Dental CariesPULPROTECTNCT04250142
Pulp Protection in Selective Carious Tissue Removal
A study testing Self-etching Adhesive and Glass Ionomer in people with Dental Caries, run by University of Talca at 1 site in Chile.
Trial summary
Although selective removal of carious tissue to soft dentin (SRCT-S) has been proposed as the standard of care for the management of deep dentin caries, it is unclear whether a cavity liner is necessary. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Self-etching Adhesive and Glass Ionomer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteChile
- Study dates
- 13 Mar 2019to 18 Mar 2022
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with a permanent molar or premolar with a deep caries lesion that compromises from the inner half of the dentin (determined by radiographic examination).
- Tooth restorable by a direct resin restoration.
- Absence of pulp sensibility verified by cold test
- Absence of a history of spontaneous pain or vertical and horizontal percussion.
- Absence of periapical lesion, verified through periapical radiographs.
- Primary injury.
Who cannot join
- Systemic conditions with poor control or uncompensated.
- Cervical margin of the cavity in dentin or root cement.
- Tooth already restored or with secondary caries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pulp Protection After Selective Carious Tissue Removal in Permanent Teeth, a Randomized Controlled Clinical Trial
Although selective removal of carious tissue to soft dentin (SRCT-S) has been proposed as the standard of care for the management of deep dentin caries, it is unclear whether a cavity liner is necessary. This double blinded randomized controlled clinical trial aims to analyze the behavior of a resin restoration performed after SRCT-S for deep dentin caries, treated either with a Glass Ionomer or only with a Self-Etching Adhesive, in permanent teeth. The study will include 142 restorations allocated to either experimental arm. After 12 and 24 months, restoration survival, pulp response and radiographic lesion progression will be assessed.
Read the detailed description
Introduction: Minimally invasive dentistry has been proposed as an conceptual framework for the conservative management of caries lesions. This approach allows reducing potential adverse effects derived from the conventional treatment, including the loss of pulp vitality. Complete removal carious tissues compromising deep dentin significantly increases the risk of pulp exposure and post-operative symptoms, leading in many cases, to the need for endodontic treatment, with the subsequent high costs and low coverage for the population. In this context, a new technique for the management of deep caries lesions has been introduced called selective removal of carious tissue to soft dentin (SRCT-S), which partially removes only the outer layer of the affected tissue, leaving carious tissue in the pulpal wall, but not on the lateral walls of the operatory cavity. This procedure has been reported in several studies, with lower clinical time, cheaper cost and lower discomfort for the patient. The SRCT-S aims to preserve pulp vitality, prevent access of nutrients to carious tissue, stopping the caries process and preserving a greater amount of dental structure. Although the SRCT-S technique has proven effective compared to conventional treatments, it is unclear and with insufficient evidence about how to manage the remaining carious tissue and whether a cavity lining agent is needed. This decision may have important clinical implications, but there is no general consensus, strongly suggesting further research. Objective: To analyze the behavior of a resin restoration performed after SRCT-S for deep dentin caries, treated either with a Glass Ionomer or only with a Self-Etching Adhesive, in permanent teeth. Methodology: A double blinded randomized controlled clinical trial was devised. Trained dentists will treat the 142 restorations included in deep dentin carious lesions of permanent molars, at the dental clinics of the University of Talca. After recruiting, patients will be randomly assigned to the experimental groups: Group 1: (n=71) no cavity lining, treating carious tissue with self-conditioning adhesive followed by composite resin restoration and Group 2: (n=71) remaining carious tissue covered with a conventional glass ionomer followed by composite resin restoration. The dependent variables (outcomes) will be; a. clinical: restoration survival and pulp response and b. radiographic: lesion progression. Clinical and radiographic outcomes will be monitored annually at 12 and 24 months. The analysis of the restorations and the pulp response will be performed with Weibull regression. The Friedman test will be applied for the analysis of the data regarding radiographic subtraction, (p≤0.05). Given the lack of studies on the subject with longitudinal evaluations, this project is expected to contribute relevant evidence that impacts the generation of novel guidelines for the management of deep dentin caries. Additionally, the results will contribute evidence to increase the support to a more conservative clinical behavior.
