Deep Caries Lesion of Primary TeethNCT02903979
Impact of Different Restorative Treatments for Deep Caries Lesion in Primary Teeth
A study testing HVGIC and Indirect pulp capping in people with Deep Caries Lesion of Primary Teeth, run by Universidade Ibirapuera at 1 site in Brazil.
Trial summary
In front of a lack of evidence to determine the best treatment for deep cavitated carious lesions, the search for an effective restorative technique, which results in a least possible discomfort to patients, and reduce the time needed for the restorative treatment, if becomes relevant. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Caries Lesion of Primary Teeth
- What is being tested?
- HVGIC and Indirect pulp capping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2016to May 2020
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children will be included that have at least one primary molar with deep cavitated carious lesions in occlusal 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 pulp exposure, spontaneous pain, mobility, presence of abscess or fistula next to the tooth, teeth with restorations, sealants or enamel formation defects will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
In front of a lack of evidence to determine the best treatment for deep cavitated carious lesions, the search for an effective restorative technique, which results in a least possible discomfort to patients, and reduce the time needed for the restorative treatment, if becomes relevant. The objective of this randomized clinical trial to evaluate the efficacy of high viscosity glass ionomer cement restorations (HVGIC) compared to restoration with calcium hydroxide restoration associated with high viscosity glass ionomer cement (HVGIC) for treatment of deep lesions in primary molars, as well as the impact of treatment in the criteria focused on the patient as well as cost-efficacy of the techniques . Children with 4 to 8 years will be selected randomly at the Clinic for Children at the University Ibirapuera of Dentistry. 108 teeth will be randomized into two groups: (1) restoration with calcium hydroxide cement associated with HVGIC and (2) HVGIC restoration. The restorations will be evaluated after 6, 12 and 24 months by two trained examiners blinded to the treatments. The efficacy of each treatment is measured by four main outcomes, which are: (1) criteria related to the effectiveness of the restorative treatment (2) criteria focused on the patient and (3) cost-efficacy. For comparison between the two groups will be used the Kaplan-Meier survival and the long-rank test. Cox regression is performed the assessment of the influence of some other variable results. For all analyzes, the significance level is set at 5%.
- Conditions
- Deep Caries Lesion of Primary Teeth
- Being tested
- HVGIC, Indirect pulp capping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVGICOther
In experimental group, the researches will be performed a restoration, after partial caries removal, with high viscosity glass ionomer cement in the teeth with deep caries lesion.
Indirect pulp cappingOther
In control group, the researches will be performed a indirect pulp capping with calcium hydroxide cement and high viscosity glass ionomer cement in the teeth with deep caries lesion.
| Study group | Role | What they receive |
|---|---|---|
| HVGIC | Experimental | Restorations with only HVGIC in deep caries lesion of primary teeth. Receives: Other: HVGIC |
| Indirect pulp capping | Active comparator | Indirect pulp capping with calcium hydroxide cement, restored with HVGIC: Receives: Other: Indirect pulp capping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulp Vitality
To evaluate the survival of different restorative treatments considering the pulp vitality.
Measured: Up to 24 months
Secondary outcomes (4)
Wong-Baker scale to discomfort
To evaluate the discomfort of different restorative treatments by a Wong-Baker scale.
Measured: Immediately to restoration procedure.
Cost-efficacy analysis by total value of treatment in relation to efficacy
To evaluate the cost-efficacy of different restorative treatments by total value in dollar of treatment in relation to efficacy. The researchers would like to analyze that a treatment of low cost show the similar efficacy of a high cost treatment.
Measured: Up to 24 months
Restoration longevity
To evaluate the restoration longevity by clinical examination.
Measured: Up to 24 months.
Caries progression
To evaluate the caries progression by radiography.
Measured: Up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2018
- Study completionMay 2020
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 Deep Caries Lesion of Primary TeethStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (actual)
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
- NCT02903979
- Sponsor's protocol ID
- UNIB1
- Status last verified
- Jun 2020
- First submitted
- 6 Sep 2016
- Last updated
- 11 Jun 2020
- Results posted
- No
Publications
da Silva GSQ, Raggio DP, Machado GFR, Mello-Moura ACV, Gimenez T, Floriano I, Tedesco TK. Impact of different restorative treatments for deep caries lesion in primary teeth (CEPECO 1) - study protocol for a noninferiority randomized clinical trial. BMC Oral Health. 2019 Jan 8;19(1):6. doi: 10.1186/s12903-018-0703-3.
