Evaluation of multiple subgingival irrigations with 10% povidone iodine after scaling and root planing

Phase 1

• Conditions: Periodontitis is characterized by alveolar bone loss induced by the host immune response to bacterial insult. Because povidone iodine is known to be a powerful antiseptic, there is biologic rationale to suspect that PVI subgingival irrigations after SRP could positively affect the periodontium; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]

• Registration Number: EUCTR2017-004493-34-BE
• Lead Sponsor: Cliniques universitaires Saint-Luc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-08
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

All subjects who are in good general health (ASA I) and were diagnosed with GChP based on the current classification of the American Academy of Periodontology will be included:
·= 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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to evaluate the clinical outcomes of multiple subgingival irrigations of 10% Povidone Iodine (PVI) as adjunct to scaling and root planing (SRP) in the treatment of severe generalized chronic periodontitis (GChP);Secondary Objective: The objective of this study is to evaluate the clinical outcomes of multiple subgingival irrigations of 10% Povidone Iodine (PVI) as adjunct to scaling and root planing (SRP) in the treatment of severe generalized chronic periodontitis (GChP);Primary end point(s): The primary objective of this study is to determine the effect of PVI on periodontal probing depth (PPD).<br>;Timepoint(s) of evaluation of this end point: up to 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary objectives are to determine the effect of PVI on parameters associated with periodontal health such as clinical attachment level (CAL) and bleeding on probing (BOP);Timepoint(s) of evaluation of this end point: up to 6 months