Adjunctive Local Sodium Hypochlorite Gel in Non Surgical Periodontal Debridement

NCT04399187 | Completed DMC

• 1 other identifier: 16-18
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• Probing depth changes

  Changes over time in probing depth millimiters

  6-months

Study Arms (2)

scaling and root planing, Sodium hypochlorite gel application

EXPERIMENTAL

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

scaling and root planing alone

PLACEBO COMPARATOR

scaling and root planing alone was performed

Drug: Sodium hypochlorite gel application

Interventions

Sodium hypochlorite gel application DRUG

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.

Also known as: Gel application

scaling and root planing alone; scaling and root planing, Sodium hypochlorite gel application

Eligibility Criteria

• Age: 32 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Messina: lead

Study Sites (1)

University of Messina

Messina, 98100, Italy

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Gaetano Isola

  University of Messina

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 22, 2020
• Study Start: April 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 15, 2019
• Last Updated: May 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6-months
• Access Criteria: University website and pubmed

Locations

IT (1)