Determination and comparison of sodium fluoride mouthwash and chlorhexidine mouthwash on gingivitis
Design
Clinical trials with control group, with parallel groups, double-blind, randomized
Settings and conduct
100 patients with gingivitis referred to the periodontics department of Zahedan School of Dentistry, were divided randomly into two groups. After the clinical examination, plaque index and Gingival inflammation were recorded on specific charts. Each patient was given one of the mouthwashes according to his/her group. After two weeks, the plaque index and gingival inflammation was measured again and analyzed statistically.
Participants/Inclusion and exclusion criteria
Patients 15 to 30 years old with gingivitis; at least 20 permanent teeth without extensive restoration; non-use of partial dentures and orthodontic appliance; non-smoking; non-use of antibiotics and mouthwash in the last three months.
Intervention groups
Group 1: Use sodium fluoride mouthwash for two weeks
Group 2: Use of chlorhexidine mouthwash for two weeks
Main outcome variables
Dental plaque; Gingival bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180718040522N1
Registration date:2018-07-28, 1397/05/06
Registration timing:retrospective
Last update:2018-07-28, 1397/05/06
Update count:0
Registration date
2018-07-28, 1397/05/06
Registrant information
Name
Masoud Bamedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3342 9519
Email address
z@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-28, 1397/03/07
Expected recruitment end date
2018-06-28, 1397/04/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of fluoride mouthwash with chlorhexidine on gingivitis in 15 to 30 year olds inviduals.
Public title
Comparison of the effect of two mouthwashes on gingivitis in 15 to 30 years old inviduals.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least 20 teeth without massive restoration
Exclusion criteria:
Use of partial denture
Use of orthodontic appliances
Systemic diseases
Periodontitis disease
Tobacco use
Taking any antibiotic over the past three months
Taking any mouthwash over the past three months
Age
From 15 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Using random block method, subjects will be categorized in one of the two examined groups. Randomly, numbers from one form of 1 to 10 are selected and written in sequence. We assign the numbers below 5 as AB and assign the upper 5 numbers to BA and based on the given number we categorize persons in either AB or BA group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The same mouthwashes are provided by the other person to the patients and so the patient, the therapist, and the researcher are unaware of the type of mouthwash used, and also the person who is analyzing the data is unaware of the kind of used mouthwash.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
ZaUMS Main campus, Jenat Blvd., Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-05-27, 1397/03/06
Ethics committee reference number
IR. ZAUMS. REC.1397.101
Health conditions studied
1
Description of health condition studied
Gingival inflammation
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
Dental plaque
Timepoint
Two weeks after use of mouthwash
Method of measurement
Plaque index (silness and loe plaque index)
2
Description
Gingival bleeding
Timepoint
Two weeks after use of mouthwash
Method of measurement
Evaluation of BOP by williams periodontal prob according to silness and loe index
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Use of 0.2% Chlorhexidine mouthwash for two weeks
Category
Treatment - Drugs
2
Description
Intervention group: Use of 0.05% sodium fluoride mouthwash for two weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan University of medical sciences
Full name of responsible person
Abdolghafour Pakseresht
Street address
College of dentistry , Eastern Azadegan St. , Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1814
Email
final047@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Nourmohammad Bakhshani
Street address
ZaUMS Main campus, Jenat Blvd., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3342 5765
Email
nmbakhsha@Zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Abdolghafour Pakseresht
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
College of dentistry, Eastern Azadegan st.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3329 5715
Email
final047@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Masoud Bamedi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
College of dentistry , Eastern Azadegan St. , Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3342 9519
Fax
Email
z@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Masoud Bamedi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
College of dentistry , Eastern Azadegan St. , Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3342 9519
Fax
Email
z@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available