Last reviewed · How we verify

NCT04052685

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

Completed NA Last updated 21 June 2024
What this trial tests

NA trial testing Selective removal to soft dentin (SRSD) in Deep Caries in 141 participants. Completed in 20 June 2024.

Timeline
28 November 2018
Primary endpoint
3 March 2020
20 June 2024

Quick facts

Lead sponsorburcu gözetici
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment141
Start date28 November 2018
Primary completion3 March 2020
Estimated completion20 June 2024
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

burcu gözetici

Who can join

Adults 13 to 65, any sex, with Deep Caries or Pulp Exposure, Dental. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Selective removal to soft dentine or selective removal to firm dentine for deep caries lesions ın permanent posterior teeth: a randomized controlled clinical trial up to 2 years.
    Gözetici-Çil B, Erdem-Hepşenoğlu Y, Tekin A, Özcan M. · · 2023 · cited 15× · PMID 36460919 · DOI 10.1007/s00784-022-04815-0

Verify or expand the search:

Other recruiting trials for Deep Caries

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04052685.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing