Pulp Protection in Selective Carious Tissue Removal

NCT04250142 | Completed FDA Device

• 1 other identifier: CM-11/2018
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

Dental caries; Selective Caries Removal; Self-etching adhesive; Composite Resin; Glass ionomer; Cavity lining; Minimally invasive dentistry; Deep caries lesions

Outcome Measures

Primary Outcomes (2)

• Restoration integrity

  The FDI Criteria will be used for the direct clinical evaluation of restorations.

  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.

  2 years

Secondary Outcomes (2)

• Radiographic progression

  2 years

• Changes in pulp chamber morphology

  2 years

Study Arms (2)

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.

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.

Device: Self-etching Adhesive

Interventions

Self-etching Adhesive DEVICE

A Self-etching adhesive will be used to cover deep carious dentin after a selective removal of caries lesion to soft dentin procedure.

Also known as: Self-conditioning Adhesive, Self-etching primer, Single Bond Universal (3M)

Self-etching Adhesive

Glass Ionomer DEVICE

A conventional glass ionomer will be used to cover deep carious dentin after a selective removal of caries lesion to soft dentin procedure.

Also known as: Conventional Glass Ionomer, Ketac Molar (3M)

Conventional Glass Ionomer

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Systemic conditions with poor control or uncompensated.
• Cervical margin of the cavity in dentin or root cement.
• Tooth already restored or with secondary caries.

Sponsors & Collaborators

• University of Talca: lead

Study Sites (1)

Faculty of Health Sciences

Talca, No State, 3460000, Chile

Location

Related Publications (5)

• 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.

  PMID: 22016914 BACKGROUND

• 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.

  PMID: 28988345 BACKGROUND

• 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.

  PMID: 20572864 BACKGROUND

• 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.

  PMID: 28410008 BACKGROUND

• 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.

  PMID: 20628774 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Cecilia Muñoz Sandoval, DDS

  University of Talca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: A double blinded randomized controlled clinical trial

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: March 13, 2019
• Primary Completion: December 23, 2021
• Study Completion: March 18, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)