MalocclusionNCT01925924
RMGI v Composite for Orthodontic Bonding
A study testing Resin-modified glass ionomer cement and Composite resin in people with Malocclusion, run by Sheffield Teaching Hospitals NHS Foundation Trust at 5 sites in 2 countries.
Trial summary
Demineralization during orthodontic (brace) treatment is a common clinical problem leading to unsightly white or brown marks on the teeth. A recent systematic review has shown little evidence that current methods of delivering fluoride are effective at reducing this problem. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Malocclusion
- What is being tested?
- Resin-modified glass ionomer cement and Composite resin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Feb 2009to 31 Dec 2017
- 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 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 11 years of age or older;
- In good general health;
- Brush his/her teeth at least once per day;
- Have canine and incisor teeth fully erupted and of normal form on either side of upper/lower arch;
- Require upper and/or lower pre-adjusted edgewise fixed appliance therapy;
- Have given written informed consent;
- Be willing and able to comply with the trial regime.
Who cannot join
- Undergoing orthognathic treatment;
- Patients with a cleft of the lip or palate;
- Patients with any heart condition or disease necessitating antibiotic cover;
- Diabetes mellitus; epilepsy; physical or mental handicap;
- Poor periodontal health, including the presence of supragingival calculus/subgingival calculus/periodontal pocketing greater than 3mm;
- Gross or uncontrolled caries;
Show all 9Show fewer
- Labial demineralisation on a canine or incisor tooth;
- Absent or peg-shaped lateral incisors;
- Palatal canines and /or ectopic unerupted incisors.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United Kingdom4 sites
Hightown Orthodontics
Crewe, Cheshire
Charles Clifford Dental Hospital
Sheffield, South Yorkshire, S10 2TA
The Orthodontic Centre
Sheffield, South Yorkshire, S10
Inline Orthodontics
Stevenage, Hertfordshire, SG1 1DU
About this study
Official title: Resin-modified Glass Ionomer or Composite for Orthodontic Bonding? - a Multi-centre, Randomised, Single Blinded Clinical Trial
Demineralization during orthodontic (brace) treatment is a common clinical problem leading to unsightly white or brown marks on the teeth. A recent systematic review has shown little evidence that current methods of delivering fluoride are effective at reducing this problem.
Design: A multi-centre randomised single blinded controlled clinical trial will be conducted with two parallel groups.
Read more
Setting: The trial patients will be treated by eight named operators on the Specialist List for Orthodontics held by the General Dental Council and who work either within the hospital service or specialist orthodontic practice. The sample size calculation suggests that each operator will need to treat 40 patients in the trial (approx 1 session per week) plus up to 10 familiarisation patients before.
Planned trial interventions: Brackets will be bonded to all teeth in front of the first permanent molars with either a resin-modified glass ionomer cement (Fuji Ortho LC) or a light cured composite control (Transbond). The material to be bonded will be allocated randomly.
Outcome measures: The two main outcome measures will be the difference in demineralization of the anterior teeth before and after treatment assessed from photographs and the number of debonded brackets during treatment.
Read the detailed description
Demineralization (dental decay) around fixed appliance components has been reported to occur in up to 95% of cases where brackets are bonded with composite resins. Although early lesions appear clinically as opaque white or brown areas, if mineral loss continues cavitation will occur. Following appliance removal, the lesions may regress or disappear but may still present an aesthetic problem more than 5 years after appliance removal. Fluoride is known to inhibit lesion development and to enhance remineralization following treatment. Resin-modified glass ionomer cements, which release and absorb fluoride, may be used for bracket bonding thereby offering the possibility of less demineralization around bonded attachments. In addition, these cements appear to behave as reliably as composite in terms of bracket failure rate recorded but these data are from case series rather than optimally designed randomised clinical trials. A bonding agent that can behave as reliably as composite and minimize unwanted enamel demineralization would be optimal; saving on restorative costs that may be required should cavitation occur. From the patients perspective, subjective assessment of treatment outcome is likely to be enhanced as ugly demineralised enamel white lesions will be eliminated.
- Conditions
- Malocclusion
- Being tested
- Resin-modified glass ionomer cement, Composite resin
- Keywords
- Dental cements, Orthodontic adhesives, Glass ionomer cement, Tooth demineralization
- Medical subject headings
- Malocclusion, Tooth Demineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin-modified glass ionomer cementOther
Also called Brand name: Fuji Ortho
This material contains fluoride
Composite resinOther
Also called Brand name: Transbond
This material does not include fluoride
| Study group | Role | What they receive |
|---|---|---|
| Resin-modified glass ionomer cement | Experimental | Resin-modified glass ionomer cement is used to attach the fixed orthodontic brackets (brace) to the teeth. Receives: Other: Resin-modified glass ionomer cement |
| Composite resin | Active comparator | Composite resin is used to attach fixed orthodontic brackets (brace)to the teeth. Receives: Other: Composite resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of demineralised white lesions on the teeth
Demineralisation will be assessed from standardised colour images of the upper and lower incisors and canines taken pre-treatment and immediately post-debond
Measured: Assessed the day the fixed orthodontic appliance is removed
Secondary outcomes (1)
The incidence of orthodontic bracket failure
All first time bond/band failures will be recorded at each treatment visit and dated in each subject's data collection form for subsequent failure rate assessment and survival analyses
Measured: Assessed the day the fixed orthodontic appliance is removed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startFeb 2009
- Primary completionDec 2013
- Study completion31 Dec 2017
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip E Benson, PhD, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925924
- Sponsor's protocol ID
- STH14372
- Status last verified
- Jan 2018
- First submitted
- 16 Aug 2013
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: May share if suitably anonymised
Publications
Benson PE, Alexander-Abt J, Cotter S, Dyer FMV, Fenesha F, Patel A, Campbell C, Crowley N, Millett DT. Resin-modified glass ionomer cement vs composite for orthodontic bonding: A multicenter, single-blind, randomized controlled trial. Am J Orthod Dentofacial Orthop. 2019 Jan;155(1):10-18. doi: 10.1016/j.ajodo.2018.09.005.
