Effect of Probiotic on Oral health- a Randomized controlled trial.

Phase 4

Suspended

Conditions: Systemically healthy individuals with moderate gingivitis.

Registration Number: CTRI/2019/12/022372

Lead Sponsor: BADE JYOSNA

Brief Summary: The oral hygiene of the oral cavity can be maintained through different methods of plaque control. Regular mechanical removal of dental plaque through oral hygiene practices, together with professional intervention to eliminate already established plaque are the critical elements in gingival management. Probiotics administered orally may benefit oral health by preventing the growth of harmful micro biota in the oral cavity for the prevention of oral diseases. A randomized, parallel arm, triple blinded clinical trial will be conducted to assess the effectiveness of probiotic (Streptococcus and Lactobacillus strains) on dental plaque, gingival health, and salivary Streptococcus mutans count. Examination of the subjects will be done in the Department of Public Health Dentistry, Narayana Dental College & Hospital, Nellore. Study will be over a period of seven weeks with a total of four visits- baseline, 7th day, 21st day(after 21days of intervention), and four weeks after discontinuation of intervention for each subject. Subjects who will satisfy inclusion criteria will be invited to participate in study and these subjects will be allocated into 2 groups. The randomization will be done using a lottery method. clinical examination of subject will be performed using gingival index (Loe H and Silness J, 1963), plaque index (Turesky, Gilmore, Glickman modification of Quigley Hein plaque index, 1970). Data will be collected using clinical examination for gingivitis assessment using gingival index, plaque assessment using Turesky, Gilmore, Glickman modification of Quigley Hein plaque index and colony forming units of streptococcus are calculated using CRT bacteria test. The collected data will be analyzed using SPSS 22 version.

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: All

Target Recruitment: 30

Inclusion Criteria

Systemically healthy individuals with moderate gingivitis Subjects having at least 20 natural teeth.
Who will be ready to follow and take the regimen as instructed during study period.

Exclusion Criteria

having orthodontic appliances, RPD, FPD.
Patients with a history of periodontal surgery during the previous three months from the day of examination.
Subjects under any other form of probiotic products.
Pregnant or lactating females will be excluded.
Subjects under anti-inflammatory medication or antibiotic past four weeks to the study.
Subjects with systemic diseases.
Subjects with malaligned teeth.
Prescribed medication with a known effect on gingival growth.
Subjects with carious lesions, fluorosis.
Using commercially available mouth rinse and having smoking habit.
Subjects with non-plaque induced gingivitis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
gingival status- Loe and Sillness gingival index, plaque status- Turesky-Gilmore-Glickman plaque index,	1st day (baseline), 7th day, 21st day and 49th day.
CFU of streptococcus - CRT bacteria test.	1st day (baseline), 7th day, 21st day and 49th day.

Secondary Outcome Measures

Name	Time	Method
plaque status- turesky-gilmore-glickman modification of quigley hein plaque index.	baseline, day 7, day 21 and after 4weeks.

Trial Locations

Locations (1): Narayana Dental College and Hospital
🇮🇳
Nellore, ANDHRA PRADESH, India
Narayana Dental College and Hospital
🇮🇳Nellore, ANDHRA PRADESH, India
Bade Jyosna
Principal investigator
8885432939
jyosnabade.jb@gmail.com