Protocol summary
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Study aim
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evaluation of the effect of coating thermoplastic retainers with titanium dioxide nanoparticles on Streptococcus mutans count
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Design
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Split-mouse clinical trial on orthodentic patients in the final phase of treatment who are candidates for thermoplastic retainer. With control group, double-blind and randomized method without placement in three phases (days zero, 7 and 30) on 32 patients
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Settings and conduct
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Due to the antibacterial activity of titaniom dioxie ion, plaque specimens will be collected with sterile swabs from 1 to 2 mm of gingival margin and enamel surface of central incisors .Total living colonies of S. mutans will be counted. After 7 and 30 days of using retainers, re-sampling of the mentioned areas is done . Patients and laboratory technicians are not awar of the status of retainers. The study is performed in Hamadan Dental School.
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Participants/Inclusion and exclusion criteria
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Inclusion conditions:15 to 30 years old age,no use of antibiotics or antibacterial mouthwashes during maintenance and pretreatment,no history of systemic and periodontal disease,use of thermoplastic retainers Exclusion conditions:Caries requires repair,having dentures, presence of craniofacial anomalies.
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Intervention groups
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At the end of orthodontic treatment, in 32 patients, a clear retainer made out of thermoplastic sheets (United Kingdom, DB lab) in the upper and lower jaw is used. One of the retainers in the upper or lower jaw is covered with 50 µg titanium dioxide nanoparticles (Sigma (Aldrich, USA) which has antibacterial activity as an intervention group and the opposite jaw of the same patient is considered as a control.All participants will be given standard oral hygiene training within 10 minutes prior to delivery of retainers .To count the bacteria from patients' teeth, participants will use retainers permanently for a month.
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Main outcome variables
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Number of bacterial colonies
General information
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Reason for update
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registration of study actual time and end of clinical trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210305050580N1
Registration date:
2021-06-18, 1400/03/28
Registration timing:
prospective
Last update:
2024-05-20, 1403/02/31
Update count:
1
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Registration date
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2021-06-18, 1400/03/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-04-19, 1400/01/30
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Expected recruitment end date
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2021-05-20, 1400/02/30
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Actual recruitment start date
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2021-07-06, 1400/04/15
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Actual recruitment end date
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2021-08-21, 1400/05/30
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Trial completion date
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2021-09-21, 1400/06/30
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Scientific title
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Evaluation of the effect of coating thermoplastic retainers with titanium dioxide nanoparticles on the counting of Strepococcus mutans: a split mouth randomized clinical trial
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Public title
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evaluation of the effect of coated retainer on Strepococcus mutans
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age range 15 to 30 years
Do not use antibiotics and antibacterial mouthwashes during retention phase and before treatment
No history of systemic and periodontal diseases
use thermoplastic retainer
Exclusion criteria:
Caries needs repair
Smoking
Having dentures
Presence of cranio-facial anomalies
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Age
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From 15 years old to 30 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
32
More than 1 sample in each individual
Number of samples in each individual:
6
On day 0, 7 and 30, swab sampling is done from the upper and lower jaws of patients, so a total of 6 samples will be taken from each person
Actual sample size reached:
31
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Thirty-two patients are enrolled in the study, each receiving a standard retainer in one jaw and a coated retainer in the opposite jaw.To remove the confounding agents, 16 patients receive a coated retainer in the maxilla and a normal retainer in the mandible, and another 16 patients receive the retainers in reverse. 16 red spheres as representative of the intervention group in the maxilla and 16 blue spheres as representatives of the intervention in the mandible is placed in a container and are selected at random. For the patients 1 to 32, balls are selected randomly from the container in which after removing each ball, they are not entered to the container again.it is expected that after the end of the balls selection, 16 patients will have coated retainer in upper jaw and 16 patients will have coated retainer in lower jaw.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Because the retainers are the same, patients are not aware that which jaw is covered. The technician who counts the bacteria is also unaware of this
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-02-27, 1399/12/09
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Ethics committee reference number
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IR.UMSHA.REC.1399.1038
Health conditions studied
1
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Description of health condition studied
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Dental caries prevention
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ICD-10 code
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K02
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ICD-10 code description
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Dental caries
Primary outcomes
1
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Description
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Counting Streptococcus mutans
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Timepoint
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Count the number of Streptococcus mutans before delivery of retainers and 7 and 30 days later
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Method of measurement
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Counting of samples by serial dilution in the laboratory after bacterial culture
Secondary outcomes
1
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Description
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Release of titanium nitrate in saliva
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Timepoint
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Before delivery of the retainer, day 7 and day 30
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Method of measurement
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With the help of ICP-OES device (710-ES Varian, Australia)
Intervention groups
1
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Description
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Intervention group: Patients who have reached debonding stage and are ready to receive thermoplastic retainer are included in the study. In order to coat the surface of the retainers sheets, we use the spin coating method and TEOS to deposit the synthesized titanium dioxide nanoparticles at a rate of 50 on the sheet. In the next step, we use the thermal technique to stabilize the layer of titanium dioxide on the surface of the retainer. The coated sheets are then placed on each patient's cast with the help of a vacuum former machine to take the shape of the teeth. After removing the sheet additions, the retainer is polished and is ready for delivery to the patient on the same day. All patients are given occupational hygiene instructions on the model (toothbrush and floss). The patient should use the retainers 24 hours a day, except time of feeding for 30 days.Before delivery of the retainers and on the 7th and 30th day, samples are taken from the patient's anterior teeth and sent to the bacteriological laboratory to count the bacteria.
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Category
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Prevention
2
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Description
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Control group: Patients who have reached debonding stage and are ready to receive thermoplastic retainer are included in the study.The regular sheets are then placed on each patient's cast with the help of a vacuum former machine to take the shape of the teeth.After removing the sheet additions, the retainer is polished and given for simultaneous delivery to patients who have received the coated retainer one opposite jaw. All patients are given occupational hygiene instructions on the model (toothbrush and floss). The patient should use the retainers 24 hours a day, except time of feeding for 30 days.Before delivery of the retainers and on the 7th and 30th day, samples are taken from the patient's anterior teeth and sent to the bacteriological laboratory to count the bacteria.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available