Evaluation of the antibacterial and caries prevention effects of a varnish containing combined nanohydroxyapatite and galla chinensis in fixed orthodontic patients
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General information
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72
72
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2022-10-22, 1401/07/30
2022-10-22 00:00:00
empty
2022-11-20, 1401/08/29
2022-11-20 00:00:00
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2023-07-01, 1402/04/10
2023-07-01 00:00:00
empty
the trial is finished
the trial is finished
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درمان خاتمه یافته است
درمان خاتمه یافته است
Sharing plan
nر صورت تمایل به بخش کتابخانه دانشکده دندانپزشکی شیراز برای
دسترسی به پایان نامه ها مراجعه شود
در صورت تمایل به بخش کتابخانه دانشکده دندانپزشکی شیراز برای
دسترسی به پایان نامه ها مراجعه شود
nردر صورت تمایل به بخش کتابخانه دانشکده دندانپزشکی شیراز برای دسترسی به پایان نامه ها مراجعه شود
Protocol summary
Study aim
Evaluation of one type of varnish in preventing the formation of white spot lesions in patients under Orthodontic treatment
Design
Parallel group, Randomized clinical trial, Double-blind (patient and examiner), 72 patients, Using dynamic randomized block
Settings and conduct
On the day of treatment, the upper jaw's teeth will be dried and isolated, then varnish is applied to the buccal surface of the tooth with a micro brush, after one minute the patient is asked to spit, and this process is repeated every four weeks for 7 months. This process will be done in the orthodontics department of the dentistry school.
Participants/Inclusion and exclusion criteria
Inclusion criteria::
۱. Age range of ۱۴ to ۲۹ years
۲. Absence of any systemic disease
۳. No use of antibiotics or antibacterial mouthwash in the previous month
۴. Periodontal health, absence of current caries or enamel demineralization
۵. All permanent dentition is present up to the first molar.
۶. No history of prior orthodontic or periodontal therapy.
۷. No smoking habit
Exclusion criteria
۱. Visible sign of dental hypo-calcification
۲. Craniofacial anomalies
۳. History of cleft lip and palate deformities
۴. History of dental restorative treatment on the buccal surface
۵. History of long term use of anti-inflammatory drugs
۶. History of glass ionomer dental restorative treatment
Intervention groups
Parallel groups, ranandomized clinincal trial
Main outcome variables
Caries assessment, Evaluation of bacterial count
General information
Reason for update
the trial is finished
Acronym
IRCT registration information
IRCT registration number:IRCT20220907055913N1
Registration date:2022-09-16, 1401/06/25
Registration timing:prospective
Last update:2025-03-01, 1403/12/11
Update count:1
Registration date
2022-09-16, 1401/06/25
Registrant information
Name
Faezeh Bahraini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 3192
Email address
fbahraini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-07, 1401/07/15
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
2022-10-22, 1401/07/30
Actual recruitment end date
2022-11-20, 1401/08/29
Trial completion date
2023-07-01, 1402/04/10
Scientific title
Evaluation of the antibacterial and caries prevention effects of a varnish containing combined nanohydroxyapatite and galla chinensis in fixed orthodontic patients
Public title
Evaluation of caries control effect of a varnish containing combined nanohydroxyapatite and galla chinensis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of 14 to 29 years
Absence of any systemic disease
Periodontal health, absence of current caries or enamel demineralization.
