Protocol summary

Summary
Chewing gum containing xylitol or CCP-ACP is known to be a useful adjunct to common oral hygiene because of stimulation of salivary flow rate. It is effective in raising plaque ph. The chewing of sugar-free gums after meals and snacks can promote remineralization of enamel and reduce S. mutant rate independent of chewing frequency and duration.. Probiotics are viable microorganisms which improve human health by inhibiting or reducing the number of pathogenic microorganisms. To have a favorable effect on oral health, a probiotic must have the capacity to adhere to tooth surfaces and must be integrated in the bacterial biofilm; it should also be able to compete with cariogenic bacteria and prevent their proliferation. The aim of this study was to evaluate the effect of xylitol and CCP-ACP chewing gums and probiotic yogurt on oral periodontal indices. The participants are consist of 120 healthy dental students that have good oral health. The exclusion criteria are: systemic diseases that affect dental and periodontal conditions; orthodontic appliance; active dental caries; chronic mucositis; chronic antibiotic usage; antibacterial mouth rinse consumption; drugs consumption which affect saliva flow rate and radio therapy history. They were assigned by random into one of four parallel study groups: 1, CCP-ACP gum group; 2, xylitol gum group; 3, probiotic yogurt group; and 4, chlorehexidin group. Chewing Gum is consumed three times a day after a meal. Probiotic yogurt is consumed once a day. Chlorhexidine mouthwash was used once a day after brushing in night. The intervention period is 1 month. In base line and after 15 and 30 days periodontal indices recorded. The difference between the baseline value and the secondary and tertiary value of indices will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017020432380N1
Registration date: 2017-06-13, 1396/03/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-13, 1396/03/23
Registrant information
Name
Maryam Mehrabkhani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9501
Email address
mehrabkhanim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of CCP-ACP & Xylitol chewing gum & probiotic yogurt on periodontal indices
Public title
Comparison of the effect of CCP-ACP & Xylitol chewing gum & probiotic yogurt on periodontal indices
Purpose
Prevention
Inclusion/Exclusion criteria
Dental students who have 22 teeth and good oral hygiene were attended to this study. Exclusion criteria: systemic diseases that affect dental and periodontal conditions; orthodontic appliance; active dental caries; chronic mucositis; chronic antibiotic usage; antibacterial mouth rinse consumption; drugs consumption which affect saliva flow rate and radio therapy history.
Age
From 19 years old to 27 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medic al Sciences Ethics Committee
Street address
Mashhad University of Medic al Sciences, Vakil Abad blvd.
City
Mashhad
Postal code
Approval date
2017-02-08, 1395/11/20
Ethics committee reference number
IR.MUMS.SD.REC.1394.200

Health conditions studied

1

Description of health condition studied
,gingival bleeding ,dental plaque , dental calculus, dental debris
ICD-10 code
Z01.2­k03.
ICD-10 code description
DENTAL EXAMINATIONDeposites on tooth

Primary outcomes

1

Description
Dental debries
Timepoint
base line ­15 day­30 day
Method of measurement
debries index

2

Description
Dental plaque
Timepoint
base line ­15 day­30 day
Method of measurement
plaque index

3

Description
bleeding
Timepoint
base line ­15 day­30 day
Method of measurement
gingival index

4

Description
Dental calculus
Timepoint
base line ­15 day­30 day
Method of measurement
calculus index

Secondary outcomes

empty

Intervention groups

1

Description
Group 1: participants in this group chew one pellet of gum containing xylitol to 3 times a day after meals for 20 minutes and for 30 day
Category
Treatment - Drugs

2

Description
Group 2: participants in this group chew a piece of gum containing ccp-acp 3 times a day after meals for 20 minutes and for 30 day
Category
Treatment - Drugs

3

Description
Group 3: Participants in this group ate 200 grams of probiotic yogurt once a day for 30 days
Category
Treatment - Drugs

4

Description
Group 4: Participants in this group using 5 ml Chlorhexidine 0.12 % every night for 1 min for 15 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad Dental Faculty
Full name of responsible person
Maryam Mehrabkhani
Street address
Mashhad Dental Faculty, Vakil Abad blvd.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
School of Pharmacy, Nanotechnology Research Center, Mashhad University of Medical Sciences, Mashhad-Iran
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad Dental Faculty
Full name of responsible person
Maryam Mehrabkhani
Position
Associate professor of Pediatric Dentistry
Other areas of specialty/work
Street address
Mashhad Dental Faculty, Vakil Abad blvd.
City
Mashhad
Postal code
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
mehrabkhanim@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad Dental Faculty
Full name of responsible person
Maryam Mehrabkhani
Position
Associate Professor of Pediatric Dentistry
Other areas of specialty/work
Street address
Mashhad Dental Faculty, Vakil Abad blvd.
City
Mashhad
Postal code
Phone
+98 51 3882 9501
Fax
Email
mehrabkhanim@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad Dental Faculty
Full name of responsible person
Maryam Mehrabkhani
Position
Associate professor
Other areas of specialty/work
Street address
Mashhad Dental Faculty, Vakil Abad blvd.
City
Mashhad
Postal code
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
mehrabkhanim@mums.as.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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