Enamel HypomineralizationNCT07814716
Clinical Performance of Orthodontic Bands in the Restorative Treatment of Hypomineralised Primary Second Molars
A study testing Orthodontic band restorative treatment and Hall Technique with preformed stainless steel crown in people with Enamel Hypomineralization, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
This randomised clinical trial will compare the clinical performance and acceptability of orthodontic bands and preformed stainless steel crowns for the restorative management of hypomineralised second primary molars. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Enamel Hypomineralization
- What is being tested?
- Orthodontic band restorative treatment and Hall Technique with preformed stainless steel crown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Nov 2025to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-10 years.
- Presence of at least one second primary molar affected by hypomineralised second primary molars requiring restorative treatment.
- Hypomineralisation associated with post-eruptive enamel breakdown involving more than one tooth surface or a cavitated carious lesion involving more than one surface and classified as code 5 or 6 according to the International Caries Detection and Assessment System.
Who cannot join
- Extensive carious lesion with subgingival margins.
- Clinical or radiographic signs of pulpal inflammation or necrosis.
- Advanced physiological root resorption indicating imminent exfoliation of the eligible tooth.
- Previous restorative treatment of the eligible tooth.
- Presence of bruxism.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Rio Grande do Norte
Natal, Rio Grande do Norte, 59056-000
Lavínia L. Costa, Master's, +55 84 998987405, lavinialourencocosta@gmail.com
About this study
Official title: Clinical Performance of Orthodontic Bands in the Restorative Treatment of Hypomineralised Primary Second Molars: a Randomised Clinical Trial
This randomised clinical trial will compare the clinical performance and acceptability of orthodontic bands and preformed stainless steel crowns for the restorative management of hypomineralised second primary molars. Thirty children aged 5-10 years will be randomly allocated in a 1:1 ratio to receive either an orthodontic band or a stainless steel crown. One index tooth per participant will be evaluated immediately after treatment and at 6, 12, and 18 months. The primary outcomes will be marginal adaptation, retention, and the presence of carious lesions. Secondary outcomes will include biofilm accumulation and treatment acceptability among children and their caregivers.
Read the detailed description
Hypomineralised second primary molars are more susceptible to post-eruptive enamel breakdown, carious lesions, hypersensitivity, and premature tooth loss. Although preformed stainless steel crowns have demonstrated favourable clinical performance in primary molars, orthodontic bands may represent a less invasive restorative approach for maintaining affected teeth until physiological exfoliation. However, their clinical performance in hypomineralised primary teeth has not been investigated.
This parallel-group randomised clinical trial will include 30 children presenting at least one hypomineralised second primary molar with extensive post-eruptive enamel breakdown or a cavitated carious lesion requiring restorative treatment. Participants will be randomly allocated to receive either an orthodontic band cemented with glass ionomer luting cement after restoration of the cavitated lesion or a preformed stainless steel crown placed using the Hall technique. When more than one tooth is eligible, one index tooth will be randomly selected for the primary analysis.
Clinical assessments will be performed immediately after treatment and at 6, 12, and 18 months. Marginal adaptation, retention, and carious lesions adjacent to the restoration margins will be assessed using modified United States Public Health Service criteria. Biofilm accumulation will be assessed using the Silness and Löe Plaque Index. Treatment acceptability will be evaluated immediately after treatment using separate questionnaires for children and caregivers. Physiological exfoliation during follow-up will be recorded separately and will not be considered treatment failure.
- Conditions
- Enamel Hypomineralization
- Being tested
- Orthodontic band restorative treatment, Hall Technique with preformed stainless steel crown
- Keywords
- orthodontic bands, stainless steel crowns, enamel defects, hspm
- Medical subject headings
- Dental Enamel Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic band restorative treatmentProcedure or surgery
Selective removal of softened carious dentine, when present, followed by restoration with conventional glass ionomer cement and placement of a prefabricated stainless steel orthodontic band cemented with glass ionomer luting cement.
Hall Technique with preformed stainless steel crownProcedure or surgery
Placement of a preformed stainless steel crown using the Hall technique, without caries removal, local anaesthesia, or tooth preparation. The crown will be cemented with glass ionomer luting cement.
| Study group | Role | What they receive |
|---|---|---|
| Bands | Experimental | Participants allocated to this arm will receive selective removal of softened carious dentine when carious tissue is present, followed by restoration of the cavity with conventional glass ionomer restorative cement (GC Gold Label 9). A prefabricated stainless steel orthodontic band will then be adapted to the index tooth and cemented with glass ionomer luting cement (Meron). Receives: Procedure: Orthodontic band restorative treatment |
| Crowns | Active comparator | articipants allocated to this arm will receive a preformed stainless steel crown placed using the Hall technique, without caries removal, local anaesthesia, or tooth preparation. When a large cavity is present, glass ionomer restorative cement (GC Gold Label 9) will be placed at its base without prior caries removal. The crown will be cemented with glass ionomer luting cement (Meron). Receives: Procedure: Hall Technique with preformed stainless steel crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal adaptation
Marginal adaptation will be assessed using modified United States Public Health Service criteria: Alpha, continuous margin without a detectable gap; Bravo, minor discontinuity not requiring clinical intervention; and Charlie, marginal defect requiring repair or replacement. Alpha and Bravo will be considered clinically satisfactory, whereas Charlie will be considered a failure.
