Orthodontic Appliance ComplicationfailurerateNCT05766033
Bracket Failure With a Novel Etchant Paste. A Randomized Clinical Trial
A study testing Enamel conditioning with a novel etchant paste in people with Orthodontic Appliance Complication, run by University of Baghdad at 1 site in Iraq.
Trial summary
To investigate metallic brackets failure rate bonded post enamel conditioning with a novel CaP etchant paste in comparison with those bonded following conventional enamel etching with PA gel over a period of 6 months. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Enamel conditioning with a novel etchant paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIraq
- Study dates
- 2 Jun 2022to 30 Oct 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Full permanent dentition including incisors, canines, premolars, and first molars.
- Teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide.
- No previous orthodontic treatment with fixed appliances.
Who cannot join
- Were unable to give informed consent) Had craniofacial anomalies.
- Required orthognathic surgery as part of their treatment.
- Had congenital enamel defects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bracket Failure Rate With a Novel Etchant Paste. A Randomized Clinical Trial
To investigate metallic brackets failure rate bonded post enamel conditioning with a novel CaP etchant paste in comparison with those bonded following conventional enamel etching with PA gel over a period of 6 months.
Read the detailed description
Acid etching of tooth surfaces to promote the bonding of orthodontic attachments to the enamel has been a routine procedure in orthodontic treatment since the 1960s. Various types of orthodontic etchants and etching techniques have been introduced in the past five decades. Michael G Buonocore in revolutionized dentistry with his historical paper: "A simple method of increasing the adhesion of acrylic filling materials to enamel surfaces" depicting the advantage of etching and bonding of acrylic to enamel. It forever changed the practice of dentistry. Buonocore and Silverstone led the profession in acid etching and bonding of resin to etched enamel surfaces. These developments allowed orthodontists to bond brackets reliably and apply forces to move teeth without banding every tooth or having brackets deboned. Buonocore reported that 85% phosphoric acid etchant significantly increased the adhesion of acrylic resin to enamel. Since then, a variety of etchants have been used with different concentrations and etching times. These include hydrofluoric acid, citric acid, hydrochloric acid, maleic acid, nitric acid, and phosphoric acid in a variety of concentrations. Suggested etching times can vary from 15 to 60 seconds. The tooth enamel surface is known for its low-energy and hydrophobic properties, with its outermost layer being rich in fluoride. Enamel etching with phosphoric acid (PA) removes the fluoride-rich layer, dissolves enamel mineral, creates micro- pores, and renders a high-energy and hydrophilic enamel surface to permit wetting by an adhesive; yet at the expense of increased surface porosity, susceptibility to staining, caries, more remnant adhesive and enamel loss. Fixation of brackets to teeth involves joining of two different solid substrates or adherents through an intervening adhesive layer. Bracket bases are currently provided with mesh designs that ensure robust mechanical interlocking between the bracket and adhesive, whilst research is ongoing to improve enamel conditioning strategies that can attain clinically successful bond strengths yet maintain an unblemished enamel surface. Alternative methods to conventional enamel etching with phosphoric acid have been sought aiming at decreasing the bond strength to reduce the incidence of enamel damage. The use of glass ionomer cements for orthodontic bonding decreased the occurrence of enamel damage, yet at the expense of clinically unacceptable bond strengths. On the other hand, the use of laser etching and self- etch primers resulted in bracket shear bond strengths comparable to the conventional etch-and-rinse approach, but could not eliminate enamel damage. In 2019, Ibrahim et al developed a new bioactive orthodontic etchant paste made of calcium-phosphate (CaP), which could alleviate subsurface enamel demineralization in comparison with the traditional phosphoric acid etchant and the pre-clinical viability assessment using in vitro studies showed exemplary advantages. The new low-pH CaP paste etchant application is a clinically viable bracket bonding method with steps similar to PA application that yielded adequate bond strength with the advantages of minimal adhesive remnants and no enamel chipping or cracking on deboning of the bracket.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Enamel conditioning with a novel etchant paste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enamel conditioning with a novel etchant pasteOther
Also called Etching for enamel for bracket bonding
The maxillary and mandibular incisors, canines, and premolars for each patient will be conditioned using the Novel etchent paste on one side (experimental), while the other side (control) conditioned with a phosphoric acid gel 37% . Both systems use identical brackets and adhesive system (differ only with regard to the etching system).
| Study group | Role | What they receive |
|---|---|---|
| Novel etchent paste | Experimental | Not described Receives: Other: Enamel conditioning with a novel etchant paste |
| Phosphoric acid 37% | Active comparator | Not described Receives: Other: Enamel conditioning with a novel etchant paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bracket failure rate
Patients with repeated bond failures caused by habits or trauma would be excluded from further analysis.only counting the number of brackets that broken .
Measured: 6 months
Secondary outcomes (1)
Adhesive remenant index
Assessment of the amount of remnant adhesive left post bracket failure (for both methods).This index system was developed on the basis of a pilot study of 20 extracted teeth and the criteria were as follows: score 0 = no adhesive left on the tooth; score 1 = less than half of the adhesive left on the tooth; score 2 = more than half of the adhesive left on the tooth; and score 3 = all adhesive left on the tooth with a distinct impression of the bracket mesh.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start2 Jun 2022
- Primary completion28 Feb 2023
- Study completion30 Oct 2023 (estimated)
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 Orthodontic Appliance ComplicationStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-center, single-operator, split-mouth randomized controlled trial with a 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Qays Aswad, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766033
- Sponsor's protocol ID
- Bracket failure rate
- Acronym
- failurerate
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: till now there is no plan to share it when i found it i will updated it.
