Investigating the effect of Hanzal plant extract and Kambouze extract available in the market on the strength of teeth of different people in the age group of 25 to 60 years.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 10 patients. The rand function of Excel software was used for randomization.
Settings and conduct
A series of people with damaged enamel will be selected preferably in the university environment, but they have no knowledge about the type of plant extract or placebo salt serum.
Participants/Inclusion and exclusion criteria
Healthy people whose only tooth enamel is damaged and who do not have any oral and dental diseases, digestion and cancer.
Intervention groups
Plant fruit extract and water are two intervention groups.
Main outcome variables
restoration of tooth enamel; Strengthening the root of the tooth; Teeth whitening.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240505061655N1
Registration date:2024-07-05, 1403/04/15
Registration timing:retrospective
Last update:2024-07-05, 1403/04/15
Update count:0
Registration date
2024-07-05, 1403/04/15
Registrant information
Name
Mandana Behbahani
Name of organization / entity
The University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3793 4327
Email address
ma_behbahani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
Expected recruitment end date
2024-07-05, 1403/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The use of plant extract of unripe melon fruit (Cucumis melo) to restore tooth enamel
Public title
Using the fruit extract of the unripe melon plant to restore tooth enamel
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients whose tooth enamel is damaged
Exclusion criteria:
Age
From 25 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Volunteers in this study are people who refer to the Medical Dental Clinic of Isfahan University. These people have broken or damaged teeth in the upper or lower canine and are in the age range of 25 to 60 years.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the fruit extract of the plant will be provided to the participants and they will be asked to use it as a dropper several times a day to repair their teeth.But the type of plant will not be explained to them.
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University
Street address
Department of Biotechnology, Faculty of Biological Science and Technology, University of Isfahan, Isfahan 81746-73441, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Approval date
2024-05-01, 1403/02/12
Ethics committee reference number
1403.034
Health conditions studied
1
Description of health condition studied
Tooth enamel damage or fracture
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Restoration of damaged tooth enamel
Timepoint
20 days and 40 days
Method of measurement
Imaging of tooth enamel and observation
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: at least 10 people with damaged enamel are selected. Selected people in this group will be given 100 cc of solution containing 10 mg/ml of plant extract and their teeth will be photographed for 40 days every week.
Category
Treatment - Drugs
2
Description
The second intervention group: 10 people with damaged enamel are selected as a placebo control. The selected people in this group will be given 100 cc of physiological serum and their teeth will be photographed for 40 days every week.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Esfahan
Full name of responsible person
Mandana Behbahani
Street address
Department of Biotechnology, Faculty of Biological Science and Technology, University of Isfahan, Isfahan 81746-73441
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 31 3793 4327
Email
ma_behbahani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Esfahan
Full name of responsible person
Mandana Behbahani
Street address
Department of Biotechnology, Faculty of Biological Science and Technology, University of Isfahan, Isfahan 81746-73441, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 31 3793 4327
Email
ma_behbahani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mandana Behbahani, prof, Isfahan University
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Mandana Behbahani
Position
Professor in University of Isfahan
Latest degree
Ph.D.
Other areas of specialty/work
Genetic engineering and molecular biology
Street address
Department of Biotechnology, Faculty of Biological Science and Technology, University of Isfahan, Isfahan 81746-73441, Iran
City
University of Isfahan
Province
University of Isfahan
Postal code
81746-73441
Phone
+98 31 3793 4327
Email
ma_behbahani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Mandana Behbahani
Position
Professor in University of Isfahan
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and molecular genetic engineering
Street address
Department of Biotechnology, Faculty of Biological Science and Technology, University of Isfahan, Isfahan 81746-73441
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 31 3793 4327
Email
ma_behbahani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Mandana Behbahani
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
PhD in genetic engineering and molecular biology
Street address
Department of Biotechnology, Faculty of Biological Science and Technology, University of Isfahan, Isfahan 81746-73441
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 31 3793 4327
Email
ma_behbahani@yahoo.com
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