Comparison of Plaque Control Efficacy Of Chewing Gum Containing Ethylenediaminetetraaceticacid(EDTA),methylsulfonylmethane(MSM) and Xylitol with Chlorehexidine Mouthrinse
This study will be done with purpose of comparison of plaque control efficacy of chewing gum containing ethylenediaminetetraaceticacid, methyl sulfonyl methane and xylitol with chlorehexidine mouthrinse. For this purpose we choose 24 patients who referred to periodontics clinic of dental college of Hamedan University of Medical Sciences. These patients must have over 40% of O'leary plaque index and have no systemic diseases. This study is an interventional and cross-over designed. For each patient a SRP will be done and O'leary plaque index, gingival index and sulcus bleeding index will be recorded. Patients will be divided into two groups randomly. one group will recieve EDTA/MSM/Xylitol chewing gum and another group will receive chlorehexidine mouthrinse. After 14 days all 3 Indexes will be recorded again and a tooth polishing will be done for each patient. Groups' intervention will be changed and after another 14 days and all 3 Indexes will be recorded again and a tooth polishing will be done for each patient.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070234849N1
Registration date:2017-08-28, 1396/06/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-28, 1396/06/06
Registrant information
Name
Morteza Shakhs Niaee
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3252 6200
Email address
dr.niaee@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research and innovation of Hamedan University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Plaque Control Efficacy Of Chewing Gum Containing Ethylenediaminetetraaceticacid(EDTA),methylsulfonylmethane(MSM) and Xylitol with Chlorehexidine Mouthrinse
Public title
Considering the effect of a new chewing gum in preventing dental plaque formation
Purpose
Prevention
Inclusion/Exclusion criteria
patients must have over 40% of o'leary plaque index.
patients must have no systemic disease.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Ayatollah kashani boulevard, khaje rashid cross
City
Hamedan
Postal code
Approval date
2017-07-08, 1396/04/17
Ethics committee reference number
IR.UMSHA.REC.1396.306
Health conditions studied
1
Description of health condition studied
gingivitis and periodontitis
ICD-10 code
k05
ICD-10 code description
gingivitis and periodontal diseases
Primary outcomes
1
Description
O'leary plaque index
Timepoint
14 days
Method of measurement
Visionary scale using disclosing agents
2
Description
Gingival index
Timepoint
14 days
Method of measurement
Visionary scale of gingival inflammation
3
Description
sulcus bleeding index
Timepoint
14 days
Method of measurement
Visionary scale of sulcus bleeding
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
using EDTA/MSM/Xylitol chewing gum,twice a day,each time one piece of 2.7 gram gum, chewing for 10 minutes
Category
Prevention
2
Description
Control Group:
using 0.12% chlorehexidine mouthrinse, twice a day,each time 10 ml,rinsing for 30 seconds
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry College of Hamedan University of Medical Sciences
Full name of responsible person
morteza shakhs niaee
Street address
Hamedan University of Medical Sciences, Ayatollah Kashani boulevard, Khaje Rashid cross
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research and innovation of Hamedan University of Medical Sciences
Full name of responsible person
dr morad hedayati panah
Street address
Hamedan University of Medical Sciences, Ayatollah Kashani boulevard, Khaje Rashid cross
City
Hamedan
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 and innovation of Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Morteza Shakhs Niaee
Position
Dentistry student
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Ayatollah Kashani boulevard, Khaje Rashid cross
City
Hamedan
Postal code
Phone
+98 81 3525 0182
Fax
Email
dr.niaee@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Morad Hedayati Panah
Position
PHD
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Ayatollah Kashani boulevard, Khaje Rashid cross
City
Hamedan
Postal code
Phone
+98 81 3525 0182
Fax
Email
dr.hedayatipanah@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Morteza Shakhs Niaee
Position
Dentistry student
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Ayatollah Kashani boulevard, Khaje Rashid cross
City
Hamedan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)