| CTRI Number |
CTRI/2019/12/022372 [Registered on: 13/12/2019] Trial Registered Prospectively |
| Last Modified On: |
20/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Probiotic on Oral health- a Randomized controlled trial. |
|
Scientific Title of Study
|
CLINICAL AND MICROBIOLOGICAL EFFECT OF PROBIOTIC ON ORAL HEALTH- A RANDOMIZED CONTROLLED TRIAL. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BADE JYOSNA |
| Designation |
Master of dental surgery |
| Affiliation |
Dr.NTR university of health sciences, Vijayawada |
| Address |
Narayana Dental College and Hospital, Room number-9, Public health dentistry department, Chinthareddy palem,
Nellore, Andhra Pradesh.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
|
| Fax |
|
| Email |
jyosnabade.jb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Chandrasekhara Reddy |
| Designation |
Professor and HOD |
| Affiliation |
NTR university of health sciences |
| Address |
Narayana dental college and hospital, room no 9, public health dentistry, chinthareddy palem, Nellore, Andhrapradesh.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
|
| Fax |
|
| Email |
Dr.chandu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BADE JYOSNA |
| Designation |
master of dental surgery |
| Affiliation |
Dr NTR university of health science |
| Address |
Narayana dental college and hospital, room no-9, public health dentistry department, chinthareddy palem,
Nellore, Andhrapradesh.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
|
| Fax |
|
| Email |
jyosnabade.jb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana dental college and hospital, Chinthareddy palem, Nellore, 524003. |
|
|
Primary Sponsor
|
| Name |
BADE JYOSNA |
| Address |
Narayana dental college and hospital, chinthareddy palem, nellore, andhrapradesh. |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bade Jyosna |
Narayana Dental College and Hospital |
room number 9, public health dentistry department.
Nellore
ANDHRA PRADESH |
8885432939
jyosnabade.jb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| narayana dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy individuals with moderate gingivitis. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
enkor instamelt |
1gm sachet, contains streptococcus salivarius and lactobacillus specie. |
| Comparator Agent |
non sugar milk powder |
no relavent details. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
1. having orthodontic appliances, RPD, FPD.
2. Patients with a history of periodontal
surgery during the previous three months
from the day of examination.
3. Subjects under any other form of
probiotic products.
4. Pregnant or lactating females will be
excluded.
5. Subjects under anti-inflammatory
medication or antibiotic past four weeks
to the study.
6. Subjects with systemic diseases.
7. Subjects with malaligned teeth.
8. Prescribed medication with a known
effect on gingival growth.
9. Subjects with carious lesions, fluorosis.
10. Using commercially available mouth
rinse and having smoking habit.
11. Subjects with non-plaque induced
gingivitis. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
gingival status- Loe and Sillness gingival index, plaque status- Turesky-Gilmore-Glickman plaque index,
CFU of streptococcus - CRT bacteria test.
|
1st day (baseline), 7th day, 21st day and 49th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| plaque status- turesky-gilmore-glickman modification of quigley hein plaque index. |
baseline, day 7, day 21 and after 4weeks. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/12/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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. |