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

  • Italy
      • 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

28 years to 66 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
Drug: 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:
  • Gel application
Placebo Comparator: scaling and root planing alone
scaling and root planing alone was performed
Drug: 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:
  • Gel application

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

University of Messina

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.

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