Adjunctive Local Sodium Hypochlorite Gel in Non Surgical Periodontal Debridement

Study Overview
=================
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.

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

Conditions
-----------------
Periodontal Diseases

Intervention / Treatment
-----------------
* Drug: Sodium hypochlorite gel application


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 32 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: scaling and root planing, Sodium hypochlorite gel application<br>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<br>* 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.<br>* Other names: Gel application;|
| Placebo Comparator: scaling and root planing alone<br>scaling and root planing alone was performed | Drug: Sodium hypochlorite gel application<br>* 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.<br>* Other names: Gel application;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth changes | Changes over time in probing depth millimiters | 6-months |