Dental Caries in ChildrenPhase 3NCT05875064
Aesthetic Restorations in Deciduous Anterior Teeth
A Phase 3 study testing Restoration with resin composite and polyvinyl crown and Restoration with conventional resin composite in people with Dental Caries in Children, run by University of Nove de Julho.
Trial summary
This study proposes to conduct a randomized clinical trial (RCT), composed of a sample of 194 deciduous central and lateral incisors with active cavitated lesions, simplified ICDAS C+ score, with involvement of more than two surfaces. Read more about this study
- Who is it for?
- Ages 12 to 60 months
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Restoration with resin composite and polyvinyl crown and Restoration with conventional resin composite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- No sites listed yet
- Study dates
- 26 Jan 2025to 30 Nov 2026
- Phase
- Phase 3
- 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 12 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ranging in age from 12 to 60 months with at least one active cavitated caries lesion involving more than 2 surfaces (C+ score) in deciduous upper incisors will be included.
Who cannot join
- Patients with special needs, with general health conditions that may affect the oral cavity, whose guardians do not sign the Inform Consent Form will be excluded. In addition, teeth with pulp exposure, spontaneous pain, mobility, presence of swelling or fistula near the tooth and teeth with previous restorations; less than 2/3 of root (radiographically assessed), teeth without an antagonist, teeth with previous restorations and children with bruxism and/or deep bite.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Aesthetic Restorations in Deciduous Anterior Teeth - Study Protocol for a Randomized Clinical Trial
This study proposes to conduct a randomized clinical trial (RCT), composed of a sample of 194 deciduous central and lateral incisors with active cavitated lesions, simplified ICDAS C+ score, with involvement of more than two surfaces. This sample will be divided into two experimental groups, both with selective removal of carious tissue: a group in which conventional restoration will be performed using opaque resins; and another group with monochromatic resin with chameleon effect and polyvinyl crowns.
- Conditions
- Dental Caries in Children
- Being tested
- Restoration with resin composite and polyvinyl crown, Restoration with conventional resin composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restoration with resin composite and polyvinyl crownCombination product
Restorative treatment of anterior primary teeth with monochromatic composite resin in single insertion through polyvinyl crowns, after selective removal of carious tissue compared to the effectiveness of conventional restoration.
Restoration with conventional resin compositeProcedure or surgery
Restorative treatment of anterior primary teeth with conventional composite resin, after selective removal of carious tissue
| Study group | Role | What they receive |
|---|---|---|
| conventional restoration group (control) | Active comparator | The teeth allocated in the conventional restoration group (control) will receive restorations in resin composed by incremental technique, using opaque resin. For this, 37% phosphoric acid (Condac37, FGM) will be applied for 15 seconds, and then, after washing and relative drying of the surface, application of universal adhesive (Universal Beautibond Adhesive, Shofu) with the aid of microbrush on the entire dental surface, photoactivation of the adhesive and restoration by incremental technique and photoactivation of each layer of resin for 20 seconds. The tooth will receive finishing and polishing through rotating instruments and abrasive discs (Supersnap, Shofu). Receives: Procedure: Restoration with conventional resin composite |
| polyvinyl crown - experimental group | Experimental | The teeth allocated in the experimental group will have the restorations carried out through monochromatic composite resin with chameleon effect in single insertion through polyvinyl crown. For this, 37% phosphoric acid (Condac37, FGM) will be applied for 15 seconds, and then, after washing and relative drying of the surface, application of universal adhesive (Universal Beautibond Adhesive, Shofu) with the aid of microbrush on the entire tooth surface, photoactivation of the adhesive and adaptation of the crown matrix in acetate filled with resin in the tooth. Photoactivation will be done for 20 seconds per dental face, and the acetate matrix is then removed. The tooth will receive finishing and polishing through rotating instruments and abrasive discs (Supersnap, Shofu). Receives: Combination Product: Restoration with resin composite and polyvinyl crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in progression of caries lesion through clinical criteria and longevity of restorations
The integrity of the restoration, its adaptation in all dental faces and identified possible failures related to structural fracture, resin wear, maladaptation or functional maintenance of the restored tooth will be verified.
The clinical evaluation of the retention of the restorations will be performed after 6, 12, 18 and 24 months, using the criteria: total retention; Partial retention 1 - presence of the resin in two thirds of the surface of each dental face; Partial retention 2 - presence of the resin in one third d and each face of the dental surface, total loss of resin on the surface of the dental surface.
It will also be evaluated the degree of tooth mobility and its relationship with the usual exfoliation period in the teeth belonging to both groups. In teeth where the restoration is intact and clinical features of associated lesions are not verified, the lesions will be considered as inactive.
