Adjunctive Local Sodium Hypochlorite Gel in Non Surgical Periodontal Debridement

Periodontal Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04399187
• Other study ID #: 16-18
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: September 15, 2019

Study information

• Verified date: May 2020
• Source: University of Messina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 15, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 32 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

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.

Locations

Country	Name	City	State
Italy	University of Messina	Messina

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing depth changes	Changes over time in probing depth millimiters	6-months