- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04250142
Pulp Protection in Selective Carious Tissue Removal (PULPROTECT)
December 26, 2022 updated by: Rodrigo A. Giacaman, DDS, PhD, University of Talca
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
142
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
No State
-
Talca, No State, Chile, 3460000
- Faculty of Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Systemic conditions with poor control or uncompensated.
- Cervical margin of the cavity in dentin or root cement.
- Tooth already restored or with secondary caries.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventional Glass Ionomer
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.
|
A conventional glass ionomer will be used to cover deep carious dentin after a selective removal of caries lesion to soft dentin procedure.
Other Names:
|
Experimental: Self-etching Adhesive
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.
|
A Self-etching adhesive will be used to cover deep carious dentin after a selective removal of caries lesion to soft dentin procedure.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Restoration integrity
Time Frame: 2 years
|
The FDI Criteria will be used for the direct clinical evaluation of restorations.
|
2 years
|
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 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiographic progression
Time Frame: 2 years
|
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.
|
2 years
|
Changes in pulp chamber morphology
Time Frame: 2 years
|
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.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Cecilia Muñoz Sandoval, DDS, University of Talca
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hickel 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.
- 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.
- Bjorndal 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.
- Maltz 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.
- Bjorndal 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2019
Primary Completion (Actual)
December 23, 2021
Study Completion (Actual)
March 18, 2022
Study Registration Dates
First Submitted
January 29, 2020
First Submitted That Met QC Criteria
January 30, 2020
First Posted (Actual)
January 31, 2020
Study Record Updates
Last Update Posted (Actual)
December 28, 2022
Last Update Submitted That Met QC Criteria
December 26, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Tooth Demineralization
- Tooth Diseases
- Dental Caries
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Methamphetamine
Other Study ID Numbers
- CM-11/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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