- Conditions
- Dental Caries
- Being tested
- Self-etching Adhesive, Glass Ionomer
- Keywords
- Dental caries, Selective Caries Removal, Self-etching adhesive, Composite Resin, Glass ionomer, Cavity lining, Minimally invasive dentistry, Deep caries lesions
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-etching AdhesiveDevice
Also called Self-conditioning Adhesive, Self-etching primer, Single Bond Universal (3M)
A Self-etching adhesive will be used to cover deep carious dentin after a selective removal of caries lesion to soft dentin procedure.
Glass IonomerDevice
Also called Conventional Glass Ionomer, Ketac Molar (3M)
A conventional glass ionomer will be used to cover deep carious dentin after a selective removal of caries lesion to soft dentin procedure.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Glass Ionomer | Active comparator | Selective removal of carious tissue to soft dentin. Deep carious dentin will be lined by a conventional glass ionomer, followed by a composite resin restoration. Receives: Device: Glass Ionomer |
| Self-etching Adhesive | Experimental | Selective removal of carious tissue to soft dentin. Deep carious dentin will not be lined and a self-etching adhesive will cover the tissue, followed by a composite resin restoration. Receives: Device: Self-etching Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration integrity
The FDI Criteria will be used for the direct clinical evaluation of restorations.
Measured: 2 years
Pulp vitality
Pulp vitality will be evaluated by means of symptoms reported by the patient, normal response upon thermal tests, no pain upon percussion, absence of periapical lesions (periapical radiography) and absence of infectious processes such as fistula.
Measured: 2 years
Secondary outcomes (2)
Radiographic progression
Lesion progression at the x-ray will be monitored through qualitative analysis with the technique of digital subtraction of the radiographic images (radiolucent area under restorations) over time.
Measured: 2 years
Changes in pulp chamber morphology
For the qualitative analysis of the depth of the lesion and the deposition of tertiary dentin, the pairs of radiographic images (baseline radiographs versus control radiographs) will be assessed and compared.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start13 Mar 2019
- Primary completion23 Dec 2021
- Study completion18 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Model description
- A double blinded randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Talca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo A. Giacaman, DDS, PhD, University of Talca
- Investigators
- Cecilia Muñoz Sandoval, DDS, Study director, University of Talca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250142
- Sponsor's protocol ID
- CM-11/2018
- Acronym
- PULPROTECT
- Status last verified
- Dec 2022
- First submitted
- 29 Jan 2020
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Maltz M, Alves LS, Jardim JJ, Moura Mdos S, de Oliveira EF. Incomplete caries removal in deep lesions: a 10-year prospective study. Am J Dent. 2011 Aug;24(4):211-4.
PubMed 22016914Maltz M, Koppe B, Jardim JJ, Alves LS, de Paula LM, Yamaguti PM, Almeida JCF, Moura MS, Mestrinho HD. Partial caries removal in deep caries lesions: a 5-year multicenter randomized controlled trial. Clin Oral Investig. 2018 Apr;22(3):1337-1343. doi: 10.1007/s00784-017-2221-0. Epub 2017 Oct 8.
PubMed 28988345Bjorndal L, Reit C, Bruun G, Markvart M, Kjaeldgaard M, Nasman P, Thordrup M, Dige I, Nyvad B, Fransson H, Lager A, Ericson D, Petersson K, Olsson J, Santimano EM, Wennstrom A, Winkel P, Gluud C. Treatment of deep caries lesions in adults: randomized clinical trials comparing stepwise vs. direct complete excavation, and direct pulp capping vs. partial pulpotomy. Eur J Oral Sci. 2010 Jun;118(3):290-7. doi: 10.1111/j.1600-0722.2010.00731.x.
