Dental MalocclusionNCT05151991

A Clinical Trial on the Failure Rates of Metallic and Ceramic Orthodontic Brackets

A study testing Fixed orthodontic treatment with stainless steel brackets and Fixed orthodontic treatment with ceramic brackets in people with Dental Malocclusion, run by University of Pavia at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to assess if there are significant differences in the failure rate of stainless steel and ceramic brackets. For this study, patients will be enrolled and divided into two groups, according to the type of brackets (stainless steel or ceramic) used for orthodontic treatment. Read more about this study

Who is it for?: Any age
Conditions the study is for: Dental Malocclusion
What is being tested?: Fixed orthodontic treatment with stainless steel brackets and Fixed orthodontic treatment with ceramic brackets
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteItaly
Study dates: 9 Dec 2021to 8 May 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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

patients willing to begin fixed multibracket therapy with metallic or ceramic brackets;
full permanent dentition;
enamel integrity, absence of traumatic or carious lesions, no pretreatment procedure performed with chemical agents;
no previous orthodontic treatment with fixed vestibular appliances.

Who cannot join

patients suffering from systemic diseases;
patients taking medications that could alter periodontal conditions (NSAIDS, steroids, etc.);
patients with low compliance;
patients unable to give informed consent;
presence of congenital enamel defects;
extractions for orthodontic reasons;
oral/orthognathic surgery.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100

Other trials in Italy

About this study

Official title: A 12-months Evaluation of the Failure Rates of Stainless Steel and Ceramic Brackets in Orthodontic Fixed Therapy: a Clinical Trial.

Read the detailed description

This clinical trial aims to investigate if there are differences in the failure rates of stainless steel and ceramic orthodontic brackets. Patients willing to start orthodontic fixed therapy and recruited for the study will be asked to sign the informed consent. Parents will sign the consent for underage patients. After that, patients will be divided into two groups:

Group MET: stainless steel brackets will be bonded on the vestibular surfaces of teeth.
Group CER: ceramic brackets will be bonded on the vestibular surfaces of teeth. The following sequence of archwires will be adopted for the first six months: 0.012-in Niti, 0.014-in Niti, 0.016-in NiTi, 0.018 SS Australian, 0.020 SS Australian, 0.017X0.025-in NiTi, 0.019X0.025-in SS. The failure rates of the brackets will be recorded each month for 12 months. Each failed bracket will be recorded once. For each patient, pre-treatment lateral cephalometric radiograph and study models will be used to measure ANB angle, Wits, Skeletal Class, dento-alveolar discrepancy and Little Index at the beginning of the treatment. Bond failures will be recorded together with the archwire engaged at the moment of the failure.

Sample size Sample size was calculated with the following assumptions: ability to detect a clinically relevant difference of 4.935% in the failure rates (primary outcome) of the two groups with an alfa = 0.05 and power = 80%. The assumptions were based on findings of a previous study with an expected value of 12.08% for the first group at the end of 12 months of therapy. Therefore, 800 brackets (40 patients) per group were required for the study.

Statistical analysis Statistical analysis will be conducted with R software (R version 3.1.3, R Development Core Team, R Foundation for Statistical Computing, Wien, Austria). Fisher exact test will be performed to evaluate the differences between the failure rates of the two groups, between anterior and posterior sites and between upper and lower arches. Kaplan-Meier survival analysis of the bond failures will be performed among the 12 months of the study. Linear regressions will be calculated to assess the effects on bond failure of the skeletal and dental variables collected before the bonding procedure. Significance for all statistical tests will be predetermined at P<0.05.

Conditions: Dental Malocclusion
Being tested: Fixed orthodontic treatment with stainless steel brackets, Fixed orthodontic treatment with ceramic brackets
Keywords: metallic brackets, ceramic brackets, bond failures, multibrackets therapy, orthodontic treatment, bonding
Medical subject headings: Malocclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fixed orthodontic treatment with stainless steel bracketsOther
Orthophosphoric acid 37% acid (Gerhò Etchant gel 37%, Gerhò spa, Terlano, Italy) will be applied for 30 s for the etching of the vestibular surfaces of teeth. The, after rinsing and drying, a thin layer of Transbond XT Light Cure Adhesive Primer (3M Unitek, Monrovia, CA, USA) will be applied and then cured for 10 s with a LED unit. At last, Transbond XT Light Cure Adhesive Paste (3M Unitek) will be applied on the base of stainless steel brackets (Queen Series Low Profile Brackets MBT 0.022", Aestetika, Terni, TR, Italy); brackets will be applied on the vestibular surfaces of teeth with a light pressure and the extra paste will be removed. Curing will be performed with the LED unit at 2 mm distant from the enamel-bracket interface for 40 s, 10 s per each surface (mesial, distal, gingival and occlusal). The following sequence of archwires will be adopted for the first six months: 0.012-in Niti, 0.014-in Niti, 0.016-in NiTi, 0.018 SS, 0.020 SS, 0.017X0.025-in NiTi, 0.019X0.025-in SS.
Fixed orthodontic treatment with ceramic bracketsOther
Orthophosphoric acid 37% acid (Gerhò Etchant gel 37%, Gerhò spa, Terlano, Italy) will be applied for 30 s for the etching of the vestibular surfaces of teeth. The, after rinsing and drying, a thin layer of Transbond XT Light Cure Adhesive Primer (3M Unitek, Monrovia, CA, USA) will be applied and then cured for 10 s with a LED unit. At last, Transbond XT Light Cure Adhesive Paste (3M Unitek) will be applied on the base of ceramic brackets; brackets (Super Clear Series Brackets MBT 0.022", Aestetika, Terni, TR, Italy) will be applied on the vestibular surfaces of teeth with a light pressure and the extra paste is removed. Curing will be performed with the LED unit at 2 mm distant from the enamel-bracket interface for 40 s, 10 s per each surface (mesial, distal, gingival and occlusal). Then, the following sequence of archwires will be adopted for the first six months: 0.012-in Niti, 0.014-in Niti, 0.016-in NiTi, 0.018 SS, 0.020 SS, 0.017X0.025-in NiTi, 0.019X0.025-in SS

