Aim:the present study sought to compare the effects of chewing xylitol-containing gums and conventional gums on S. mutans in the saliva of subjects with moderate and poor oral hygiene.
Design:This study adopt a crossover design. Two type of chewing gums (one containing 70% xylitol and approve by the Iranian Dental Association and another containing sucrose) were purchase. The participants are 32 individuals aged18-35 years old whose oral hygiene are categorize as moderate or poor based on caries-risk assessment table.
Setting and conduct: Either All subjects were instruct to take three gums a day after main meals (breakfast, lunch, and dinner ) and chew each gum for 15 minute.
The two groups with moderate and poor oral hygiene (n = 16) were each divide into two groups of eight to receive either PK® gums or Xylitol gums during the first 10-day period. After a 10-day washout period, each group receive the other type of gums for another 10 days. Saliva samples were collected and tested before and after each stage. Salivary levels of S. mutans were measure at baseline, after the first and second phases of chewing gums, and after the washout period. The measurements are performed on blood agar and mitis salivarius bacitracin agar When the presence of S. mutans was confirmed, the number of S. mutans colonies forme on the blood agar medium was count. Pair wise comparisons are then use to analyze the collecte data.
Participant including major: Individuals were not included if they have any systemic diseases, history of head and neck radiotherapy, or sensitivity to xylitol. Persons receiving any type of antibiotics are not included
Intervention: using sugar free xylitol chewing gum and sugared gum in poor and moderate oral hygiene group.
Main out come measure: Salivary levels of S. mutans were measure at baseline and after the first and second phases of chewing gums, and after the washout period. the number of s. mutans compared between poor and moderate oral hygiene group
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015093024274N1
Registration date:2015-12-21, 1394/09/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-21, 1394/09/30
Registrant information
Name
Elahe Afshari Esfidvajani
Name of organization / entity
Shahed univercity, Dental school
Country
Iran (Islamic Republic of)
Phone
+98 913 309 1663
Email address
mostajeran@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of sugar free chewing gum to reduce cariogenic microorganism
Public title
Effect of sugar free chewing gum on main caries induce microorganism
Purpose
Prevention
Inclusion/Exclusion criteria
Exclution criteria: Any systemic diseases؛ history of head and neck radiotherapy؛ or sensitivity to xylitol؛ Persons receiving any type of antibiotics were not included either
Age
From 18 years old to 35 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed university,dental school
Street address
Number 39, Italy St, Vesal St, Enghelab St
City
Tehran
Postal code
1417755351
Approval date
2014-07-06, 1393/04/15
Ethics committee reference number
41/205159
Health conditions studied
1
Description of health condition studied
Assessment the effect of chewing gum on salivary S. mutans count
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Streptococcus mutans count
Timepoint
Immediately befor start first 10 days intervention and immediately after finish first ten days period and immediatly after finish ten days wash out period and immediatly after finish second ten days intervention
Method of measurement
Microbiologic test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group a: Xylitol chewing gums (Orion Food Vina Co. Ltd, Vietnam) containing 70% xylitol, isomalt, Arabic gum, and calcium lactate were purchased from a gum wholesaler in Tehran . The gums were 1.5 g each and were approved by the Iranian Dental Association. All subjects were instructed to take three gums a day after main meals (breakfast, lunch, and dinner) and chew each gum for 15 minutes. for ten days period
Category
Prevention
2
Description
Intervention group b: PK® gums (1.6 g, Wrigley, India) containing sucrose, glucose, gum, mint extract, pigments, titanium dioxide, were also purchased. The chewing gums were packed in similar 30-gum packages and distributed among the participants. All subjects were instructed to take three gums a day after main meals (breakfast, lunch, and dinner) and chew each gum for 15 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahed university, faculty of dentistry
Full name of responsible person
Karami
Street address
Number 39, Italy St, Vesal St, Enghelab St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of dental school of Shahed university
Full name of responsible person
MIS Gharaje
Street address
Number 39, Italy St, Vesal St, Enghelab St
City
Tehran
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 of dental school of Shahed university
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
Shahed university, Faculty of dentistry
Full name of responsible person
Roza Haghgoo
Position
Pedodontist/Professor, Dept of Pediatric Dentistry, Dental School, Shahed University
Other areas of specialty/work
Street address
Number 39, Italy St, Vesal St, Enghelab St
City
Tehran
Postal code
1417755351
Phone
+98 21 8836 0461
Fax
+98 21 8836 0461
Email
haghgoodent@yahoo.com
Web page address
Shahed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University, Dental school
Full name of responsible person
Roza Haghgoo
Position
Pedodontist
Other areas of specialty/work
Street address
Number 39, Italy St, Vesal St, Enghelab St
City
Tehran
Postal code
1417755351
Phone
+98 21 8836 0461
Fax
+98 21 8836 0461
Email
haghgoodent@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University, Dental school
Full name of responsible person
Elahe Afshari
Position
Resident, Dept of Pediatric Dentistry
Other areas of specialty/work
Street address
Number 39, Italy St, Vesal St, Enghelab St
City
Tehran
Postal code
Phone
+98 21 8836 0461
Fax
+98 21 8836 0461
Email
Elaheafshar59@gmail
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)