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Slow-release Locally Administered 0.02% Hypochlorite Formulation

Primary Purpose

Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PerioTabs® brushing solution
Chlorhexidine 0.12 %
Sponsored by
Tuscan Dental Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Periodontal Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: older than 18 y.o, systemically healthy, with a clinical diagnosis of periodontitis Exclusion Criteria: alcohol or drug abuse, regular drug use of bisphosphonates, non-steroidal or steroidal anti-inflammatory, daily antacid therapy, selective serotonin reuptake inhibitors and other therapy that might affect periodontal health, antibiotics during the previous 6 months, smoking more than ten cigarettes per day; pregnancy; lactation; previous periodontitis treatment within the last 6 months, radiotherapy to the head or neck, current chemotherapy.

Sites / Locations

  • Fortis Centro Odontoiatrico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PerioTabs® brushing solution

Chlorhexidine 0.2% mouth rinse

Arm Description

At baseline, patients were given instructions for the home use of PerioTabs® for daily gum and toothbrushing for 10 consecutive days, according to the product's directions for use. The procedure consisted of brushing the teeth and gums for 2 minutes in the evening during a 10-day period. After one week, one-stage full-mouth disinfection was performed with the use of ultrasonic devices on each quadrant. In addition, two cycles of 90 seconds ozone-therapy were carried out.

At baseline, patients were given instructions for the home use of toothbrush with chlorhexidine 0.12 % toothpaste for 15 days toothbrushing twice daily (morning and evening). Also, a chlorhexidine 0.2% mouth rinse had to be used every evening for the course of the 15 days. After two weeks, the one-stage full-mouth disinfection was performed in the same way as in Group 1.

Outcomes

Primary Outcome Measures

change in full mouth bleeding score (ΔFMBS)

Secondary Outcome Measures

Full Information

First Posted
April 16, 2023
Last Updated
April 26, 2023
Sponsor
Tuscan Dental Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05846139
Brief Title
Slow-release Locally Administered 0.02% Hypochlorite Formulation
Official Title
The Effectiveness of an Incremental Approach to Nonsurgical Periodontal Therapy With the Use of Adjunctive Slow-release Locally Administered 0.02% Hypochlorite Formulation: A Single-blind Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 17, 2022 (Actual)
Primary Completion Date
November 21, 2022 (Actual)
Study Completion Date
November 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tuscan Dental Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim: The presence of bacterial plaque is associated with the development of periodontal inflammation. The aim of this single-blind randomized clinical study was to prospectively evaluate the efficacy of two different agents in a staged approach for nonsurgical periodontal treatment in terms of clinical and patients related outcomes in a cohort of patients with periodontitis: NitrAdine® based disinfectant formula (PerioTabs®) vs Chlorhexidine 0.12 toothpaste and mouthwash 0.20. Material and methods: Patients with a diagnosis of periodontal disease (stage I-III) scheduled for non surgical periodontal treatment were randomly allocated to the preparatory home use of a chlorhexidine mouthwash or a NitrAdine® based brushing solution called PerioTabs® for 10-15 days. Active decontamination with ultrasonic scalers was performed after the completion of the preparation period. Clinical and patient-related outcomes were recorded at baseline, at the moment of professional intervention, and after 30 and 90 days from baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PerioTabs® brushing solution
Arm Type
Experimental
Arm Description
At baseline, patients were given instructions for the home use of PerioTabs® for daily gum and toothbrushing for 10 consecutive days, according to the product's directions for use. The procedure consisted of brushing the teeth and gums for 2 minutes in the evening during a 10-day period. After one week, one-stage full-mouth disinfection was performed with the use of ultrasonic devices on each quadrant. In addition, two cycles of 90 seconds ozone-therapy were carried out.
Arm Title
Chlorhexidine 0.2% mouth rinse
Arm Type
Active Comparator
Arm Description
At baseline, patients were given instructions for the home use of toothbrush with chlorhexidine 0.12 % toothpaste for 15 days toothbrushing twice daily (morning and evening). Also, a chlorhexidine 0.2% mouth rinse had to be used every evening for the course of the 15 days. After two weeks, the one-stage full-mouth disinfection was performed in the same way as in Group 1.
Intervention Type
Combination Product
Intervention Name(s)
PerioTabs® brushing solution
Intervention Description
PerioTabs® contains a non-antibiotic biofilm removal complex called NitrAdine®.Its anti-biofilm action is based on the combination of surfactant-induced protein denaturation and slow release of a non-toxic concentration of hypochlorite (0.02%).
Intervention Type
Combination Product
Intervention Name(s)
Chlorhexidine 0.12 %
Intervention Description
chlorhexidine 0.12 % toothpaste and chlorhexidine 0.2% mouth rinse
Primary Outcome Measure Information:
Title
change in full mouth bleeding score (ΔFMBS)
Time Frame
Between baseline and the active debridement which occurred 15 days later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: older than 18 y.o, systemically healthy, with a clinical diagnosis of periodontitis Exclusion Criteria: alcohol or drug abuse, regular drug use of bisphosphonates, non-steroidal or steroidal anti-inflammatory, daily antacid therapy, selective serotonin reuptake inhibitors and other therapy that might affect periodontal health, antibiotics during the previous 6 months, smoking more than ten cigarettes per day; pregnancy; lactation; previous periodontitis treatment within the last 6 months, radiotherapy to the head or neck, current chemotherapy.
Facility Information:
Facility Name
Fortis Centro Odontoiatrico
City
Forte Dei Marmi
State/Province
Lucca
ZIP/Postal Code
55042
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data are available upon reasonable request from colleagues

Learn more about this trial

Slow-release Locally Administered 0.02% Hypochlorite Formulation

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