Study groups in NCT05151991
Study group	Role	What they receive
Groups MET	Active comparator	Patients from this group will undergo orthodontic fixed treatment with stainless steel brackets. Receives: Other: Fixed orthodontic treatment with stainless steel brackets
Group CER	Active comparator	Patients from this group will undergo orthodontic fixed treatment with ceramic brackets. Receives: Other: Fixed orthodontic treatment with ceramic brackets

What is being measured

The primary outcome is the main question the study is designed to answer.

Failure rates of metallic and ceramic brackets.
Each month, failed brackets will be recorded. Per each tooth, failure will be recorded once.
Measured: Among the 12 months of the study.

Secondary outcomes (6)

Failure rates of metallic and ceramic brackets per sites and sides.
Failures will be divided in "anterior" for brackets failed on incisors and canines, and "posterior" for premolar brackets. Failure will be recorded per dental arch ("upper" and "lower") and per archwire (.014-in NiTi, .016-in NiTi, .017X0.25-in NiTi, .019X.025-in SS). Per each tooth, failure will be recorded once.
Measured: Among the 12 months of the study.
ANB angle
ANB angle will be calculated using the pre-treatment lateral cephalometric radiograph.
Measured: Before the beginning of the orthodontic treatment.
Wits Index
Wits Index will be calculated using the pre-treatment lateral cephalometric radiograph.
Measured: Before the beginning of the orthodontic treatment.
Skeletal Class
Skeletal Class will be assessed using ANB angle and Wits Index will be calculated using the pre-treatment lateral cephalometric radiograph.
Measured: Before the beginning of the orthodontic treatment.
Dento-alveolar discrepancy
Dento-alveolar discrepancy will be calculated using the pre-treatment study models.
Measured: Before the beginning of the orthodontic treatment.
Little Index
Little Index will be calculated using the pre-treatment study models.
Measured: Before the beginning of the orthodontic treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 20218 May 2023

First posted9 Dec 2021
Study start9 Dec 2021
Primary completion4 May 2023
Study completion8 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dental MalocclusionStudies of the same condition, open and under way.
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: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05151991
Sponsor's protocol ID: 2021-METCERORTO
Status last verified: Jan 2024
First submitted: 10 Nov 2021
Last updated: 17 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data will be available upon motivated request to Principal Investigator

Publications

Kirschneck C, Rohn C, Proff P, Reicheneder C. Influence of enamel sealing with a light-cured filled sealant before bracket bonding on the bond failure rate during fixed orthodontic therapy. J Orofac Orthop. 2019 May;80(3):136-143. doi: 10.1007/s00056-019-00174-w. Epub 2019 Apr 10.
PubMed 30972424

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children

All Dental Malocclusion trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-months Evaluation of the Failure Rates of Stainless Steel and Ceramic Brackets in Orthodontic Fixed Therapy: a Clinical Trial.
ClinicalTrials.gov ID: NCT05151991
Acronym / sponsor ID: 2021-METCERORTO
Conditions: Dental Malocclusion
Keywords: metallic brackets, ceramic brackets, bond failures, multibrackets therapy, orthodontic treatment, bonding
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: University of PaviaUniversity, hospital or other
Study start: 9 Dec 2021 (actual)
Primary completion: 4 May 2023 (actual)
Study completion: 8 May 2023 (actual)
First posted: 9 Dec 2021 (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.

