Evaluation of Multiple Subgingival Irrigations. (POLYVIDONE)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Unknown

Conditions: Periodontitis, Adult

Treatments: Drug: Povidone-Iodine 10%; Drug: Saline Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03432975

2017/06NOV/503

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Povidone Iodine 10%

Experimental group

Description:

The side of the mouth receiving the subgingival irrigations of povidone iodine.

Treatment:

Drug: Povidone-Iodine 10%

Sterile saline solution

Placebo Comparator group

Description:

The other side of the mouth will be irrigated with a sterile saline solution.

Treatment:

Drug: Saline Solution