Back to resultsAdjunctive Local Sodium Hypochlorite Gel in Non Surgical Periodontal Debridement
Primary Purpose
Periodontal Diseases
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Sodium hypochlorite gel application
Sponsored by
About this trial
This is an interventional supportive care trial for Periodontal Diseases
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with periodontitis;
- Age > 18 years old;
- Patients with at least 10 teeth for arch;
- Presence at least of two teeth with PD > 5 mm for quadrant;
- Single-rooted and multi-rooted teeth;
Exclusion Criteria:
- Patients with systemic diseases;
- Pregnant or lactating;
- Tobacco smokers (> 10 cigarettes/day);
- Previous periodontal treatment in the last 2 years;
- Prolonged antibiotic treatment or anti-inflammatory treatment within 6 months prior to periodontal therapy;
- Furcation involvement;
- Acute periodontal or endodontic abscess;
- Third molars
Sites / Locations
- University of Messina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
scaling and root planing, Sodium hypochlorite gel application
scaling and root planing alone
Arm Description
Periodontal pockets > 5 mm in patients of test group were treated by scaling and root planing and Sodium hypochlorite gel application
scaling and root planing alone was performed
Outcomes
Primary Outcome Measures
Probing depth changes
Changes over time in probing depth millimiters
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04399187
Brief Title
Adjunctive Local Sodium Hypochlorite Gel in Non Surgical Periodontal Debridement
Official Title
Clinical Effects of Adjunctive Local Sodium Hypochlorite Gel in Minimally Invasive Non Surgical Debridement (MINSD) of Periodontal Pockets. A 6-month Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Messina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study was to assess the efficacy of minimally invasive nonsurgical debridement (MINSD) of periodontal pockets with or without local amino acid buffered sodium hypochlorite (NaOCl) gel application after 6 months follow-up.
Detailed Description
Forty periodontal compromised patients were randomly allocated in two groups. Periodontal pockets > 5 mm in patients of test group were treated by MINSD and NaOCl gel application, meanwhile in patients of control group MINSD alone was performed. Full-mouth plaque score (FMPS) , Full-mouth bleeding score (FMBS), probing depth (PD), clinical attachment level (CAL) and gingival recession (GR) were assessed at baseline and after 6 months follow-up.
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
scaling and root planing, Sodium hypochlorite gel application
Arm Type
Experimental
Arm Description
Periodontal pockets > 5 mm in patients of test group were treated by scaling and root planing and Sodium hypochlorite gel application
Arm Title
scaling and root planing alone
Arm Type
Placebo Comparator
Arm Description
scaling and root planing alone was performed
Intervention Type
Drug
Intervention Name(s)
Sodium hypochlorite gel application
Other Intervention Name(s)
Gel application
Intervention Description
Patients treated by scaling and root planing and Sodium hypochlorite gel application, meanwhile in patients of control group scaling and root planing alone was performed.
Primary Outcome Measure Information:
Title
Probing depth changes
Description
Changes over time in probing depth millimiters
Time Frame
6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
32 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with periodontitis;
Age > 18 years old;
Patients with at least 10 teeth for arch;
Presence at least of two teeth with PD > 5 mm for quadrant;
Single-rooted and multi-rooted teeth;
Exclusion Criteria:
Patients with systemic diseases;
Pregnant or lactating;
Tobacco smokers (> 10 cigarettes/day);
Previous periodontal treatment in the last 2 years;
Prolonged antibiotic treatment or anti-inflammatory treatment within 6 months prior to periodontal therapy;
Furcation involvement;
Acute periodontal or endodontic abscess;
Third molars
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola
Organizational Affiliation
University of Messina
Official's Role
Study Chair
Facility Information:
Facility Name
University of Messina
City
Messina
ZIP/Postal Code
98100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Sharing study results
IPD Sharing Time Frame
6-months
IPD Sharing Access Criteria
University website and pubmed
Learn more about this trial
Adjunctive Local Sodium Hypochlorite Gel in Non Surgical Periodontal Debridement
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