PubMed 20572864Bjorndal L, Fransson H, Bruun G, Markvart M, Kjaeldgaard M, Nasman P, Hedenbjork-Lager A, Dige I, Thordrup M. Randomized Clinical Trials on Deep Carious Lesions: 5-Year Follow-up. J Dent Res. 2017 Jul;96(7):747-753. doi: 10.1177/0022034517702620. Epub 2017 Apr 14.
PubMed 28410008Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
PubMed 20628774
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulp Protection After Selective Carious Tissue Removal in Permanent Teeth, a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04250142
- Acronym / sponsor ID
- PULPROTECT / CM-11/2018
- Conditions
- Dental Caries
- Keywords
- Dental caries, Selective Caries Removal, Self-etching adhesive, Composite Resin, Glass ionomer, Cavity lining, Minimally invasive dentistry, Deep caries lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of TalcaUniversity, hospital or other
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 31 Jan 2020 (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.
Although selective removal of carious tissue to soft dentin (SRCT-S) has been proposed as the standard of care for the management of deep dentin caries, it is unclear whether a cavity liner is necessary. This double blinded randomized controlled clinical trial aims to analyze the behavior of a resin restoration performed after SRCT-S for deep dentin caries, treated either with a Glass Ionomer or only with a Self-Etching Adhesive, in permanent teeth. The study will include 142 restorations allocated to either experimental arm. After 12 and 24 months, restoration survival, pulp response and radiographic lesion progression will be assessed.
Detailed description
Introduction: Minimally invasive dentistry has been proposed as an conceptual framework for the conservative management of caries lesions. This approach allows reducing potential adverse effects derived from the conventional treatment, including the loss of pulp vitality. Complete removal carious tissues compromising deep dentin significantly increases the risk of pulp exposure and post-operative symptoms, leading in many cases, to the need for endodontic treatment, with the subsequent high costs and low coverage for the population. In this context, a new technique for the management of deep caries lesions has been introduced called selective removal of carious tissue to soft dentin (SRCT-S), which partially removes only the outer layer of the affected tissue, leaving carious tissue in the pulpal wall, but not on the lateral walls of the operatory cavity. This procedure has been reported in several studies, with lower clinical time, cheaper cost and lower discomfort for the patient. The SRCT-S aims to preserve pulp vitality, prevent access of nutrients to carious tissue, stopping the caries process and preserving a greater amount of dental structure. Although the SRCT-S technique has proven effective compared to conventional treatments, it is unclear and with insufficient evidence about how to manage the remaining carious tissue and whether a cavity lining agent is needed. This decision may have important clinical implications, but there is no general consensus, strongly suggesting further research. Objective: To analyze the behavior of a resin restoration performed after SRCT-S for deep dentin caries, treated either with a Glass Ionomer or only with a Self-Etching Adhesive, in permanent teeth. Methodology: A double blinded randomized controlled clinical trial was devised. Trained dentists will treat the 142 restorations included in deep dentin carious lesions of permanent molars, at the dental clinics of the University of Talca. After recruiting, patients will be randomly assigned to the experimental groups: Group 1: (n=71) no cavity lining, treating carious tissue with self-conditioning adhesive followed by composite resin restoration and Group 2: (n=71) remaining carious tissue covered with a conventional glass ionomer followed by composite resin restoration. The dependent variables (outcomes) will be; a. clinical: restoration survival and pulp response and b. radiographic: lesion progression. Clinical and radiographic outcomes will be monitored annually at 12 and 24 months. The analysis of the restorations and the pulp response will be performed with Weibull regression. The Friedman test will be applied for the analysis of the data regarding radiographic subtraction, (p≤0.05). Given the lack of studies on the subject with longitudinal evaluations, this project is expected to contribute relevant evidence that impacts the generation of novel guidelines for the management of deep dentin caries. Additionally, the results will contribute evidence to increase the support to a more conservative clinical behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A double blinded randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Conventional Glass Ionomer | Active comparator | Device: Glass IonomerSelective removal of carious tissue to soft dentin. Deep carious dentin will be lined by a conventional glass ionomer, followed by a composite resin restoration. |
| Self-etching Adhesive | Experimental | Device: Self-etching AdhesiveSelective removal of carious tissue to soft dentin. Deep carious dentin will not be lined and a self-etching adhesive will cover the tissue, followed by a composite resin restoration. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a permanent molar or premolar with a deep caries lesion that compromises from the inner half of the dentin (determined by radiographic examination).
