Gingival InflammationNCT06051487
Evaluation of Anti Bacterial Effect of Titanium Dioxide Nanoparticles on Baseplates of Twin Block
A study testing titanium dioxide nanoparticles in test group in people with Gingival Inflammation, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Inflammation
- What is being tested?
- titanium dioxide nanoparticles in test group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Mar 2022to 25 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- early permanent dentition (ages 9 to 14)
- mandibular retrusion-related class II skeletal deformity
- overjet more than 4mm
Who cannot join
- systemic diseases
- congenital craniofacial deformity
- inflammatory or infectious diseases within the previous month
- taking medication in the last month, such as fluoride or antibiotics
- frequent consumers of sorbitol- and xylitol-containing products
- mouth rinses
Show all 9Show fewer
- unusual or specific dietary habits
- cleft lip or palate
- unusual habits or previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Titanium Dioxide Nanoparticles Addition to Acrylic Baseplates of Orthodontic Functional Appliances
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.
Read the detailed 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.
- Conditions
- Gingival Inflammation
- Being tested
- titanium dioxide nanoparticles in test group
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
titanium dioxide nanoparticles in test groupOther
Titanium dioxide nanoparticles added to acrylic baseplate in test group
| Study group | Role | What they receive |
|---|---|---|
| Titanium dioxide nanoparticles containing group | Other | participants using twin block appliance in which titanium dioxide nanoparticles added to acrylic baseplates to evaluate its antibacterial effect Receives: Other: titanium dioxide nanoparticles in test group |
| control | Other | participants use twin block appliance without any addition to acrylic base plates Receives: Other: titanium dioxide nanoparticles in test group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial colony count
Changes in bacterial colony count under acrylic base plate in Participants using twin block appliance containing titanium dioxide nanoparticles in comparison to participant using appliance not containing titanium dioxide nanoparticles
Measured: samples was taken within five time intervals (base line samples, at one month, at two months, at four months, at six months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start11 Mar 2022
- Primary completion11 Oct 2022
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival InflammationStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghada M Elabd, Principal investigator, Master degree student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051487
- Sponsor's protocol ID
- Dentist
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Titanium Dioxide Nanoparticles Addition to Acrylic Baseplates of Orthodontic Functional Appliances
- ClinicalTrials.gov ID
- NCT06051487
- Acronym / sponsor ID
- Dentist
- Conditions
- Gingival Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 11 Oct 2022 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titanium dioxide nanoparticles containing group | Other | Other: titanium dioxide nanoparticles in test groupparticipants using twin block appliance in which titanium dioxide nanoparticles added to acrylic baseplates to evaluate its antibacterial effect |
| control | Other | Other: titanium dioxide nanoparticles in test groupparticipants use twin block appliance without any addition to acrylic base plates |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- early permanent dentition (ages 9 to 14)
- mandibular retrusion-related class II skeletal deformity
- overjet more than 4mm
Key exclusion criteria (9 listed)
- systemic diseases
- congenital craniofacial deformity
- inflammatory or infectious diseases within the previous month
- taking medication in the last month, such as fluoride or antibiotics
- frequent consumers of sorbitol- and xylitol-containing products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| titanium dioxide nanoparticles in test groupTitanium dioxide nanoparticles added to acrylic baseplate in test group | Other | Titanium dioxide nanoparticles containing group, control |
Primary outcome
Bacterial colony count
Time frame: samples was taken within five time intervals (base line samples, at one month, at two months, at four months, at six months)
Changes in bacterial colony count under acrylic base plate in Participants using twin block appliance containing titanium dioxide nanoparticles in comparison to participant using appliance not containing titanium dioxide nanoparticles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghada M Elabd principal investigator
Master degree student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing titanium dioxide nanoparticles in test group in people with Gingival Inflammation, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial colony count (time frame: samples was taken within five time intervals (base line samples, at one month, at two months, at four months, at six months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.