Measured: Baseline and after 6, 12, 18 and 24 months.
Secondary outcomes (4)
Change in the progression of caries lesion by radiographic criteria
For the evaluation of caries progression, the modified periapical radiographic examination for preschoolers will be used. The images will be compared two by two in order to evaluate whether or not there was progression of caries:
- Absent progression: when there is no increase in the radiolucent area of the lesion.
- Progression present: when there is an increase in the radiolucent area of the lesion.
Teeth that present progression of caries lesion to signs of pulp involvement, will receive restorative or endodontic treatment compatible with the observed picture.
Measured: Baseline and after 6, 12, 18 and 24 months.
Change in the perception of parents/guardians
To evaluate the perception of parents/guardians in relation to the treatment performed, the questionnaire "Child's and parent's questionnaire about teeth appearance" will be used soon after the first treatment session and 6 months after the treatment. The examiners will guide you to express your real opinion.
Measured: Baseline and after 6, 12, 18 and 24 months.
Change in the satisfaction of parents/guardians
The parents/guardians will be asked about their satisfaction with the treatment performed on the child. They will answer 5 "yes" or "no" questions about how much they liked the procedures. The examiners will guide you to issue your real opinion after 6 months of treatment.
Measured: Baseline and after 6, 12, 18 and 24 months.
Change in the impact of treatments on children's oral health-related quality of life
A questionnaire will be applied to assess the impact of treatments on children's oral health-related quality of life. The validated Brazilian version of the Early Childhood Oral Health Impact Scale (ECOHIS) should be answered by the parents or guardians of the participants in the initial consultations and at each return. The higher the score, the worse is the children's oral health-related quality of life.
Measured: Baseline and after 6, 12, 18 and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start26 Jan 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (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 Dental Caries in ChildrenStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-inferiority randomized clinical trial with parallel arms, with an allocation ratio of 1:1
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875064
- Sponsor's protocol ID
- RehabAnteriorUnimes
- Status last verified
- Sep 2024
- First submitted
- 4 May 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data generated from this clinical trial will be made available to other researchers upon reasonable request. The data will be shared in accordance with BMJ's Tier 2 data policy, ensuring legal and ethical considerations are upheld. * Description of Data: The dataset includes anonymized patient records, clinical outcome measures, and intervention details. * Availability: Data will be accessible within 6 months of publication of the final study results. * Access: Requests for data access can be submitted through OSF. * Protection: Personal identifiers will be removed to protect participant confidentiality and comply with data protection regulations.
Publications
Gimenez T, Sobral APT, Santos EM, Goncalves MLL, Ferri EP, Gallo JMAS, Horliana ACRT, Motta LJ, Imparato JCP, Bussadori SK. An investigator-blinded, 24-month, parallel-group, non-inferiority study to compare aesthetic restorations in primary anterior teeth in a paediatric dental clinic: study protocol for a randomised controlled trial. BMJ Open. 2025 Feb 6;15(2):e086200. doi: 10.1136/bmjopen-2024-086200.
PubMed 39915031
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic Restorations in Deciduous Anterior Teeth - Study Protocol for a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05875064
- Acronym / sponsor ID
- RehabAnteriorUnimes
- Conditions
- Dental Caries in Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 26 Jan 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 25 May 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.
This study proposes to conduct a randomized clinical trial (RCT), composed of a sample of 194 deciduous central and lateral incisors with active cavitated lesions, simplified ICDAS C+ score, with involvement of more than two surfaces. This sample will be divided into two experimental groups, both with selective removal of carious tissue: a group in which conventional restoration will be performed using opaque resins; and another group with monochromatic resin with chameleon effect and polyvinyl crowns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a non-inferiority randomized clinical trial with parallel arms, with an allocation ratio of 1:1
| Arm | Type | Receives |
|---|---|---|
| conventional restoration group (control) | Active comparator | Procedure: Restoration with conventional resin compositeThe teeth allocated in the conventional restoration group (control) will receive restorations in resin composed by incremental technique, using opaque resin. For this, 37% phosphoric acid (Condac37, FGM) will be applied for 15 seconds, and then, after washing and relative drying of the surface, application of universal adhesive (Universal Beautibond Adhesive, Shofu) with the aid of microbrush on the entire dental surface, photoactivation of the adhesive and restoration by incremental technique and photoactivation of each layer of resin for 20 seconds. The tooth will receive finishing and polishing through rotating instruments and abrasive discs (Supersnap, Shofu). |
| polyvinyl crown - experimental group | Experimental | Combination Product: Restoration with resin composite and polyvinyl crownThe teeth allocated in the experimental group will have the restorations carried out through monochromatic composite resin with chameleon effect in single insertion through polyvinyl crown. For this, 37% phosphoric acid (Condac37, FGM) will be applied for 15 seconds, and then, after washing and relative drying of the surface, application of universal adhesive (Universal Beautibond Adhesive, Shofu) with the aid of microbrush on the entire tooth surface, photoactivation of the adhesive and adaptation of the crown matrix in acetate filled with resin in the tooth. Photoactivation will be done for 20 seconds per dental face, and the acetate matrix is then removed. The tooth will receive finishing and polishing through rotating instruments and abrasive discs (Supersnap, Shofu). |
Who may qualify
- Ages
- 12 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children ranging in age from 12 to 60 months with at least one active cavitated caries lesion involving more than 2 surfaces (C+ score) in deciduous upper incisors will be included.
Key exclusion criteria (1 listed)
- Patients with special needs, with general health conditions that may affect the oral cavity, whose guardians do not sign the Inform Consent Form will be excluded. In addition, teeth with pulp exposure, spontaneous pain, mobility, presence of swelling or fistula near the tooth and teeth with previous restorations; less than 2/3 of root (radiographically assessed), teeth without an antagonist, teeth with previous restorations and children with bruxism and/or deep bite.
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 |
|---|---|---|
| Restoration with resin composite and polyvinyl crownRestorative treatment of anterior primary teeth with monochromatic composite resin in single insertion through polyvinyl crowns, after selective removal of carious tissue compared to the effectiveness of conventional restoration. | Combination product | polyvinyl crown - experimental group |
| Restoration with conventional resin compositeRestorative treatment of anterior primary teeth with conventional composite resin, after selective removal of carious tissue | Procedure or surgery | conventional restoration group (control) |
Primary outcome
Change in progression of caries lesion through clinical criteria and longevity of restorations
Time frame: Baseline and after 6, 12, 18 and 24 months.
The integrity of the restoration, its adaptation in all dental faces and identified possible failures related to structural fracture, resin wear, maladaptation or functional maintenance of the restored tooth will be verified. The clinical evaluation of the retention of the restorations will be performed after 6, 12, 18 and 24 months, using the criteria: total retention; Partial retention 1 - presence of the resin in two thirds of the surface of each dental face; Partial retention 2 - presence of the resin in one third d and each face of the dental surface, total loss of resin on the surface of the dental surface. It will also be evaluated the degree of tooth mobility and its relationship with the usual exfoliation period in the teeth belonging to both groups. In teeth where the restoration is intact and clinical features of associated lesions are not verified, the lesions will be considered as inactive.
4 secondary outcomes
Change in the progression of caries lesion by radiographic criteria
Time frame: Baseline and after 6, 12, 18 and 24 months.
Change in the perception of parents/guardians
Time frame: Baseline and after 6, 12, 18 and 24 months.
Change in the satisfaction of parents/guardians
Time frame: Baseline and after 6, 12, 18 and 24 months.
Change in the impact of treatments on children's oral health-related quality of life
Time frame: Baseline and after 6, 12, 18 and 24 months.
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 22 Nov 2024.
- Derived from this study: PubMed 39915031Gimenez T, Sobral APT, Santos EM, Goncalves MLL, Ferri EP, Gallo JMAS, Horliana ACRT, Motta LJ, Imparato JCP, Bussadori SK. An investigator-blinded, 24-month, parallel-group, non-inferiority study to compare aesthetic restorations in primary anterior teeth in a paediatric dental clinic: study protocol for a randomised controlled trial. BMJ Open. 2025 Feb 6;15(2):e086200. doi: 10.1136/bmjopen-2024-086200.
- Individual participant dataSharing planned: Yes. Data generated from this clinical trial will be made available to other researchers upon reasonable request. The data will be shared in accordance with BMJ's Tier 2 data policy, ensuring legal and ethical considerations are upheld. * Description of Data: The dataset includes anonymized patient records, clinical outcome measures, and intervention details. * Availability: Data will be accessible within 6 months of publication of the final study results. * Access: Requests for data access can be submitted through OSF. * Protection: Personal identifiers will be removed to protect participant confidentiality and comply with data protection regulations.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Restoration with resin composite and polyvinyl crown and Restoration with conventional resin composite in people with Dental Caries in Children, run by University of Nove de Julho.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Thais Gimenez (+5511989456585, thais.gimenez@alumni.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in progression of caries lesion through clinical criteria and longevity of restorations (time frame: Baseline and after 6, 12, 18 and 24 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 NCT05875064, 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 22 Nov 2024.