PULPROTECT: Pulp Protection in Selective Carious Tissue Removal

Sponsor

University of Talca (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04250142

Collaborator

(none)

142

Enrollment

Location

Arms

36.2

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Device: Self-etching Adhesive Device: Glass Ionomer	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

142 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A double blinded randomized controlled clinical trialA double blinded randomized controlled clinical trial

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Subjects will not know the type of treatment they will receive. The data analysis will be carried out assigning a letter to the treatment arms, and the identity of the arms will not be revealed up until the end of the analysis.

Primary Purpose:

Treatment

Official Title:

Effect of Pulp Protection After Selective Carious Tissue Removal in Permanent Teeth, a Randomized Controlled Clinical Trial

Actual Study Start Date :

Mar 13, 2019

Anticipated Primary Completion Date :

Dec 23, 2021

Anticipated Study Completion Date :

Mar 18, 2022

Arms and Interventions

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.	Device: Glass Ionomer 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: Conventional Glass Ionomer Ketac Molar (3M)
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.	Device: Self-etching Adhesive 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: Self-conditioning Adhesive Self-etching primer Single Bond Universal (3M)

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.

Device: Glass Ionomer

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:

Conventional Glass Ionomer

Ketac Molar (3M)

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.

Device: Self-etching Adhesive

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:

Self-conditioning Adhesive

Self-etching primer

Single Bond Universal (3M)

Outcome Measures

Primary Outcome Measures

Restoration integrity [2 years]
The FDI Criteria will be used for the direct clinical evaluation of restorations.
Pulp vitality [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.

Secondary Outcome Measures

Radiographic progression [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.
Changes in pulp chamber morphology [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.