PubMed 30621659
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Restorative Treatments for Deep Caries Lesion in Primary Teeth
- ClinicalTrials.gov ID
- NCT02903979
- Acronym / sponsor ID
- UNIB1
- Conditions
- Deep Caries Lesion of Primary Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Universidade IbirapueraUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 16 Sep 2016 (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.
In front of a lack of evidence to determine the best treatment for deep cavitated carious lesions, the search for an effective restorative technique, which results in a least possible discomfort to patients, and reduce the time needed for the restorative treatment, if becomes relevant. The objective of this randomized clinical trial to evaluate the efficacy of high viscosity glass ionomer cement restorations (HVGIC) compared to restoration with calcium hydroxide restoration associated with high viscosity glass ionomer cement (HVGIC) for treatment of deep lesions in primary molars, as well as the impact of treatment in the criteria focused on the patient as well as cost-efficacy of the techniques . Children with 4 to 8 years will be selected randomly at the Clinic for Children at the University Ibirapuera of Dentistry. 108 teeth will be randomized into two groups: (1) restoration with calcium hydroxide cement associated with HVGIC and (2) HVGIC restoration. The restorations will be evaluated after 6, 12 and 24 months by two trained examiners blinded to the treatments. The efficacy of each treatment is measured by four main outcomes, which are: (1) criteria related to the effectiveness of the restorative treatment (2) criteria focused on the patient and (3) cost-efficacy. For comparison between the two groups will be used the Kaplan-Meier survival and the long-rank test. Cox regression is performed the assessment of the influence of some other variable results. For all analyzes, the significance level is set at 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HVGIC | Experimental | Other: HVGICRestorations with only HVGIC in deep caries lesion of primary teeth. |
| Indirect pulp capping | Active comparator | Other: Indirect pulp cappingIndirect pulp capping with calcium hydroxide cement, restored with HVGIC: |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children will be included that have at least one primary molar with deep cavitated carious lesions in occlusal surface.
Key exclusion criteria (1 listed)
- Patients will be excluded with special needs, using orthodontics devices and / or systemic diseases which may affect the oral cavity. Also, teeth with pulp exposure, spontaneous pain, mobility, presence of abscess or fistula next to the tooth, teeth with restorations, sealants or enamel formation defects will also 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 |
|---|---|---|
| HVGICIn experimental group, the researches will be performed a restoration, after partial caries removal, with high viscosity glass ionomer cement in the teeth with deep caries lesion. | Other | HVGIC |
| Indirect pulp cappingIn control group, the researches will be performed a indirect pulp capping with calcium hydroxide cement and high viscosity glass ionomer cement in the teeth with deep caries lesion. | Other | Indirect pulp capping |
Primary outcome
Pulp Vitality
Time frame: Up to 24 months
To evaluate the survival of different restorative treatments considering the pulp vitality.
4 secondary outcomes
Wong-Baker scale to discomfort
Time frame: Immediately to restoration procedure.
Cost-efficacy analysis by total value of treatment in relation to efficacy
Time frame: Up to 24 months
Restoration longevity
Time frame: Up to 24 months.
Caries progression
Time frame: Up to 24 months.
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 11 Jun 2020.
- Derived from this study: PubMed 30621659da Silva GSQ, Raggio DP, Machado GFR, Mello-Moura ACV, Gimenez T, Floriano I, Tedesco TK. Impact of different restorative treatments for deep caries lesion in primary teeth (CEPECO 1) - study protocol for a noninferiority randomized clinical trial. BMC Oral Health. 2019 Jan 8;19(1):6. doi: 10.1186/s12903-018-0703-3.
Related trials for Deep Caries Lesion of Primary Teeth
Not yet recruiting
Caries Location and Its Effect on the Success Rate of Indirect Pulp Treatment in Primary Molars
Deep Caries Lesion of Primary Teeth, Dental Pulp Diseases
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 HVGIC and Indirect pulp capping in people with Deep Caries Lesion of Primary Teeth, 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 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: finished, as of the sponsor's last update on 11 Jun 2020. 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?
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?
Pulp Vitality (time frame: Up to 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 NCT02903979, 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 11 Jun 2020.