Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06051487 |
| Other study ID # |
Dentist |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 11, 2022 |
| Est. completion date |
April 25, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Mansoura University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background The objective of this study was to evaluate the antibacterial effect of Titanium
dioxide nanoparticles incorporated into the acrylic baseplates of maxillary part of twin
block appliances in orthodontic patients during the treatment period.
Material and methods Twenty-six patients were selected randomly and divided into two
groups(n=13). Test group patients were used orthodontic functional appliances containing
Titanium dioxide nanoparticles in acrylic baseplates. Control group patients were used
orthodontic functional appliances without Titanium dioxide nanoparticles in acrylic
baseplates. Swap samples were taken from palatal gingiva facing fitting surface of acrylic
component of maxillary part of twin block appliance for each patient at five times intervals
(base line sample, after one, two, four, and six months) then cultured in blood agar plates
to calculate bacterial colony count.
Description:
Design of the appliance
For all of the chosen patients, the Twin Block, which consists of upper and lower bite
blocks, was constructed. In this study the upper bite block was used. The upper part
incorporates labial bow with U loop around canines and Adam clasps on the upper first molars
for retention. Midline screw may be added to the upper part of the appliance to aid in the
correction of the posterior cross bite if occurred during treatment.
Appliance construction (dental laboratory step) Based on cast models of each patient, acrylic
baseplates for orthodontic appliances were manufactured using auto-polymerizing PMMA resin,
the monomer-to-polymer ratio recommended by the manufacturer, and standard acrylization,
trimming, and finishing-polishing processes The acrylic material used for fabrication of the
appliance was (Acrostone acrylic material, under exclusive liscence, England). The
manufacturer's suggested powder-liquid volume ratio is 3:1 representing 22 g of the polymer
and 10 mL of the liquid monomer. Powder-liquid volume ratio for construction of appliance was
calculated . This created samples were the control group.
Intervention Titanium dioxide nano powder was prepared at City of Scientific Research and
Technological Applications (SRTA-City) in Egypt.
During the appliance containing TiO2 nanoparticles construction, first of all, the calculated
quantity of titanium dioxide nano powder was mixed manually with acrylic resin polymer for 60
s by shaking the powders inside a small container and subsequently, the calculated quantity
of the monomer was added to obtain a PMMA containing TiO2 NPs .This created samples were the
test group. the powder was mixed with the liquid as recommended by the manufacturer, applied
to a mold and flasked. Then the acrylic baseplate was finished and polished.
Clinical step:
The patients were instructed to use the device (twin block) full-time, including while they
slept. The patients were instructed not to use mouthwashes, antibiotics, or xylitol products
during this time but to continue brushing their teeth as usual and eating a normal diet
instead. Prior to sample collection, the patients were told not to brush their teeth or
practise other oral hygiene routines for 24 hours, and they were also told not to eat or
drink for an hour.
Sample:
Swap Samples were taken just before wearing the appliance (base line sample) then at the
following time intervals of wearing appliance for each group (after one month, after
two-months, after four-months, and after six months).
Swap was taken from palatal gingiva facing fitting surface of acrylic baseplate of maxillary
part of twin block appliance for each patient using sterilized cotton swap then placed in 1ml
of broth solution in sterilized tube.
Broth solution (thioglycolate broth) which act as transport media used to refresh bacteria if
it present and preserve it until send to lab.
Sample examination (laboratory step) Sample examination was done in Microbiology Diagnostics
and Infection Control unit (MDICU), Medical Microbiology and Immunology Department, Faculty
of Medicine, Mansoura University.
After sample had been send to the lab, vortex was done for it using Vortex Mixer VM-300 Gemmy
for one or two minute to release all sample from the swap in the solution(1ml). Then swap was
discarded and broth solution was used. We used 10 microns of the solution. it was cultured in
blood agar plate. Solution was placed on the top of the plate using swap, descended on
vertical line in the middle part of the plate then horizontal lines passing through this
vertical line then the plate was placed in the incubator for 24 hours to calculate the colony
forming unit / ml for streptococcus mutans.