PubMed 30591153
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resin-modified Glass Ionomer or Composite for Orthodontic Bonding? - a Multi-centre, Randomised, Single Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT01925924
- Acronym / sponsor ID
- STH14372
- Conditions
- Malocclusion
- Keywords
- Dental cements, Orthodontic adhesives, Glass ionomer cement, Tooth demineralization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 20 Aug 2013 (estimated)
- 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.
Demineralization during orthodontic (brace) treatment is a common clinical problem leading to unsightly white or brown marks on the teeth. A recent systematic review has shown little evidence that current methods of delivering fluoride are effective at reducing this problem.
Design: A multi-centre randomised single blinded controlled clinical trial will be conducted with two parallel groups.
Setting: The trial patients will be treated by eight named operators on the Specialist List for Orthodontics held by the General Dental Council and who work either within the hospital service or specialist orthodontic practice. The sample size calculation suggests that each operator will need to treat 40 patients in the trial (approx 1 session per week) plus up to 10 familiarisation patients before.
Planned trial interventions: Brackets will be bonded to all teeth in front of the first permanent molars with either a resin-modified glass ionomer cement (Fuji Ortho LC) or a light cured composite control (Transbond). The material to be bonded will be allocated randomly.
Outcome measures: The two main outcome measures will be the difference in demineralization of the anterior teeth before and after treatment assessed from photographs and the number of debonded brackets during treatment.
Detailed description
Demineralization (dental decay) around fixed appliance components has been reported to occur in up to 95% of cases where brackets are bonded with composite resins. Although early lesions appear clinically as opaque white or brown areas, if mineral loss continues cavitation will occur. Following appliance removal, the lesions may regress or disappear but may still present an aesthetic problem more than 5 years after appliance removal. Fluoride is known to inhibit lesion development and to enhance remineralization following treatment. Resin-modified glass ionomer cements, which release and absorb fluoride, may be used for bracket bonding thereby offering the possibility of less demineralization around bonded attachments. In addition, these cements appear to behave as reliably as composite in terms of bracket failure rate recorded but these data are from case series rather than optimally designed randomised clinical trials. A bonding agent that can behave as reliably as composite and minimize unwanted enamel demineralization would be optimal; saving on restorative costs that may be required should cavitation occur. From the patients perspective, subjective assessment of treatment outcome is likely to be enhanced as ugly demineralised enamel white lesions will be eliminated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resin-modified glass ionomer cement | Experimental | Other: Resin-modified glass ionomer cementResin-modified glass ionomer cement is used to attach the fixed orthodontic brackets (brace) to the teeth. |
| Composite resin | Active comparator | Other: Composite resinComposite resin is used to attach fixed orthodontic brackets (brace)to the teeth. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 11 years of age or older;
- In good general health;
- Brush his/her teeth at least once per day;
- Have canine and incisor teeth fully erupted and of normal form on either side of upper/lower arch;
- Require upper and/or lower pre-adjusted edgewise fixed appliance therapy;
Key exclusion criteria (9 listed)
- Undergoing orthognathic treatment;
- Patients with a cleft of the lip or palate;
- Patients with any heart condition or disease necessitating antibiotic cover;
- Diabetes mellitus; epilepsy; physical or mental handicap;
- Poor periodontal health, including the presence of supragingival calculus/subgingival calculus/periodontal pocketing greater than 3mm;
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 |
|---|---|---|
| Resin-modified glass ionomer cementAlso: Brand name: Fuji OrthoThis material contains fluoride | Other | Resin-modified glass ionomer cement |
| Composite resinAlso: Brand name: TransbondThis material does not include fluoride | Other | Composite resin |
Primary outcome
Incidence and severity of demineralised white lesions on the teeth
Time frame: Assessed the day the fixed orthodontic appliance is removed
Demineralisation will be assessed from standardised colour images of the upper and lower incisors and canines taken pre-treatment and immediately post-debond
1 secondary outcome
The incidence of orthodontic bracket failure
Time frame: Assessed the day the fixed orthodontic appliance is removed
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 26 Jan 2018.
- Derived from this study: PubMed 30591153Benson PE, Alexander-Abt J, Cotter S, Dyer FMV, Fenesha F, Patel A, Campbell C, Crowley N, Millett DT. Resin-modified glass ionomer cement vs composite for orthodontic bonding: A multicenter, single-blind, randomized controlled trial. Am J Orthod Dentofacial Orthop. 2019 Jan;155(1):10-18. doi: 10.1016/j.ajodo.2018.09.005.
- Individual participant dataSharing planned: Undecided. May share if suitably anonymised
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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.
Philip E Benson, PhD principal investigator
University of Sheffield
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin-modified glass ionomer cement and Composite resin in people with Malocclusion, run by Sheffield Teaching Hospitals NHS Foundation Trust at 5 sites in 2 countries.
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 7 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 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, Ireland. 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?
Incidence and severity of demineralised white lesions on the teeth (time frame: Assessed the day the fixed orthodontic appliance is removed). 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 NCT01925924, 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 26 Jan 2018.