Evaluation of Multiple Subgingival Irrigations.

NCT03432975 | Unknown

• 1 other identifier: 2017/06NOV/503
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis, Adult

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Povidone Iodine 10%

EXPERIMENTAL

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

Drug: Povidone-Iodine 10%

Sterile saline solution

PLACEBO COMPARATOR

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

Drug: Saline Solution

Interventions

Povidone-Iodine 10% DRUG

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

Povidone Iodine 10%

Saline Solution DRUG

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

Sterile saline solution

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Selena Toma, Parodontologist

CONTACT

00322764; selena.toma@uclouvain.be

Selma Kessler, Dentist

CONTACT

00322764; selma.kessler@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 14, 2018
• Study Start: December 18, 2017
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

BE (1)