Caries, DentalNCT02494193
Indirect Pulp Capping With Resin Modified Glass Ionomer
A study testing Partial caries removal, Provisional restoration - experimental and Total caries removal in people with Caries, Dental and Pulpitis, run by Universidade Federal de Sergipe at 1 site in Brazil.
Trial summary
In deep carious lesions, presenting risk of pulp exposition, a treatment option is the partial caries removal of carious tissue followed by provisional restoration, while this approach is called indirect pulp capping. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Dental, Pulpitis
- What is being tested?
- Partial caries removal, Provisional restoration - experimental and Total caries removal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Dec 2016
- 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Molars and pre-molars presenting carious lesions involving 2/3 inner of dentin tissue.
Who cannot join
- Teeth presenting signs of irreversible pulpits or necrose, cervical lesion and/or root exposition, or with carious lesion reaching the pulp.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Indirect Pulp Capping With Resin Modified Glass Ionomer: a Randomized Controled Clinical Trial
In deep carious lesions, presenting risk of pulp exposition, a treatment option is the partial caries removal of carious tissue followed by provisional restoration, while this approach is called indirect pulp capping. The aim of this double-blinding controlled randomized clinical trial is to evaluate the success of indirect pulp capping using only resin-modified glass ionomer, while the additional layer of calcium hydroxide was used as control. The sample of 112 molars and/or premolars (n=56), presenting deep carious lesions, from patients with age between 15 and 30 years treated in dental clinic at Department of Dentistry of Federal University of Sergipe. The selected carious lesions must be reached 2/3 of dentin, observed in bite-wing radiography, without pulp involving and/or other factor that to compromise the evaluation. After detailed anamneses, the selected teeth will be radiographed e all carious tissue from surrounding walls will be removed. At the floor of cavity, the carious tissue will be partially removed using hand dentin excavators, remaining the caries-affected dentin and avoiding the pulp exposition. The removed carious tissue from the floor of cavity will be evaluated for presence of Lactobacilos e Estreptococos Mutans, while the remaining dentin will be evaluated for consistency, colour and humidity. Randomly, the cavity will be provisionally restored with: Control - dress and cement of calcium hydroxide followed resin-modified glass ionomer; or Experimental - only resin-modified glass ionomer. The distance between the base of restoration and the pulp cavity cap will be measured by bitw-wing radiography. The patients will be re-evaluated after 15 days, while the teeth with compromised pulp vitality will be excluded from the study. The remaining patients will be evaluated after 6 months. The distance between the base of restoration and the pulp cavity cap will be measured again, followed by provisional restoration removal. The remaining caries-affected dentin from floor of cavity will be fully removed and a bacteriological evaluation performed. The consistency, colour and humidity of this tissue will be evaluated too. Finally, the permanent restorations will performed.
- Conditions
- Caries, Dental, Pulpitis
- Being tested
- Partial caries removal, Provisional restoration - control, Provisional restoration - experimental, Total caries removal, Definitive restoration
- Medical subject headings
- Dental Caries, Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial caries removalOther
The caries infected dentin will be removed mantaining the affected caries tissue.
Provisional restoration - controlOther
After partial caries removal, a provisional restoration will be performed using a layer of calcium hydroxide paste covered by a layer of calcium hydroxide cement and resin-modified glass ionomer.
Provisional restoration - experimentalOther
After partial caries removal, a provisional restoration will be performed using only resin-modified glass ionomer.
Total caries removalOther
After two months of their placement, the provisional restoration will removed followed by tota caries tissue removal.
Definitive restorationOther
Definite restoration will be performed using composite.
