Selective Removal to Soft Dentine vs Selective Removal to Firm Dentine for Deep Posterior Caries Lesions

NCT04052685 | Completed DMC

• 1 other identifier: 10840098-604.01.01-E.53565
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

Removal of infected dentin contaminated with bacteria and remaining affected dentin detected as firm is the conventional strategy for the management of cavitated caries lesions. Recently, this strategy is termed as selective removal to firm dentin (SRFD) and seems to increase the potential risk of pulp exposure or loss of pulp vitality for deep caries lesions radiographically extending ¾ of dentin tissue. Alternatively, selective removal to soft dentine (SRSD) that refers to removal of caries tissue at the periphery of the cavity to firm dentin and remaining caries tissue detected as soft or leathery in proximity with the pulp might be a less invasive excavation method for deep caries lesions to maintain pulpal health. However, information on clinical advantages or disadvantages of SRSD and SRFD excavation methods is sparse and mostly rely on studies conducted for primary teeth. Moreover, clinical trials are needed to demonstrate the combined effect of carious removal strategies and calcium silicate-based materials. The aim of this study is comparison of clinical success rates of SRSD and SRFD techniques in posterior deep caries lesions. The primary outcome of the study is comparison of clinical success of SRSD and SRFD techniques by clinical and radiographic examination after 3 months, 6 months, 1 year and 2 years. The secondary outcome of the study is to investigate whether or not calcium silicate-based materials have an effect on the success rate of the treatment.

Conditions

Deep Caries; Pulp Exposure, Dental; Dental Caries

Outcome Measures

Primary Outcomes (2)

• Success (endodontic treatment required no/yes)

  The primary outcome of the study will be success (i. e. not requiring root canal treatment intervention). Pulp vitality (yes/no), pain on percussion or palpation (yes/no), presence of abscess or fistula (yes/no) will assessed clinically. Radiographically, periradicular pathology (yes/no), pathologic calcification or resorption (yes/no) will be assessed.

  60 months

• Post-operative sensitivity (yes/no)

  The second outcome of the study will depend on Patients' subjective assessment of the treatment (severe/moderate/no)

  60 months

Secondary Outcomes (2)

• Dentin bridge formation

  60 months

• Restoration integrity

  60 months

Study Arms (2)

Selective removal to soft dentin (SRSD)

EXPERIMENTAL

The patients in SRSD group will be randomized into two subgroups as Group A and Group C. After caries removal to soft dentin calcium silicate based material (Biodentine) will be applied in Group A while will not be applied in Group C prior to placement of the resin composite restoration. The procedure, starts with access to caries tissue by the removal of surrounding unsupported enamel.Carious tissue at the periphery of the cavity will be prepared to hard dentin using round tungsten carbide burs and/or an excavator, while soft carious dentin will remain in the pulpal aspect of the cavity to prevent pulp exposure. Operative procedures will be performed by an experienced (over 10 years) specialist. Moisture control will be provided using cotton rolls and continuous aspiration.

Procedure: Selective removal to soft dentin (SRSD)

Selective removal to firm dentin (SRSD)

ACTIVE COMPARATOR

Procedures will be done using local anesthesia. The procedure, starts with access to caries tissue by the removal of surrounding unsupported enamel. Caries tissue in the periphery including the enamel-dentinal junction will be removed using round tungsten carbide burs and/or an excavator until hard, dry dentin remains. Pulpo-proximal caries tissue will be removed until hard or leathery dentin remains. Operative procedures will be performed by an experienced (over 10 years) specialist. Moisture control will be provided using cotton rolls and continuous aspiration. Restoration will be performed after caries removal to firm dentin and placement of calcium silicate based material (Biodentine).

Procedure: Selective removal to firm dentine (SRFD)

Interventions

Selective removal to soft dentin (SRSD) PROCEDURE

In order to prevent pulp exposure in deep caries lesions radiographically extending at least 3/4 of dentin, periphery of the cavity prepared to hard dentin while reasonable amount of soft carious tissue over the pulp is left. This caries removal strategy is termed selective removal to soft dentine.

Also known as: Partial caries excavation, Incomplete caries excavation

Selective removal to soft dentin (SRSD)

Selective removal to firm dentine (SRFD) PROCEDURE

Carious tissue is totally removed until hard dentin dry in appearance and hard on probing. This carious removal strategy is strongly recommended for shallow or moderately deep carious lesions.

Also known as: Total caries removal

Selective removal to firm dentin (SRSD)

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Deep primary active caries lesion extending at least 3/4 of dentin
• No irreversible pulpitis symptoms
• Positive response to electrical and cold pulp vitality tests
• Good general health
• No untreated periodontal disease
• Acceptance to be included in study

You may not qualify if:

• Irreversible pulpitis symptoms
• Negative response to electrical and cold pulp vitality tests
• Radiographically periradicular pathology
• Pregnancy
• Teeth with non-carious lesions (attrition, erosion, abrasion or abfraction)
• Patients planning bleaching or orthodontic treatment
• Known allergy to study material

Sponsors & Collaborators

• burcu gözetici: lead
• Istanbul Medipol University Hospital: collaborator

Study Sites (1)

Istanbul Medipol University, School of Dentistry

Istanbul, Turkey (Türkiye)

Location

Related Publications (11)

• Schwendicke F, Frencken JE, Bjorndal L, Maltz M, Manton DJ, Ricketts D, Van Landuyt K, Banerjee A, Campus G, Domejean S, Fontana M, Leal S, Lo E, Machiulskiene V, Schulte A, Splieth C, Zandona AF, Innes NP. Managing Carious Lesions: Consensus Recommendations on Carious Tissue Removal. Adv Dent Res. 2016 May;28(2):58-67. doi: 10.1177/0022034516639271.

  PMID: 27099358 BACKGROUND

• Massler M. Pulpal reactions to dental caries. Int Dent J. 1967 Jun;17(2):441-60. No abstract available.

  PMID: 5233875 BACKGROUND

• Ricketts D, Innes N, Schwendicke F. Selective Removal of Carious Tissue. Monogr Oral Sci. 2018;27:82-91. doi: 10.1159/000487838. Epub 2018 May 24.

  PMID: 29794475 BACKGROUND

• Barthel CR, Rosenkranz B, Leuenberg A, Roulet JF. Pulp capping of carious exposures: treatment outcome after 5 and 10 years: a retrospective study. J Endod. 2000 Sep;26(9):525-8. doi: 10.1097/00004770-200009000-00010.

  PMID: 11199794 BACKGROUND

• Dammaschke T, Leidinger J, Schafer E. Long-term evaluation of direct pulp capping--treatment outcomes over an average period of 6.1 years. Clin Oral Investig. 2010 Oct;14(5):559-67. doi: 10.1007/s00784-009-0326-9. Epub 2009 Aug 15.

  PMID: 19685086 BACKGROUND

• Awawdeh L, Al-Qudah A, Hamouri H, Chakra RJ. Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. J Endod. 2018 Nov;44(11):1603-1609. doi: 10.1016/j.joen.2018.08.004. Epub 2018 Oct 3.

  PMID: 30292451 BACKGROUND

• 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

• Franzon R, Guimaraes LF, Magalhaes CE, Haas AN, Araujo FB. Outcomes of one-step incomplete and complete excavation in primary teeth: a 24-month randomized controlled trial. Caries Res. 2014;48(5):376-83. doi: 10.1159/000357628. Epub 2014 Apr 8.

  PMID: 24732081 BACKGROUND

• Carvalho JC, Dige I, Machiulskiene V, Qvist V, Bakhshandeh A, Fatturi-Parolo C, Maltz M. Occlusal Caries: Biological Approach for Its Diagnosis and Management. Caries Res. 2016;50(6):527-542. doi: 10.1159/000448662. Epub 2016 Sep 23.

  PMID: 27658123 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. J Adhes Dent. 2010 Aug;12(4):259-72. doi: 10.3290/j.jad.a19262.

  PMID: 20847997 BACKGROUND

• Gozetici-Cil B, Erdem-Hepsenoglu Y, Tekin A, Ozcan M. Selective removal to soft dentine or selective removal to firm dentine for deep caries lesions in permanent posterior teeth: a randomized controlled clinical trial up to 2 years. Clin Oral Investig. 2023 May;27(5):2125-2137. doi: 10.1007/s00784-022-04815-0. Epub 2022 Dec 3.

  PMID: 36460919 DERIVED

MeSH Terms

Conditions

Dental Pulp Exposure; Dental Caries

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Tooth Demineralization

Study Officials

• Burcu Gözetici Çil, DDS, PhD

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 12, 2019
• Study Start: November 28, 2018
• Primary Completion: March 3, 2020
• Study Completion: June 20, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

TU (1)