- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04399187
Adjunctive Local Sodium Hypochlorite Gel in Non Surgical Periodontal Debridement
May 21, 2020 updated by: Gaetano Isola, DDS, PhD, University of Messina
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Messina, Italy, 98100
- University of Messina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: scaling and root planing, Sodium hypochlorite gel application
Periodontal pockets > 5 mm in patients of test group were treated by scaling and root planing and Sodium hypochlorite gel application
|
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.
Other Names:
|
Placebo Comparator: scaling and root planing alone
scaling and root planing alone was performed
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probing depth changes
Time Frame: 6-months
|
Changes over time in probing depth millimiters
|
6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Gaetano Isola, University of Messina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2018
Primary Completion (Actual)
September 1, 2019
Study Completion (Actual)
September 15, 2019
Study Registration Dates
First Submitted
May 13, 2020
First Submitted That Met QC Criteria
May 21, 2020
First Posted (Actual)
May 22, 2020
Study Record Updates
Last Update Posted (Actual)
May 22, 2020
Last Update Submitted That Met QC Criteria
May 21, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Sharing study results
IPD Sharing Time Frame
6-months
IPD Sharing Access Criteria
University website and pubmed
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Periodontal Diseases
-
G. d'Annunzio UniversityNot yet recruitingPeriodontal Diseases | Intrabony Periodontal Defect | Periodontal Attachment Loss | Pocket, Periodontal
-
University of BeykentCompletedPeriodontal Diseases | Periodontal Attachment Loss | Periodontal Inflammation | Periodontal Disease, AVDC Stage 3 | Periodontal Disease, AVDC Stage 4Turkey
-
British University In EgyptRecruitingPeriodontal Diseases | Periodontal Pocket | Periodontal Attachment Loss | Periodontal InflammationEgypt
-
Technische Universität DresdenCompletedPeriodontal Disease | Periodontal Attachment LossGermany
-
Universidad de MurciaCompletedPeriodontitis | Periodontal Diseases | Periodontal Pocket | Periodontal Attachment LossSpain
-
Brock UniversityDr. Peter C. Fritz, Periodontal Wellness & Implant SurgeryCompletedPeriodontal Pocket | Periodontal Attachment LossCanada
-
Texas A&M UniversityInstitut Straumann AGRecruitingPeriodontitis | Attachment Loss, PeriodontalUnited States
-
Queen Mary University of LondonGeistlich Pharma AGNot yet recruitingPeriodontal Diseases | Wound Heal | Periodontal Pocket | Periodontal Attachment Loss | Periodontal InflammationUnited Kingdom
-
University of FlorenceRecruitingPeriodontitis | Periodontal Pocket | Periodontal Attachment LossItaly
-
Brock UniversityDr. Peter C. Fritz, Periodontal Wellness & Implant SurgeryCompleted
Clinical Trials on Sodium hypochlorite gel application
-
University of RochesterNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsCompleted
-
Cairo UniversityCompleted
-
Yuzuncu Yıl UniversityCompleted
-
Damascus UniversityCompletedDental Caries | Infection, Bacterial | Tooth, DeciduousSyrian Arab Republic
-
University of Campinas, BrazilCompleted
-
Damascus UniversityActive, not recruitingDental CariesSyrian Arab Republic
-
Cukurova UniversityCompleted
-
TopMD Skin Care, Inc.WithdrawnArterial Bypass Graft SurgeryUnited States
-
Federal University of PelotasUnknownNon-carious Cervical LesionsBrazil
-
Cairo UniversityNot yet recruiting