Evaluation of Multiple Subgingival Irrigations. | NCT03432975

Studies
Evaluation of Multiple Subgingival Irrigations.

NCT03432975

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Unknown status

Last Update Posted

Jul 15, 2019Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Periodontitis, Adult

Interventions

Povidone-Iodine 10%
Saline Solution

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 18, 2017Actual

Primary Completion Date

Aug 31, 2019Estimated

Completion Date

Aug 31, 2019Estimated

First Submitted Date

Feb 8, 2018

First Submission Date that Met QC Criteria

Feb 8, 2018

First Posted Date

Feb 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2019

Last Update Posted Date

Jul 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Povidone-Iodine 10%	Drug	The side of the mouth receiving the subgingival irrigations of povidone iodine 10% (test group)	Povidone Iodine 10%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Selena Toma, Parodontologist	Contact	00322764	5714	selena.toma@uclouvain.be
Selma Kessler, Dentist	Contact	00322764	5714	selma.kessler@uclouvain.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques Universitaires Saint-Luc	Recruiting	Brussels		1200	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D055113	Chronic Periodontitis

Ancestor Terms

ID	Term
D010518	Periodontitis
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided