Effect of Probiotic Lozenge on Gingivitis and Periodontitis

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Rėmėjai

CD Pharma India Pvt. Ltd.

Bendradarbiai

Government Dental College and Hospital, Vijayawada, Andra Pradesh, India

KLINIKINIS TYRIMAS: NCT02203812

BioSeek: NCT02203812

Raktažodžiai

Santrauka

The oral cavity is mostly influenced by general health. The oral microbiota which is as complex as the gastro-intestinal or vaginal microbiota are considered to be difficult therapeutic targets. The effects of probiotics in different fields of health care have resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been clinically proved effective in different fields of oral healthcare such as halitosis, oral candidiasis and tooth decay. They have also been inducted in the field of periodontal healthcare because of the current views on the etiology of plaque- related periodontal inflammation.

Datos

Paskutinį kartą patikrinta:	06/30/2016
Pirmasis pateikimas:	07/27/2014
Numatytas registravimas pateiktas:	07/28/2014
Pirmas paskelbtas:	07/29/2014
Paskutinis atnaujinimas pateiktas:	07/25/2016
Paskutinis atnaujinimas paskelbtas:	07/26/2016
Faktinė studijų pradžios data:	12/31/2014
Numatoma pirminio užbaigimo data:	01/31/2016
Numatoma studijų užbaigimo data:	04/30/2016

Būklė ar liga

Mild and Moderate Chronic Periodontitis

Intervencija / gydymas

Drug: Probiotic Arm

Drug: Placebo Arm

Fazė

Fazė 3

Rankų grupės

Ranka	Intervencija / gydymas
Experimental: Probiotic Arm L. brevis CD2 Lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). Each lozenge contains at least 1 billion colony forming units of Lactobacillus brevis CD2.	Drug: Probiotic Arm Each Inersan lozenge contains at least 1 billion colony forming unit of Lactobacillus brevis CD2
Placebo Comparator: Placebo Arm Placebo lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). The placebo lozenge contains all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2).	Drug: Placebo Arm Placebo lozenges contain all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2)

Tinkamumo kriterijai

Amžius, tinkami studijuoti	20 Years Į 20 Years
Tinkamos studijoms lytys	All
Priima sveikus savanorius	Taip
Kriterijai	Inclusion Criteria - Patients with chronic mild to moderate periodontitis. - Having Pocket depth > 4mm. - Mean loss of attachment, evaluated by measuring the distance from cement-enamel junction to the bottom of the probing pocket > 4mm Exclusion Criteria: - Patients on probiotic supplements - Patients who have allergy to lactose and fermented milk products - Smokers - Patients who are on antibiotic therapy or were on antibiotic therapy in the past 6 months - Patients with advanced periodontal and/or periapical conditions which necessitate immediate treatment - Patient suffering from any systemic illness - Patients who are deemed to be un-cooperative

Rezultatas

Pirminės rezultatų priemonės

1. Improvement in Clinical Periodontal Indices [8 weeks]

Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), Bleeding on Probing (BOP)

Antrinės rezultatų priemonės

1. Improvement in Biochemical Indices [8 weeks]

Changes in levels of Inflammatory markers, namely, Interleukin 1β, Matrix metalloproteinases-8 (MMP), Myeloperoxidase (MPO) and Calprotectin in Gingival Crevicular Fluid (GCF)

Effect of Probiotic Lozenge on Gingivitis and Periodontitis

Raktažodžiai

candidiasis

gingivitas

halitosis

uždegimas

periodontitas

dantų ėduonis

priešgrybeliniai