Detailed description

Group MET: stainless steel brackets will be bonded on the vestibular surfaces of teeth.
Group CER: ceramic brackets will be bonded on the vestibular surfaces of teeth. The following sequence of archwires will be adopted for the first six months: 0.012-in Niti, 0.014-in Niti, 0.016-in NiTi, 0.018 SS Australian, 0.020 SS Australian, 0.017X0.025-in NiTi, 0.019X0.025-in SS. The failure rates of the brackets will be recorded each month for 12 months. Each failed bracket will be recorded once. For each patient, pre-treatment lateral cephalometric radiograph and study models will be used to measure ANB angle, Wits, Skeletal Class, dento-alveolar discrepancy and Little Index at the beginning of the treatment. Bond failures will be recorded together with the archwire engaged at the moment of the failure.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Groups MET	Active comparator	Other: Fixed orthodontic treatment with stainless steel bracketsPatients from this group will undergo orthodontic fixed treatment with stainless steel brackets.
Group CER	Active comparator	Other: Fixed orthodontic treatment with ceramic bracketsPatients from this group will undergo orthodontic fixed treatment with ceramic brackets.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

patients willing to begin fixed multibracket therapy with metallic or ceramic brackets;
full permanent dentition;
enamel integrity, absence of traumatic or carious lesions, no pretreatment procedure performed with chemical agents;
no previous orthodontic treatment with fixed vestibular appliances.

Key exclusion criteria (7 listed)

patients suffering from systemic diseases;
patients taking medications that could alter periodontal conditions (NSAIDS, steroids, etc.);
patients with low compliance;
patients unable to give informed consent;
presence of congenital enamel defects;

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
Fixed orthodontic treatment with stainless steel bracketsOrthophosphoric acid 37% acid (Gerhò Etchant gel 37%, Gerhò spa, Terlano, Italy) will be applied for 30 s for the etching of the vestibular surfaces of teeth. The, after rinsing and drying, a thin layer of Transbond XT Light Cure Adhesive Primer (3M Unitek, Monrovia, CA, USA) will be applied and then cured for 10 s with a LED unit. At last, Transbond XT Light Cure Adhesive Paste (3M Unitek) will be applied on the base of stainless steel brackets (Queen Series Low Profile Brackets MBT 0.022", Aestetika, Terni, TR, Italy); brackets will be applied on the vestibular surfaces of teeth with a light pressure and the extra paste will be removed. Curing will be performed with the LED unit at 2 mm distant from the enamel-bracket interface for 40 s, 10 s per each surface (mesial, distal, gingival and occlusal). The following sequence of archwires will be adopted for the first six months: 0.012-in Niti, 0.014-in Niti, 0.016-in NiTi, 0.018 SS, 0.020 SS, 0.017X0.025-in NiTi, 0.019X0.025-in SS.	Other	Groups MET
Fixed orthodontic treatment with ceramic bracketsOrthophosphoric acid 37% acid (Gerhò Etchant gel 37%, Gerhò spa, Terlano, Italy) will be applied for 30 s for the etching of the vestibular surfaces of teeth. The, after rinsing and drying, a thin layer of Transbond XT Light Cure Adhesive Primer (3M Unitek, Monrovia, CA, USA) will be applied and then cured for 10 s with a LED unit. At last, Transbond XT Light Cure Adhesive Paste (3M Unitek) will be applied on the base of ceramic brackets; brackets (Super Clear Series Brackets MBT 0.022", Aestetika, Terni, TR, Italy) will be applied on the vestibular surfaces of teeth with a light pressure and the extra paste is removed. Curing will be performed with the LED unit at 2 mm distant from the enamel-bracket interface for 40 s, 10 s per each surface (mesial, distal, gingival and occlusal). Then, the following sequence of archwires will be adopted for the first six months: 0.012-in Niti, 0.014-in Niti, 0.016-in NiTi, 0.018 SS, 0.020 SS, 0.017X0.025-in NiTi, 0.019X0.025-in SS	Other	Group CER

Primary outcome

Failure rates of metallic and ceramic brackets.
Time frame: Among the 12 months of the study.
Each month, failed brackets will be recorded. Per each tooth, failure will be recorded once.

6 secondary outcomes

Failure rates of metallic and ceramic brackets per sites and sides.
Time frame: Among the 12 months of the study.
ANB angle
Time frame: Before the beginning of the orthodontic treatment.
Wits Index
Time frame: Before the beginning of the orthodontic treatment.
Skeletal Class
Time frame: Before the beginning of the orthodontic treatment.
Dento-alveolar discrepancy
Time frame: Before the beginning of the orthodontic treatment.
Little Index
Time frame: Before the beginning of the orthodontic treatment.

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 17 Jan 2024.
Background: PubMed 30972424Kirschneck C, Rohn C, Proff P, Reicheneder C. Influence of enamel sealing with a light-cured filled sealant before bracket bonding on the bond failure rate during fixed orthodontic therapy. J Orofac Orthop. 2019 May;80(3):136-143. doi: 10.1007/s00056-019-00174-w. Epub 2019 Apr 10.
Individual participant dataSharing planned: No. Data will be available upon motivated request to Principal Investigator

Related trials for Dental Malocclusion

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children

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.

Andrea Scribante, DDS, PhD principal investigator

University of Pavia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 7 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 17 Jan 2024. 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 Italy. 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?

Failure rates of metallic and ceramic brackets. (time frame: Among the 12 months of the study.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05151991, which also lists 1 linked publication.

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 17 Jan 2024.