depth (PPD).

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium