Comparative evaluation of the effectiveness of a Persica-containing toothpaste over a Persica-free toothpaste in patients with plaque-induced gingivitis
Comparison of effectiveness of a Persica-containing toothpaste and a Persica-free toothpaste in plaque induced gingivitis
Design
A clinical trial with the control group, parallel-group, triple-blind, Randomized on 140 patients trial
Settings and conduct
This study takes part in the field of periodontology in the dentistry department of the dental University of medical sciences. Patients with plaque-induced gingivitis will be treated by phase 1 treatment and then will use toothpaste and will be followed up within different intervals. In this study the patient, examiner, analytical counselor, person handling the toothpaste, and the person controlling the study are blind.
Participants/Inclusion and exclusion criteria
The patient must be aged between 18-75.
The patient must have More than 20 healthy teeth in their mouth.
The patient shouldn't be taking antibiotics or anti-inflammatory drugs continuously.
The patient shouldn't be a smoker.
The patient shouldn't be pregnant, Lactating mother, and with systemic or immunity disorders and diseases.
The patient shouldn't have a restoration, crown, or an unacceptable bridge.
Intervention groups
Intervention group: the group using the Persica-containing toothpaste.
Control group: the group using the Persica-free toothpaste.
Comparative evaluation of the effectiveness of a Persica-containing toothpaste over a Persica-free toothpaste in patients with plaque-induced gingivitis
Public title
Effect of a Persica-containing toothpaste in plaque induced gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18 to 75
The patient must have at least 20 teeth without crown restorations or cavities
Patient of plaque induces gingivitis
BIP positive or a change in gingival margin color
The patient is willing to participate
Exclusion criteria:
The cause of gingivitis isn't plaque
Patient has been taking antibiotics or anti inflammatory drugs repeatedly within the past 3 months
Pregnant or lactating women
Patient with systemic or immunity problems
Smoker
Pocket depth > 4mm
Patient with clinical attachment loss
Patient with not acceptable partial prosthesis, restorations or bridges
Patient using orthodontic appliances
Patient with a history of allergic reactions to chemicals
Patient using mouth rinse
Age
From 18 years old to 75 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randmization: we put people randomly in blocks containing 4 or 6 people. Then half of every block will randomly be in the control and the other half in the intervention
Unit of randomization: personal
Not using layers of randomization
Done by using statical softwares
Allocation: files containing the information will be kept with a person who will not be participating or conducting the study
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study the examiner, analytical counselor, person handing out the toothpastes, patient and the person controlling the study will be blind about which toothpaste is the patient using
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Vice chancellor for research, Tehran University of Medical Sciences
Intervention group: On the first appointment after the clinical periodontal examinations, the patient will receive phase one treatment: Root planing and scaling (SRP), and then will be given a Persica-containing toothpaste (Commercially known as Dentamax herbal toothpaste, Goltash company, Isfahan, Iran) to use twice a day, before sleep and after breakfast, each time in the size of a pea and then brush their teeth using the Rolling method. The patient will also be given dental floss to use after brushing their teeth. later on, the patient will be followed up within a week, two weeks, one month, and two months after the first appointment to record the periodontal indexes. The components of the toothpaste are: Water, Sorbitol, Glycerine, Silica-Ab, Silica-Th, Salvadora Persica extract, S.L.S, C.M.C, NaF, Food Flavoring, C.I.77891, C.I.19140, Caustic soda, Sodium saccharin, Methyl Paraben, Carbomer, C.I.42090
Category
Treatment - Drugs
2
Description
Control group: On the first appointment after the clinical periodontal examinations, the patient will receive phase one treatment: Root planing and scaling (SRP), and then will be given an ordinary toothpaste with similar components as the interventions groups toothpaste but without Persica extract (Goltash company, Isfahan, Iran) to use twice a day, before sleep and after breakfast, each time in the size of a pea and then brush their teeth using the Rolling method. The patient will also be given dental floss to use after brushing their teeth. later on, the patient will be followed up within a week, two weeks, one month, and two months after the first appointment to record the periodontal indexes. The components of the toothpaste are: Water, Sorbitol, Glycerine, Silica-Ab, Silica-Th, S.L.S, C.M.C, NaF, Food Flavoring, C.I.77891, C.I.19140, Caustic soda, Sodium saccharin, Methyl Paraben, Carbomer, C.I.42090
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of dentistry of Tehran university of medical sciences
Full name of responsible person
Neda Moslemi
Street address
North karegar Street, Hakim Hwy
City
Tehran
Province
Tehran
Postal code
5599114399
Phone
+98 21 8801 5950
Email
dentistry@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Goltash company, Paksan
Full name of responsible person
Bahram Khosravi
Street address
7th st, Mobarake, Isfehan
City
Isfehan
Province
Isfehan
Postal code
8173644673
Phone
+98 31 5237 3350
Email
info@goltash.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Goltash company, Paksan
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Houriyeh Radanfar
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 23, Nasr 1 Alley, Shahed Ave,Deh haqi street, South Nabard Blvd, Mahallati Hwy, Tehran
City
Tehran
Province
Tehran
Postal code
1777893556
Phone
+98 21 3631 6736
Email
hradanfar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Neda Moslemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry Faculty, Ghods ave., Keshavarz Blv.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8897 3902
Fax
+98 21 8897 3902
Email
nmoslemi@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Houriyeh Radanfar
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 23, Nasr 1 Alley, Shahed Ave, Deh Haqi Street, South Nabard Blvd, mahallati Hwy, Tehran
City
Tehran
Province
Tehran
Postal code
1777893556
Phone
+98 21 3631 6736
Email
hradanfar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD