Dental CariesCEPECO2NCT03785730
Non-restorative Cavity Control in Anterior Cavitated Caries Lesion of Primary Teeth
A study testing Restoration with resin composite - RCR group in people with Dental Caries, run by Universidade Ibirapuera at 1 site in Brazil.
Trial summary
Background: Studies have questioned the necessity of restoring cavitated carious lesion on primary teeth, once the control of biofilm is the most important factor to arrest these lesions. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Restoration with resin composite - RCR group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Apr 2019to 30 Dec 2027
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children will be included that have at least one anterior tooth with carious lesion cavitated affecting the proximal surface.
Who cannot join
- Patients will be excluded with special needs, using orthodontics devices and/or systemic diseases which may affect the oral cavity.
- Also, teeth with lesions affecting more than one third of the buccal/lingual surfaces, with previous history of dental trauma, presenting pulp exposure, spontaneous pain, pathological mobility, presence of abscess or fistula next to the tooth, teeth with restorations, developmental enamel defects or physiological mobility (exfoliation) will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Non-restorative Cavity Control on Proximal Carious Lesions of Anterior Primary Teeth on the Tooth Survival and Patient-centered Outcomes (CEPECO 2) - Study Protocol for a Non-inferiority Randomized Clinical Trial
Background: Studies have questioned the necessity of restoring cavitated carious lesion on primary teeth, once the control of biofilm is the most important factor to arrest these lesions. This randomized clinical trial aimed to compare the survival of teeth treated with a non-restorative cavity control (NRCC) compared to resin composite restorations (RCR) on proximal carious lesion in anterior primary teeth, as well as the impact of these treatments on patient-centered outcomes. Methods: A randomized clinical trial with two parallels arms (1:1) will be conducted. Children between 3 and 6 years old will be selected from the Center of Clinic Research of Pediatric Dentistry of Ibirapuera University (UNIB), a dental trailer (FOUSP) located on Educational Complex Professor Carlos Osmarinho de Lima, the Pediatric Dentistry Clinic of Santa Cecília University and from the Pediatric Dentistry Clinic of University Center UNINOVAFAPI. One hundred and forty-eight teeth will be randomly distributed in two experimental groups: (1) Selective removal of carious tissue and RCR; or (2) NRCC through cavity enlargement using metallic sandpaper. The primary outcome will be tooth survival after 6, 12, 18, and 24 months. The duration and the cost of dental treatments will be considered for the estimation of the cost-effectiveness of the evaluated treatments. The discomfort reported by the participants will be measured after each treatment using the FIS scale. The participants' satisfaction and perception of the parents/legal guardians will be evaluated through questionnaires. For the primary outcome, Kaplan-Meier's survival and Long-Rank test will be used for comparison between the two groups. All the variables will be modeled by Cox regression with shared fragility. Significance will be considered at 5%.
Read the detailed description
This non-inferiority randomized controlled clinical trial, with two parallel groups with 1:1 allocation ratio, was approved by the Research Ethics Committee of Universidade Ibirapuera (UNIB). The other centers involved are considered co-participants (Centro Universitário do Norte - Uninorte , Centro Universitário Uninovafapi - UNINOVAFAPI, and School of Dentistry from the University of Sao Paulo - FOUSP). Children aged 3 to 6 years with at least one proximal cavitated lesion on anterior primary teeth will be selected from the Clinical Pediatric Research Center. Teeth will be randomly allocated to selective removal of carious tissue and resin composite restoration (RCR) or NRCC. Tooth survival after two years of follow-up will be the primary outcome and cost-effectiveness, satisfaction, and discomfort reported by participants and parents/guardians' perception will be the secondary outcomes. Only patients who fulfill the eligibility criteria will be included in the study after the legal guardians sign the informed consent form and the child consents to participate in the study.
- Conditions
- Dental Caries
- Being tested
- Non-restorative cavity control - NRCC group, Restoration with resin composite - RCR group
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-restorative cavity control - NRCC groupProcedure or surgery
The proximal cavities will be enlarged with metallic sandpaper, exposing the cavity, to allow access for toothbrushing associated with 1000 ppm fluoride toothpaste.
Restoration with resin composite - RCR groupProcedure or surgery
In control group, the treatment will be performed after prophylaxis and relative isolation. The selective carious tissue removal will be performed with appropriate dentin curettes. The acid conditioning will be performed only in enamel for 15 s with 37% phosphoric acid gel, and then the application of the adhesive system and restoration of resin composite will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| Non-restorative cavity control - NRCC | Experimental | Enlargement with metallic sandpaper associated with toothbrushing/1000 ppm fluoride toothpaste. Receives: Procedure: Non-restorative cavity control - NRCC group |
| Resin composite restoration - RCR | Active comparator | Selective carious lesion removal and restoration with resin composite. Receives: Procedure: Restoration with resin composite - RCR group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth survival by clinical assessment
Comparing the survival of teeth treated with restoration of resin composite and with NRCC for lesions cavitated in anterior primary teeth by clinical assessment, considering as success when the teeth will be without clinical signs or symptoms of pulp pathology or exfoliated, with no need for more invasive interventions, such as pulpectomy or extraction.
Measured: 24 months
Secondary outcomes (4)
Discomfort regarding the treatment options by a Face image scale (FIS)
Children-reported discomfort regarding the treatment options by a Face image scale (FIS). The scale present 5 different faces since "very happy" (scored as 1) until "very sad" (scored as 5) with the treatment. Higher scores mean a worse discomfort.
Measured: Immediately after treatment
Cost-effectiveness analysis
The duration of the treatments (time of treatment) and the cost of the materials used will be considered for the estimation of the cost-efficacy of the treatments by a ratio - cost/effectiveness, being effectiveness considered the tooth survival.
Measured: 24 months.
Perception of parents / guardians evaluated through questionnaire
Parents perception of the treatments will be evaluated through a questionnaire - "Child's and parent's questionnaire about teeth appearance" - with possible answers varying from very satisfied until insatisfied. After the questionnaire is applied for the parents/guardians, the anwsers will bem transformed in scores 1 to 5, in according the original paper that validated the questionnaire. Higher scores mean a worse perception.
Measured: Prior to treatment, immediately after and 6 months later.
Satisfaction of children: questionnaire
Children-reported satisfaction regarding the treatment by a questionnaire with five question which for answers will be used a Face image scale (FIS). The scale present 5 different faces since "very happy" (scored as 1) until "very sad" (scored as 5) with the treatment. Lower scores mean a better satisfaction.
Measured: After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start30 Apr 2019
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2027 (estimated)
Why it stopped: Outbreak of COVID-19.
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 CariesStudies 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
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Ibirapuera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara Kerber Tedesco, Universidade Ibirapuera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785730
- Sponsor's protocol ID
- Unib3
- Acronym
- CEPECO2
- Status last verified
- May 2024
- First submitted
- 18 Dec 2018
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available on Mendeley database.
Publications
Bianchi RMD, Pascareli-Carlos AM, Floriano I, Raggio DP, Braga MM, Gimenez T, Holanda MC, da Silva GS, de Natal KH, Tedesco TK. Impact of non-restorative cavity control on proximal carious lesions of anterior primary teeth on the tooth survival and patient-centered outcomes (CEPECO 2): study protocol for a non-inferiority randomized clinical trial. BMC Oral Health. 2021 Mar 31;21(1):167. doi: 10.1186/s12903-021-01524-0.
PubMed 33789643
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-restorative Cavity Control on Proximal Carious Lesions of Anterior Primary Teeth on the Tooth Survival and Patient-centered Outcomes (CEPECO 2) - Study Protocol for a Non-inferiority Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03785730
- Acronym / sponsor ID
- CEPECO2 / Unib3
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Outbreak of COVID-19.
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Universidade IbirapueraUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 24 Dec 2018 (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.
Background: Studies have questioned the necessity of restoring cavitated carious lesion on primary teeth, once the control of biofilm is the most important factor to arrest these lesions. This randomized clinical trial aimed to compare the survival of teeth treated with a non-restorative cavity control (NRCC) compared to resin composite restorations (RCR) on proximal carious lesion in anterior primary teeth, as well as the impact of these treatments on patient-centered outcomes. Methods: A randomized clinical trial with two parallels arms (1:1) will be conducted. Children between 3 and 6 years old will be selected from the Center of Clinic Research of Pediatric Dentistry of Ibirapuera University (UNIB), a dental trailer (FOUSP) located on Educational Complex Professor Carlos Osmarinho de Lima, the Pediatric Dentistry Clinic of Santa Cecília University and from the Pediatric Dentistry Clinic of University Center UNINOVAFAPI. One hundred and forty-eight teeth will be randomly distributed in two experimental groups: (1) Selective removal of carious tissue and RCR; or (2) NRCC through cavity enlargement using metallic sandpaper. The primary outcome will be tooth survival after 6, 12, 18, and 24 months. The duration and the cost of dental treatments will be considered for the estimation of the cost-effectiveness of the evaluated treatments. The discomfort reported by the participants will be measured after each treatment using the FIS scale. The participants' satisfaction and perception of the parents/legal guardians will be evaluated through questionnaires. For the primary outcome, Kaplan-Meier's survival and Long-Rank test will be used for comparison between the two groups. All the variables will be modeled by Cox regression with shared fragility. Significance will be considered at 5%.
Detailed description
This non-inferiority randomized controlled clinical trial, with two parallel groups with 1:1 allocation ratio, was approved by the Research Ethics Committee of Universidade Ibirapuera (UNIB). The other centers involved are considered co-participants (Centro Universitário do Norte - Uninorte , Centro Universitário Uninovafapi - UNINOVAFAPI, and School of Dentistry from the University of Sao Paulo - FOUSP). Children aged 3 to 6 years with at least one proximal cavitated lesion on anterior primary teeth will be selected from the Clinical Pediatric Research Center. Teeth will be randomly allocated to selective removal of carious tissue and resin composite restoration (RCR) or NRCC. Tooth survival after two years of follow-up will be the primary outcome and cost-effectiveness, satisfaction, and discomfort reported by participants and parents/guardians' perception will be the secondary outcomes. Only patients who fulfill the eligibility criteria will be included in the study after the legal guardians sign the informed consent form and the child consents to participate in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-restorative cavity control - NRCC | Experimental | Procedure: Non-restorative cavity control - NRCC groupEnlargement with metallic sandpaper associated with toothbrushing/1000 ppm fluoride toothpaste. |
| Resin composite restoration - RCR | Active comparator | Procedure: Restoration with resin composite - RCR groupSelective carious lesion removal and restoration with resin composite. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children will be included that have at least one anterior tooth with carious lesion cavitated affecting the proximal surface.
Key exclusion criteria (2 listed)
- Patients will be excluded with special needs, using orthodontics devices and/or systemic diseases which may affect the oral cavity.
- Also, teeth with lesions affecting more than one third of the buccal/lingual surfaces, with previous history of dental trauma, presenting pulp exposure, spontaneous pain, pathological mobility, presence of abscess or fistula next to the tooth, teeth with restorations, developmental enamel defects or physiological mobility (exfoliation) will be excluded.
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 |
|---|---|---|
| Non-restorative cavity control - NRCC groupThe proximal cavities will be enlarged with metallic sandpaper, exposing the cavity, to allow access for toothbrushing associated with 1000 ppm fluoride toothpaste. | Procedure or surgery | Non-restorative cavity control - NRCC |
| Restoration with resin composite - RCR groupIn control group, the treatment will be performed after prophylaxis and relative isolation. The selective carious tissue removal will be performed with appropriate dentin curettes. The acid conditioning will be performed only in enamel for 15 s with 37% phosphoric acid gel, and then the application of the adhesive system and restoration of resin composite will be conducted. | Procedure or surgery | Resin composite restoration - RCR |
Primary outcome
Tooth survival by clinical assessment
Time frame: 24 months
Comparing the survival of teeth treated with restoration of resin composite and with NRCC for lesions cavitated in anterior primary teeth by clinical assessment, considering as success when the teeth will be without clinical signs or symptoms of pulp pathology or exfoliated, with no need for more invasive interventions, such as pulpectomy or extraction.
4 secondary outcomes
Discomfort regarding the treatment options by a Face image scale (FIS)
Time frame: Immediately after treatment
Cost-effectiveness analysis
Time frame: 24 months.
Perception of parents / guardians evaluated through questionnaire
Time frame: Prior to treatment, immediately after and 6 months later.
Satisfaction of children: questionnaire
Time frame: After 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Derived from this study: PubMed 33789643Bianchi RMD, Pascareli-Carlos AM, Floriano I, Raggio DP, Braga MM, Gimenez T, Holanda MC, da Silva GS, de Natal KH, Tedesco TK. Impact of non-restorative cavity control on proximal carious lesions of anterior primary teeth on the tooth survival and patient-centered outcomes (CEPECO 2): study protocol for a non-inferiority randomized clinical trial. BMC Oral Health. 2021 Mar 31;21(1):167. doi: 10.1186/s12903-021-01524-0.
- Individual participant dataSharing planned: Yes. Individual participant data will be available on Mendeley database.
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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 Restoration with resin composite - RCR group in people with Dental Caries, run by Universidade Ibirapuera 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 1 inclusion and 2 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: paused, as of the sponsor's last update on 10 May 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 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?
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?
Tooth survival by clinical assessment (time frame: 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 NCT03785730, 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 10 May 2024.