Measured: 18 months after treatment
Retention
Retention will be classified as Alpha when the orthodontic band or stainless steel crown remains firmly cemented and functional, or Charlie when it is lost or dislodged and requires recementation or replacement. Alpha will be considered successful retention and Charlie a failure.
Measured: 18 months after treatment
Presence of carious lesions
Carious lesions adjacent to the restoration margins will be assessed clinically and classified as Alpha when absent or Charlie when present. Alpha will be considered clinically satisfactory and Charlie a failure.
Measured: 18 months after treatment
Secondary outcomes (3)
Biofilm accumulation
Biofilm accumulation will be assessed using the Silness and Löe Plaque Index, ranging from 0 to 3: 0, absence of biofilm; 1, thin biofilm film along the free gingival margin; 2, moderate accumulation within the gingival sulcus; and 3, abundant accumulation within the gingival sulcus. Lower scores indicate less biofilm accumulation.
Measured: Immediately after treatment and at 6, 12, and 18 months
Child-reported treatment acceptability
Acceptability will be assessed using a five-item questionnaire. Each item will be scored from 0 to 4, resulting in a total score ranging from 0 to 20. The negatively worded item will be reverse-scored. Higher total scores indicate greater treatment acceptability.
Measured: Immediately after treatment
Caregiver-reported treatment acceptability
Acceptability will be assessed using a five-item questionnaire. Each item will be scored from 0 to 4, resulting in a total score ranging from 0 to 20. Higher total scores indicate greater treatment acceptability.
Measured: Immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start3 Nov 2025
- Primary completionAug 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Enamel HypomineralizationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lavínia Lourenço Costa, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814716
- Sponsor's protocol ID
- 8.054.527
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Talekar AL, Waggoner WF, Silotry TMH, Musale PK, Chaudhari GS. Prospective, Randomized, Clinical Evaluation of Preformed Zirconia Crowns and Stainless Steel Crowns on Permanent First Molars: 12-Month Results. Pediatr Dent. 2023 May 15;45(3):232-239.
PubMed 37381120Bekes K, Steffen R, Kramer N. Hypomineralised second primary molars: the Wurzburg concept. Eur Arch Paediatr Dent. 2024 Aug;25(4):597-602. doi: 10.1007/s40368-024-00913-7. Epub 2024 May 28.
PubMed 38805129Bagattoni S, Gozzi I, Lunardon C, Gatto MR, Piana G, Lardani L. Orthodontic Bands for Preventing Post-Eruptive Breakdown in Molars Affected by Molar Incisor Hypomineralisation. Eur J Paediatr Dent. 2025 Sep 1;26(3):212-217. doi: 10.23804/ejpd.2025.2380. Epub 2025 Apr 1.
PubMed 40243404
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Orthodontic Bands in the Restorative Treatment of Hypomineralised Primary Second Molars: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT07814716
- Acronym / sponsor ID
- 8.054.527
- Conditions
- Enamel Hypomineralization
- Keywords
- orthodontic bands, stainless steel crowns, enamel defects, hspm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 11 Sep 2026 (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.
This randomised clinical trial will compare the clinical performance and acceptability of orthodontic bands and preformed stainless steel crowns for the restorative management of hypomineralised second primary molars. Thirty children aged 5-10 years will be randomly allocated in a 1:1 ratio to receive either an orthodontic band or a stainless steel crown. One index tooth per participant will be evaluated immediately after treatment and at 6, 12, and 18 months. The primary outcomes will be marginal adaptation, retention, and the presence of carious lesions. Secondary outcomes will include biofilm accumulation and treatment acceptability among children and their caregivers.
Detailed description
Hypomineralised second primary molars are more susceptible to post-eruptive enamel breakdown, carious lesions, hypersensitivity, and premature tooth loss. Although preformed stainless steel crowns have demonstrated favourable clinical performance in primary molars, orthodontic bands may represent a less invasive restorative approach for maintaining affected teeth until physiological exfoliation. However, their clinical performance in hypomineralised primary teeth has not been investigated.
This parallel-group randomised clinical trial will include 30 children presenting at least one hypomineralised second primary molar with extensive post-eruptive enamel breakdown or a cavitated carious lesion requiring restorative treatment. Participants will be randomly allocated to receive either an orthodontic band cemented with glass ionomer luting cement after restoration of the cavitated lesion or a preformed stainless steel crown placed using the Hall technique. When more than one tooth is eligible, one index tooth will be randomly selected for the primary analysis.
