Adjunctive Local Sodium Hypochlorite Gel in Non Surgical Periodontal Debridement

Not Applicable

Completed

• Conditions: Periodontal Diseases
• Interventions: Drug: Sodium hypochlorite gel application

• Registration Number: NCT04399187
• Lead Sponsor: University of Messina

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.

Study Timeline

• Study Start: 2018-04-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-15
• Status Verified: 2020-05
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-21
• Last Update Submitted: 2020-05-21
• Study First Posted: 2020-05-22
• Last Update Posted: 2020-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
scaling and root planing, Sodium hypochlorite gel application	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
scaling and root planing alone	Sodium hypochlorite gel application	scaling and root planing alone was performed

Primary Outcome Measures

Name	Time	Method
Probing depth changes	6-months	Changes over time in probing depth millimiters

Trial Locations

Locations (1)

University of Messina; 🇮🇹 Messina, Italy