All permanent dentition is present up to the first molar
No history of prior orthodontic or periodontal therapy
No smoking habit
No use of antibiotics or antibacterial mouthwash in the previous month
Exclusion criteria:
Visible sign of dental hypo-calcification
Craniofacial anomalies
History of cleft lip and palate deformities
History of dental restorative treatment on the buccal surface
History of long term use of anti-inflammatory drugs
History of glass ionomer dental restorative treatment
Age
From 14 years old to 29 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
72
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
To balance the age and sex variables, the randomization will be done using block randomization for all participants. https://www.sealedenvelope.com will generate a block randomization list with a ۴-block size. T During the initial bonding appointment, a random code will be given to each patient based on the randomization list by an assistant who is not directly involved in the study. Groups I and II will include subjects using GCE/n-HA varnish (test) and placebo varnish (negative control) respectivel
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and orthodontist will be blinded to the type of varnish used. In this regard, the varnish bottles’ shapes will be similar and labeled as 1 and 2 by a person not involved in this study
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
caries assessment(florescent and visual assesment)
Timepoint
Initial values (T۰) ,۱ months(T۱), ۴ months(T۲) , ۷ months(T۳) of use of various anti-demineralizing agents
Method of measurement
1. Visual assessment: All measures will be taken by the same examiner, who is calibrated before the research. Before bonding, the initial visual assessment will be done. The international caries detection and assessment system II (ICDAS II) will be used to inspect and record the buccal surfaces of the test subjects' teeth at each visit. After ۵ seconds of compressed air drying on the tooth surfaces, the examination will be done. The evaluation will be conducted with the use of a mouth mirror and a blunt probe under clinical illumination in accordance with the ICDAS II index criteria. The mean scores of all ۱۰ maxillary teeth involved in the research will be computed for each patient, and a mean reading number will be recorded. 2. Florescent assessment: The teeth will be scanned carefully by the same dentist blinded as to group allocation of the subjects using probe tip B held in contact with the tooth surface and tilted around the measuring site rocking slowly in a pendulous motion so that fluorescence can be collected from all directions at 4 labial sites on the enamel (gingival, occlusal, mesial, and distal) around the brackets. The peak reading displayed on the panel of the DIAGNOdent pen during the scan will be recorded for each site of the tooth surface. Then the mean of 4 sites for each tooth will be calculated and recorded. For each patient, the mean scores of all 10 maxillary teeth included in the study will be calculated and a mean Diagnodent reading number for each patient will be recorded.
Secondary outcomes
1
Description
bactreial colony count
Timepoint
plaque sampling and bacterial culturing will be done at the following time intervals: Initial values (T0) ,1 months(T1), 4 months(T2) , 7 months(T3) of use of various anti-demineralizing agents
Method of measurement
On the day of the appointment, the patient will be refrained from eating or brushing their teeth. Ligatures and archwires will be carefully removed at each appointment. The collecting sites will be gently air dried after being isolated of the excess water and saliva with cotton rolls. Plaque samples will be collected using a sterile cotton swab from the labial surfaces of the considered teeth.By moving the tip of the sterile cotton swab along the occlusal, mesial, gingival, and distal edges of the bracket base, and while holding the tip in constant contact with the tooth surface adjacent to the base of bracket, dental plaque will be collected. Sterile cotton swabs will be rapidly transferred to the samples transport media (thioglycolate broth carrier medium) and to anaerobic bacteria culture media. Microbial samples will be cultivated and analyzed by the same examiner in the Department of Clinical Microbiology of Shiraz University of Medical Sciences. According to G. WESTERGREN AND B. KRASSE, the sample will be cultured.
Intervention groups
1
Description
Control group: Placebo Varnish
Category
Placebo
2
Description
Intervention group: varnish combined galla chinensis(GCE) and nano hydroxyapatite(HA). HA ( Ca10(Po4) 6(OH)2 , white powder , size of nano particles < 20 nm ) will be prepared by APATECH (Yazd, Yazd Science and Technology park, Iran). The varnish base will be prepared by mixing hydrogenerated rosin with absolute ethanol at a 3:1 (W/W) ratio in a closed vessel on a stirrer at room temperature for 24hours. 4000 ppm of galla chinensis and 10 % (W%) nano-HA will be added to the varnish base (hydrogenerated rosin (50% W) with absolute ethanol (35% W) ) for GCE/nano-HA varnish production. Varnish application will be done at the first session and then every month untill 7 month.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
orthodontic departman of dentistry school of Shiraz univesity of medical sciences
Full name of responsible person
Shabnam Ajami
Street address
Orthodontic department, School of Dentistry, Qom Abad, Qasrodasht Ave
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
dr.ajami.sh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpoor
Street address
School of Dentistry, Qom Abad, Qasrodasht َAve
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
Dental@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Shabnam Ajami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Orthodontic department, School of Dentistry, Qom Abad, Qasrodasht Ave
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
dr.ajami.sh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shabnam Ajami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Orthodontic department, School of Dentistry, Qom Abad, Qasrodasht Ave
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
dr.ajami.sh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Faezeh Bahraini
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Orthodontic department, School of Dentistry, Qom Abad, Qasrodasht Ave
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
faezeh_bahraini@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of data such as information about the main outcome can be shared
When the data will become available and for how long
Start of access 6 months after publishing of the results
To whom data/document is available
Our data will be accessible only to higher education researchers.
Under which criteria data/document could be used
If data needs authentication for further studies, writers will be accessible
From where data/document is obtainable
For further information , please contact Shiraz University of Medical Science (SUMS) , please.
What processes are involved for a request to access data/document
Further questions will be responded at the library.sums.ac.ir