Adjunctive Local Sodium Hypochlorite Gel in Non Surgical Periodontal Debridement

NCT ID: NCT04399187

Last Updated: 2020-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-09-15

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.

Conditions

Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Sodium hypochlorite gel application

Intervention Type: 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.

scaling and root planing alone

scaling and root planing alone was performed

Group Type: PLACEBO_COMPARATOR

Sodium hypochlorite gel application

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Gel application

Eligibility Criteria

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

• Minimum Eligible Age: 32 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Messina

OTHER

Sponsor Role: lead

Responsible Party

Gaetano Isola, DDS, PhD

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaetano Isola

Role: STUDY_CHAIR

University of Messina

Locations

University of Messina

Messina, , Italy

Countries

Italy

Other Identifiers

16-18

Identifier Type: -

Identifier Source: org_study_id