Publications
Ibrahim AI, Al-Hasani NR, Thompson VP, Deb S. Resistance of bonded premolars to four artificial ageing models post enamel conditioning with a novel calcium-phosphate paste. J Clin Exp Dent. 2020 Apr 1;12(4):e317-e326. doi: 10.4317/jced.56764. eCollection 2020 Apr.
PubMed 32382380
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bracket Failure Rate With a Novel Etchant Paste. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05766033
- Acronym / sponsor ID
- failurerate / Bracket failure rate
- Conditions
- Orthodontic Appliance Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 13 Mar 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.
To investigate metallic brackets failure rate bonded post enamel conditioning with a novel CaP etchant paste in comparison with those bonded following conventional enamel etching with PA gel over a period of 6 months.
Detailed description
Acid etching of tooth surfaces to promote the bonding of orthodontic attachments to the enamel has been a routine procedure in orthodontic treatment since the 1960s. Various types of orthodontic etchants and etching techniques have been introduced in the past five decades. Michael G Buonocore in revolutionized dentistry with his historical paper: "A simple method of increasing the adhesion of acrylic filling materials to enamel surfaces" depicting the advantage of etching and bonding of acrylic to enamel. It forever changed the practice of dentistry. Buonocore and Silverstone led the profession in acid etching and bonding of resin to etched enamel surfaces. These developments allowed orthodontists to bond brackets reliably and apply forces to move teeth without banding every tooth or having brackets deboned. Buonocore reported that 85% phosphoric acid etchant significantly increased the adhesion of acrylic resin to enamel. Since then, a variety of etchants have been used with different concentrations and etching times. These include hydrofluoric acid, citric acid, hydrochloric acid, maleic acid, nitric acid, and phosphoric acid in a variety of concentrations. Suggested etching times can vary from 15 to 60 seconds. The tooth enamel surface is known for its low-energy and hydrophobic properties, with its outermost layer being rich in fluoride. Enamel etching with phosphoric acid (PA) removes the fluoride-rich layer, dissolves enamel mineral, creates micro- pores, and renders a high-energy and hydrophilic enamel surface to permit wetting by an adhesive; yet at the expense of increased surface porosity, susceptibility to staining, caries, more remnant adhesive and enamel loss. Fixation of brackets to teeth involves joining of two different solid substrates or adherents through an intervening adhesive layer. Bracket bases are currently provided with mesh designs that ensure robust mechanical interlocking between the bracket and adhesive, whilst research is ongoing to improve enamel conditioning strategies that can attain clinically successful bond strengths yet maintain an unblemished enamel surface. Alternative methods to conventional enamel etching with phosphoric acid have been sought aiming at decreasing the bond strength to reduce the incidence of enamel damage. The use of glass ionomer cements for orthodontic bonding decreased the occurrence of enamel damage, yet at the expense of clinically unacceptable bond strengths. On the other hand, the use of laser etching and self- etch primers resulted in bracket shear bond strengths comparable to the conventional etch-and-rinse approach, but could not eliminate enamel damage. In 2019, Ibrahim et al developed a new bioactive orthodontic etchant paste made of calcium-phosphate (CaP), which could alleviate subsurface enamel demineralization in comparison with the traditional phosphoric acid etchant and the pre-clinical viability assessment using in vitro studies showed exemplary advantages. The new low-pH CaP paste etchant application is a clinically viable bracket bonding method with steps similar to PA application that yielded adequate bond strength with the advantages of minimal adhesive remnants and no enamel chipping or cracking on deboning of the bracket.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a multi-center, single-operator, split-mouth randomized controlled trial with a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Novel etchent paste | Experimental | Other: Enamel conditioning with a novel etchant paste |
| Phosphoric acid 37% | Active comparator | Other: Enamel conditioning with a novel etchant paste |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Full permanent dentition including incisors, canines, premolars, and first molars.
- Teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide.
- No previous orthodontic treatment with fixed appliances.
Key exclusion criteria (3 listed)
- Were unable to give informed consent) Had craniofacial anomalies.
- Required orthognathic surgery as part of their treatment.
- Had 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 |
|---|---|---|
| Enamel conditioning with a novel etchant pasteAlso: Etching for enamel for bracket bondingThe maxillary and mandibular incisors, canines, and premolars for each patient will be conditioned using the Novel etchent paste on one side (experimental), while the other side (control) conditioned with a phosphoric acid gel 37% . Both systems use identical brackets and adhesive system (differ only with regard to the etching system). | Other | Novel etchent paste, Phosphoric acid 37% |
Primary outcome
Bracket failure rate
Time frame: 6 months
Patients with repeated bond failures caused by habits or trauma would be excluded from further analysis.only counting the number of brackets that broken .
1 secondary outcome
Adhesive remenant index
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Background: PubMed 32382380Ibrahim AI, Al-Hasani NR, Thompson VP, Deb S. Resistance of bonded premolars to four artificial ageing models post enamel conditioning with a novel calcium-phosphate paste. J Clin Exp Dent. 2020 Apr 1;12(4):e317-e326. doi: 10.4317/jced.56764. eCollection 2020 Apr.
- Individual participant dataSharing planned: Undecided. till now there is no plan to share it when i found it i will updated it.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enamel conditioning with a novel etchant paste in people with Orthodontic Appliance Complication, run by University of Baghdad at 1 site in Iraq.
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 3 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: status not confirmed, as of the sponsor's last update on 21 Mar 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 Iraq. 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?
Results are not available in the source record.
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?
Bracket failure rate (time frame: 6 months). 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 NCT05766033, 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 21 Mar 2023.