THE EFFECTIVENESS OF PROBIOTIC AND CHLORHEXIDINE MOUTH RINSES ON REDUCTION OF PLAQUE AND GINGIVITIS AMONG INTERN OF BPKIHS, DHARAN

A RANDOMIZED CONTROLLED CLINICAL STUDY.

Registration number: NPCTR2021000013
Register By : Anisha Sapkota
Registered Date : 2021/04/09
Email : anisssapkota@gmail.com
Titles & IDs
Refrence Number : REF/2021/04/000067
Public Title : THE EFFECTIVENESS OF PROBIOTIC AND CHLORHEXIDINE MOUTH RINSES ON REDUCTION OF PLAQUE AND GINGIVITIS AMONG INTERN OF BPKIHS, DHARAN
Scientific Title : THE EFFECTIVENESS OF PROBIOTIC AND CHLORHEXIDINE MOUTH RINSES ON REDUCTION OF PLAQUE AND GINGIVITIS AMONG INTERN OF BPKIHS, DHARAN : A RANDOMIZED CONTROLLED CLINICAL STUDY.
Trial Acronyms : A RANDOMIZED CONTROLLED CLINICAL STUDY.
Registration Type : Prospective
Secondary Id : anisssapkota@gmail.com
Recruitment Country : Nepal

For individuals in whom there is difficult to maintain an effective level of plaque control, mechanical method alone may not be sufficient to prevent onset/recurrence of dental and periodontal diseases so chemical methods of removing microbial biofilm have been recommended either as an adjunct or replacement for mechanical removal. Chlorhexidine being broad spectrum bis-biguanide is considered as gold standard till date having number of side effects. On other hand probiotic are natural beneficial bacteria which offer a natural and promising option to establish both oral and systemic health and can be used as an alternative /replacement approach in plaque control and gingival inflammation.

Principal Investigator (Trail coordinator for multi centric study)

Principal Investigator ( 1 )

Name
Anisha Sapkota
Email
anisssapkota@gmailcom
Contact No
9862696446
Designation
Junior Resident
Orgnizational Affilation
B.P Koirala Institute Of Health Sciences
Address
Ghopa Camp, Dharan
Country
Nepal

Contact person (scientific query)
Name
Anisha Sapkota
Email
anisssapkota@gmailcom
Contact No
9862696446
Designation
Junior Resident
Orgnizational Affilation
B.P Koirala Institute Of Health Sciences
Address
Ghopa Camp, Dharan
Country
Nepal

Contact person (Public Query)
Name
Anisha Sapkota
Email
anisssapkota@gmail.com
Contact No
9862696446
Designation
Junior Resident
Orgnizational Affilation
University
Address
BPKIHS
Country
Nepal

Contact person (Public Query)
Name
Anisha Sapkota
Email
anisssapkota@gmail.com
Contact No
9862696446
Designation
Junior Resident
Orgnizational Affilation
University
Address
BPKIHS
Country
Nepal

Sponsor
Type
Others (Please specify)
Name
Anisha Sapkota
Email
anisssapkota@gmail.com
Contact
9862696446
Address
Ghopa Camp ,Dharan

Recruitment Country
Country
Nepal

Site(s) of study
Site Address
BPKIHS
Contact Person Name
ANISHA SAPKOTA
Contact Person Email
anisssapkota@gmail.com
Contact Person Contact
9862696446

Ethics Committees Informations
Ethics Committee
Nepal Health Research Council
Ethics Committee Contact
014254220
Ethics Committee Address
Ram Shah path, Kathmandu
Ethics Committee Email
nhrc@nhrc.gov.np

Approvals
Status
Approved
Date
2021-02-05

Health condition(s)
Status
Particular health condition(s) or problem(s)

Study type
Thesis
Yes
Type of trial
Interventional
Study Type
Preventive, Preventive, Dentistry,

Study Design
Allocation
randomized controlled trial
Masking
blinded (masking used)
Control
active
Assignment
parallel
purpose
prevention
Trial Phase
N/A

Intervention and comparison
Intervention name
Probiotics and Chlorhexidine
Intervention details

A randomization master list will be prepared for 122 participants fulfilling the inclusion /exclusion criteria and willing to participate in the study. Based on computer generated random number by Microsoft Excel software each participant will be assigned to different groups (group A; probiotic mouth rinse and group B; chlorhexidine mouth rinse; CHX). Allocation concealment will be implemented by sequentially numbered, opaque, sealed envelope methods which conceal the sequence until interventions will assign. In this study only the investigator and analyzer will be blinded. And coding of each treatment will be decoded only after analyzing the result.

