Evaluation of Multiple Subgingival Irrigations.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2019-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Periodontitis, Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

20 patients (=40 half-mouth); 20 half-mouth per group

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Povidone Iodine 10%

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

Group Type EXPERIMENTAL

Povidone-Iodine 10%

Intervention Type DRUG

The side of the mouth receiving the subgingival irrigations of povidone iodine 10% (test group)

Sterile saline solution

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

Group Type PLACEBO_COMPARATOR

Saline Solution

Intervention Type DRUG

The other side of the mouth will be irrigated with a sterile saline solution (control group)

Interventions

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Povidone-Iodine 10%

The side of the mouth receiving the subgingival irrigations of povidone iodine 10% (test group)

Intervention Type DRUG

Saline Solution

The other side of the mouth will be irrigated with a sterile saline solution (control group)

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No