Clinical assessments will be performed immediately after treatment and at 6, 12, and 18 months. Marginal adaptation, retention, and carious lesions adjacent to the restoration margins will be assessed using modified United States Public Health Service criteria. Biofilm accumulation will be assessed using the Silness and Löe Plaque Index. Treatment acceptability will be evaluated immediately after treatment using separate questionnaires for children and caregivers. Physiological exfoliation during follow-up will be recorded separately and will not be considered treatment failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bands | Experimental | Procedure: Orthodontic band restorative treatmentParticipants allocated to this arm will receive selective removal of softened carious dentine when carious tissue is present, followed by restoration of the cavity with conventional glass ionomer restorative cement (GC Gold Label 9). A prefabricated stainless steel orthodontic band will then be adapted to the index tooth and cemented with glass ionomer luting cement (Meron). |
| Crowns | Active comparator | Procedure: Hall Technique with preformed stainless steel crownarticipants allocated to this arm will receive a preformed stainless steel crown placed using the Hall technique, without caries removal, local anaesthesia, or tooth preparation. When a large cavity is present, glass ionomer restorative cement (GC Gold Label 9) will be placed at its base without prior caries removal. The crown will be cemented with glass ionomer luting cement (Meron). |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 5-10 years.
- Presence of at least one second primary molar affected by hypomineralised second primary molars requiring restorative treatment.
- Hypomineralisation associated with post-eruptive enamel breakdown involving more than one tooth surface or a cavitated carious lesion involving more than one surface and classified as code 5 or 6 according to the International Caries Detection and Assessment System.
Key exclusion criteria (5 listed)
- Extensive carious lesion with subgingival margins.
- Clinical or radiographic signs of pulpal inflammation or necrosis.
- Advanced physiological root resorption indicating imminent exfoliation of the eligible tooth.
- Previous restorative treatment of the eligible tooth.
- Presence of bruxism.
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 |
|---|---|---|
| Orthodontic band restorative treatmentSelective removal of softened carious dentine, when present, followed by restoration with conventional glass ionomer cement and placement of a prefabricated stainless steel orthodontic band cemented with glass ionomer luting cement. | Procedure or surgery | Bands |
| Hall Technique with preformed stainless steel crownPlacement of a preformed stainless steel crown using the Hall technique, without caries removal, local anaesthesia, or tooth preparation. The crown will be cemented with glass ionomer luting cement. | Procedure or surgery | Crowns |
Primary outcome
Marginal adaptation
Time frame: 18 months after treatment
Marginal adaptation will be assessed using modified United States Public Health Service criteria: Alpha, continuous margin without a detectable gap; Bravo, minor discontinuity not requiring clinical intervention; and Charlie, marginal defect requiring repair or replacement. Alpha and Bravo will be considered clinically satisfactory, whereas Charlie will be considered a failure.
Retention
Time frame: 18 months after treatment
Retention will be classified as Alpha when the orthodontic band or stainless steel crown remains firmly cemented and functional, or Charlie when it is lost or dislodged and requires recementation or replacement. Alpha will be considered successful retention and Charlie a failure.
Presence of carious lesions
Time frame: 18 months after treatment
Carious lesions adjacent to the restoration margins will be assessed clinically and classified as Alpha when absent or Charlie when present. Alpha will be considered clinically satisfactory and Charlie a failure.
3 secondary outcomes
Biofilm accumulation
Time frame: Immediately after treatment and at 6, 12, and 18 months
Child-reported treatment acceptability
Time frame: Immediately after treatment
Caregiver-reported treatment acceptability
Time frame: Immediately after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 37381120Talekar AL, Waggoner WF, Silotry TMH, Musale PK, Chaudhari GS. Prospective, Randomized, Clinical Evaluation of Preformed Zirconia Crowns and Stainless Steel Crowns on Permanent First Molars: 12-Month Results. Pediatr Dent. 2023 May 15;45(3):232-239.
- Background: PubMed 38805129Bekes K, Steffen R, Kramer N. Hypomineralised second primary molars: the Wurzburg concept. Eur Arch Paediatr Dent. 2024 Aug;25(4):597-602. doi: 10.1007/s40368-024-00913-7. Epub 2024 May 28.
- Background: PubMed 40243404Bagattoni S, Gozzi I, Lunardon C, Gatto MR, Piana G, Lardani L. Orthodontic Bands for Preventing Post-Eruptive Breakdown in Molars Affected by Molar Incisor Hypomineralisation. Eur J Paediatr Dent. 2025 Sep 1;26(3):212-217. doi: 10.23804/ejpd.2025.2380. Epub 2025 Apr 1.
- Individual participant dataSharing planned: No
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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.
Federal University of Rio Grande do Norte
Natal, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic band restorative treatment and Hall Technique with preformed stainless steel crown in people with Enamel Hypomineralization, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
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 5 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal adaptation (time frame: 18 months after treatment). The study lists 3 primary outcomes in all. 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 NCT07814716, which also lists 3 linked publications.
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 15 Sep 2026.