Plaque index (Silness J. and Loe H.) and Gingival index (Loe H. and Sillness J. 1963) ❖ Mouth mirror ❖ Dental explorer ❖ Periodontal probe ❖ Kidney tray ❖ Disposable mask ❖ Drape ❖ Disposable gloves ➢ Questionnaire to assess demographic data (Name, age, gender, class, school, oral hygiene behavior)

Participant will be given one test product according to assigned group and participants will be instructed to rinse twice daily for 14 days. All the participants must rinse with 10 ml of solution for 60 second, after 30 minutes of brushing followed by expectoration of residual mouth rinse. Participants will be clinically examined at baseline, at 15 day (14th day 0f intervention) and 21st (after discontinuation of intervention).

Written informed consent of each participant and consent from the hostel administration prior to examination will be obtained. Before the treatment, a careful medical and dental history will be taken, and study design will be explained to the qualifying participants. Interview of participants using pre-tested structured questionnaire will be done on sociodemographic status (name ,age ,gender, oral hygiene behavior) .Plaque index ( Silness J. and Loe H.) and Gingival index (Loe H. and Sillness J.) will be recorded in the predesigned proforma at baseline ,at 15th day (after intervention ) and 21st day (after discontinuation of intervention). Oral health education will be given using tooth model, flipcharts and poster. Oral health education will include topic like importance of teeth, type of dentition, brushing and flossing techniques, plaque and calculus -its effect on oral health.

The intervention group will be probiotic group with formulation prepared by mixing the Darolac sachet 1gm containing 1.25 billion freeze dried bacterial combination comprisedof Lactobacillus acidophilus, Lactobacillus ramnosus, Lactobacillus sporogens, Bifidobacterium longum, and Saccharomyces boulardii and10 ml ampules of distilled water. Similarly control group will be chlorhexidine group so, 10ml of Hexidine, chlorhexidine gluconate solution will be used. The investigator will supervise the probiotic mouth rinse by mixing the contents of sachet and 10ml distilled water. Emphasis will be given that the solution will be stirred thoroughly until all the contents were completely dissolved in the distilled water and preparation should be made freshly each time and rinse immediately once prepared and should not be stored. The individual will be instructed to rinse their mouth with 10ml of respective mouth rinse after tooth brushing twice daily by swishing it for 60 seconds and then expectorating it. They will also be advised not to eat and drink after using their mouth rinse. All participants will be reexamined for level of plaque accumulation and gingival inflammation at 15th day (after 14th day of use of intervention) and 21st day (after discontinuation of intervention)

Comparison name
chlorhexidine and Probiotic
Comparison details

The intervention group will be probiotic group with formulation prepared by mixing the Darolac sachet 1gm containing 1.25 billion freeze dried bacterial combination comprisedof Lactobacillus acidophilus, Lactobacillus ramnosus, Lactobacillus sporogens, Bifidobacterium longum, and Saccharomyces boulardii and10 ml ampules of distilled water. Similarly control group will be chlorhexidine group so, 10ml of Hexidine, chlorhexidine gluconate solution will be used. The investigator will supervise the probiotic mouth rinse by mixing the contents of sachet and 10ml distilled water. Emphasis will be given that the solution will be stirred thoroughly until all the contents were completely dissolved in the distilled water and preparation should be made freshly each time and rinse immediately once prepared and should not be stored. The individual will be instructed to rinse their mouth with 10ml of respective mouth rinse after tooth brushing twice daily by swishing it for 60 seconds and then expectorating it. They will also be advised not to eat and drink after using their mouth rinse. All participants will be reexamined for level of plaque accumulation and gingival inflammation at 15th day (after 14th day of use of intervention) and 21st day (after discontinuation of intervention)


Eligibility (Inclusion criteria)
Age Group
>18 years
Gender
Both
Detail
  • Individuals having 5 teeth in each quadrant.
  • Individuals with plaque index and gingival index score at least 1 or more than 1.
  • Individuals who consented to participate and consent from respective authority.
Exclusion Detail
  • Individuals with history of oral prophylaxis within past six months
  • Individuals using any other commercially available mouth rinses, probiotic products, or any other oral hygiene aids other than routine teeth brushing.
  • Individuals with malaligned teeth(crowding), orthodontics appliance, and removal partial denture.
  • Individuals suffering from any systemic illness [diabetes, rheumatic fever, liver or kidney disease, neurological deficiencies, immunological diseases or use of medication which may affect periodontal tissue, (phenytoin, cyclosporin, nifedipine, chronic use of non-steroidal anti- inflammatory drugs)
  • Individuals with known history of allergy to mouth rinse /drug.
  • Individuals who are tobacco consumer and smoker.
Sample Size
Considering 95% confidence interval and 80% power of study and mean score of plaque index from the study of Nadekerny et al. (15) Formula Where, δ : Equivalence limit of the difference in means will be 0.01 µT : Mean of the Test Treatment (probiotic) is
Enrollment Date
2021-04-15
Completion Date
2021-05-09
Enrollment Status
Pending