Evaluation of Multiple Subgingival Irrigations. (POLYVIDONE)

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Unknown

Conditions

Periodontitis, Adult

Treatments

Drug: Saline Solution
Drug: Povidone-Iodine 10%

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

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

Trial contacts and locations

1

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Central trial contact

Selena Toma, Parodontologist; Selma Kessler, Dentist

Data sourced from clinicaltrials.gov

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