(1) The goal of this study is to assess plaque removal and gingival abrasion by soft and medium toothbrushes in patients suffering from gingivitis. (2) In this study, which is a randomized, double-blinded clinical trial, (3) teeth of people suffering from gingivitis ,who will be included in the trial after signing written consent, will be divided into four quadrants. (4) Inclusion criteria: no history of systemic diseases; no history of periodontal treatment during the last year; sulcus depth of 3mm or less; number of present teeth over 20; diagnosis of gingivitis and plaque index of more than 50. Exclusion criteria: patient unwillingness or failure to cooperate; use of antibiotics or chemical plaque control methods; receiving periodontal treatment. (5) After scaling, all patients receive one soft and one medium toothbrushes and will brush each quadrant with one of them in the form of a cross for four weeks. (6) Finally, the amount of plaque, gingival index, and extent of gingival abrasion will be compared between the quadrants.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017100836648N1
Registration date:2017-11-16, 1396/08/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-16, 1396/08/25
Registrant information
Name
Zahra Sohrabi
Name of organization / entity
Kermanshah University of Medical Sciences - School of Dentistry
Country
Iran (Islamic Republic of)
Phone
+98 83337277030
Email address
z_sohrabi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Committee of Ethics in Research - Kermanshah University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
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 Removal and Gingival Abrasion between Soft and Medium Toothbrushes in Patients with Gingivitis
Public title
Comparison of Cleansing Ability and Gum Abrasion from Soft and Medium Toothbrushes in Patients with Inflamed Gum
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: No history of systemic diseases such as diabetes, etc. ; No history of periodontal treatment during the last year; Sulcus depth of 3 millimeters or less; Presence of no abrasion or recession in the gingiva; Number of present teeth over 20; Diagnosis of gingivitis and plaque index of 50 percent of more according to O'leary index.
Exclusion criteria: Patient incompliance; Leaving the trial by patients; Use of antibiotics during the tiral; Use of chemical plaque control methods during the trial; Patients receiving any other type of periodontal treatment during the trial.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee of Ethics in Research - Kermanshah University of Medical Sciences
Street address
Committee of Ethics in Research, Vice chancellor for research and technology, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Postal code
6715847167
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
KUMS.REC.1396.118
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05.1
ICD-10 code description
Gingivitis (chronic)
Primary outcomes
1
Description
Plaque index
Timepoint
Prior to intervention, 4 weeks after intervention
Method of measurement
Using O'leary index in percent
2
Description
Danser gingival abrasion index
Timepoint
Prior to intervention, 4 weeks after intervention
Method of measurement
Using Danser gingival abrasion index, in mean area per tooth
3
Description
Gingival index
Timepoint
Prior to intervention, 4 weeks after intervention
Method of measurement
Using gingival index, based on extent of bleeding on probing from 0 to 4
Secondary outcomes
empty
Intervention groups
1
Description
Use of medium toothbrush
Category
Prevention
2
Description
Use of soft toothbrush
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Kermanshah University of Medical Sciences, Kermanshah, Iran
Full name of responsible person
Zahra Sohrabi
Street address
School of Dentistry, Shariati St., Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research and technology, Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice Chancellor for Research and Technology, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
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 technology, Kermanshah 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
Kermanshah University of Medical Sciences - School of Dentistry
Full name of responsible person
Zahra Sohrabi
Position
Assistant professor
Other areas of specialty/work
Street address
School of Dentistry, Shariati St., Kermanshah
City
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Fax
Email
Z_sohrabi@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences - School of Dentistry
Full name of responsible person
Zahra Sohrabi
Position
Assistant professor
Other areas of specialty/work
Street address
School of Dentistry, Shariati St., Kermanshah
City
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Fax
Email
Z_sohrabi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Faryad Fatehi
Position
Student
Other areas of specialty/work
Street address
School of Dentistry, Shariati St., Kermanshah
City
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Fax
Email
fatahi.faryad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)