| Study group | Role | What they receive |
|---|---|---|
| Regular Treatment | Active comparator | Partial caries removal; Provisional restoration - control; Total caries removal; Definitive restoration. Receives: Other: Partial caries removal; Other: Provisional restoration - control; Other: Total caries removal; Other: Definitive restoration |
| Alternative Treatment | Experimental | Partial caries removal; Provisional restoration - experimental; Total caries removal; Definitive restoration. Receives: Other: Partial caries removal; Other: Provisional restoration - experimental; Other: Total caries removal; Other: Definitive restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth vitality - analysis for positive or negative response
Measured: 2 months after placement of provisional restoration
Secondary outcomes (4)
Consistency of dentin tissue - scores of 1 (softned) to 4 (hard)
Measured: Immediately after caries removal
Coloration of dentin tissue - scores of 1 (clear yellow) to 5 (darkd)
Measured: Immediately after caries removal
Counting of Streptococcus mutans colonies - number of colony-forming units (CFUs)
Measured: Immediately after caries removal
Counting of Lactobacillus spp colonies - number of colony-forming units (CFUs)
Measured: Immediately after caries removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries, DentalStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sergipe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Luis Faria e Silva, Universidade Federal de Sergipe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494193
- Sponsor's protocol ID
- IPC
- Status last verified
- May 2017
- First submitted
- 30 Jun 2015
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Pulp Capping With Resin Modified Glass Ionomer: a Randomized Controled Clinical Trial
- ClinicalTrials.gov ID
- NCT02494193
- Acronym / sponsor ID
- IPC
- Conditions
- Caries, Dental, Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Universidade Federal de SergipeUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Jul 2015 (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 deep carious lesions, presenting risk of pulp exposition, a treatment option is the partial caries removal of carious tissue followed by provisional restoration, while this approach is called indirect pulp capping. The aim of this double-blinding controlled randomized clinical trial is to evaluate the success of indirect pulp capping using only resin-modified glass ionomer, while the additional layer of calcium hydroxide was used as control. The sample of 112 molars and/or premolars (n=56), presenting deep carious lesions, from patients with age between 15 and 30 years treated in dental clinic at Department of Dentistry of Federal University of Sergipe. The selected carious lesions must be reached 2/3 of dentin, observed in bite-wing radiography, without pulp involving and/or other factor that to compromise the evaluation. After detailed anamneses, the selected teeth will be radiographed e all carious tissue from surrounding walls will be removed. At the floor of cavity, the carious tissue will be partially removed using hand dentin excavators, remaining the caries-affected dentin and avoiding the pulp exposition. The removed carious tissue from the floor of cavity will be evaluated for presence of Lactobacilos e Estreptococos Mutans, while the remaining dentin will be evaluated for consistency, colour and humidity. Randomly, the cavity will be provisionally restored with: Control - dress and cement of calcium hydroxide followed resin-modified glass ionomer; or Experimental - only resin-modified glass ionomer. The distance between the base of restoration and the pulp cavity cap will be measured by bitw-wing radiography. The patients will be re-evaluated after 15 days, while the teeth with compromised pulp vitality will be excluded from the study. The remaining patients will be evaluated after 6 months. The distance between the base of restoration and the pulp cavity cap will be measured again, followed by provisional restoration removal. The remaining caries-affected dentin from floor of cavity will be fully removed and a bacteriological evaluation performed. The consistency, colour and humidity of this tissue will be evaluated too. Finally, the permanent restorations will performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Treatment | Active comparator | Other: Partial caries removal, Other: Provisional restoration - control, Other: Total caries removal, Other: Definitive restorationPartial caries removal; Provisional restoration - control; Total caries removal; Definitive restoration. |
| Alternative Treatment | Experimental | Other: Partial caries removal, Other: Provisional restoration - experimental, Other: Total caries removal, Other: Definitive restorationPartial caries removal; Provisional restoration - experimental; Total caries removal; Definitive restoration. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Molars and pre-molars presenting carious lesions involving 2/3 inner of dentin tissue.
Key exclusion criteria (1 listed)
- Teeth presenting signs of irreversible pulpits or necrose, cervical lesion and/or root exposition, or with carious lesion reaching the pulp.
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 |
|---|---|---|
| Partial caries removalThe caries infected dentin will be removed mantaining the affected caries tissue. | Other | Alternative Treatment, Regular Treatment |
| Provisional restoration - controlAfter partial caries removal, a provisional restoration will be performed using a layer of calcium hydroxide paste covered by a layer of calcium hydroxide cement and resin-modified glass ionomer. | Other | Regular Treatment |
| Provisional restoration - experimentalAfter partial caries removal, a provisional restoration will be performed using only resin-modified glass ionomer. | Other | Alternative Treatment |
| Total caries removalAfter two months of their placement, the provisional restoration will removed followed by tota caries tissue removal. | Other | Alternative Treatment, Regular Treatment |
| Definitive restorationDefinite restoration will be performed using composite. | Other | Alternative Treatment, Regular Treatment |
Primary outcome
Tooth vitality - analysis for positive or negative response
Time frame: 2 months after placement of provisional restoration
4 secondary outcomes
Consistency of dentin tissue - scores of 1 (softned) to 4 (hard)
Time frame: Immediately after caries removal
Coloration of dentin tissue - scores of 1 (clear yellow) to 5 (darkd)
Time frame: Immediately after caries removal
Counting of Streptococcus mutans colonies - number of colony-forming units (CFUs)
Time frame: Immediately after caries removal
Counting of Lactobacillus spp colonies - number of colony-forming units (CFUs)
Time frame: Immediately after caries removal
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 3 May 2017.
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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 Partial caries removal, Provisional restoration - experimental and Total caries removal in people with Caries, Dental and Pulpitis, run by Universidade Federal de Sergipe 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 3 May 2017. 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?
Tooth vitality - analysis for positive or negative response (time frame: 2 months after placement of provisional restoration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2017.