- Tooth restorable by a direct resin restoration.
- Absence of pulp sensibility verified by cold test
- Absence of a history of spontaneous pain or vertical and horizontal percussion.
- Absence of periapical lesion, verified through periapical radiographs.
Key exclusion criteria (3 listed)
- Systemic conditions with poor control or uncompensated.
- Cervical margin of the cavity in dentin or root cement.
- Tooth already restored or with secondary caries.
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 |
|---|---|---|
| Self-etching AdhesiveAlso: Self-conditioning Adhesive, Self-etching primer, Single Bond Universal (3M)A Self-etching adhesive will be used to cover deep carious dentin after a selective removal of caries lesion to soft dentin procedure. | Device | Self-etching Adhesive |
| Glass IonomerAlso: Conventional Glass Ionomer, Ketac Molar (3M)A conventional glass ionomer will be used to cover deep carious dentin after a selective removal of caries lesion to soft dentin procedure. | Device | Conventional Glass Ionomer |
Primary outcome
Restoration integrity
Time frame: 2 years
The FDI Criteria will be used for the direct clinical evaluation of restorations.
Pulp vitality
Time frame: 2 years
Pulp vitality will be evaluated by means of symptoms reported by the patient, normal response upon thermal tests, no pain upon percussion, absence of periapical lesions (periapical radiography) and absence of infectious processes such as fistula.
2 secondary outcomes
Radiographic progression
Time frame: 2 years
Changes in pulp chamber morphology
Time frame: 2 years
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 28 Dec 2022.
- Background: PubMed 22016914Maltz M, Alves LS, Jardim JJ, Moura Mdos S, de Oliveira EF. Incomplete caries removal in deep lesions: a 10-year prospective study. Am J Dent. 2011 Aug;24(4):211-4.
- Background: PubMed 28988345Maltz M, Koppe B, Jardim JJ, Alves LS, de Paula LM, Yamaguti PM, Almeida JCF, Moura MS, Mestrinho HD. Partial caries removal in deep caries lesions: a 5-year multicenter randomized controlled trial. Clin Oral Investig. 2018 Apr;22(3):1337-1343. doi: 10.1007/s00784-017-2221-0. Epub 2017 Oct 8.
- Background: PubMed 20572864Bjorndal L, Reit C, Bruun G, Markvart M, Kjaeldgaard M, Nasman P, Thordrup M, Dige I, Nyvad B, Fransson H, Lager A, Ericson D, Petersson K, Olsson J, Santimano EM, Wennstrom A, Winkel P, Gluud C. Treatment of deep caries lesions in adults: randomized clinical trials comparing stepwise vs. direct complete excavation, and direct pulp capping vs. partial pulpotomy. Eur J Oral Sci. 2010 Jun;118(3):290-7. doi: 10.1111/j.1600-0722.2010.00731.x.
- Background: PubMed 28410008Bjorndal L, Fransson H, Bruun G, Markvart M, Kjaeldgaard M, Nasman P, Hedenbjork-Lager A, Dige I, Thordrup M. Randomized Clinical Trials on Deep Carious Lesions: 5-Year Follow-up. J Dent Res. 2017 Jul;96(7):747-753. doi: 10.1177/0022034517702620. Epub 2017 Apr 14.
- Background: PubMed 20628774Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
- 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. This study is not recruiting at the moment.
Cecilia Muñoz Sandoval, DDS study director
University of Talca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-etching Adhesive and Glass Ionomer in people with Dental Caries, run by University of Talca at 1 site in Chile.
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 6 inclusion and 3 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 28 Dec 2022. 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 Chile. 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?
Restoration integrity (time frame: 2 years). The study lists 2 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 NCT04250142, which also lists 5 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 28 Dec 2022.