CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 141 enrolled
Drug / intervention
Selective removal to soft dentin (SRSD) +1 moreprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04052685
NCT04052685N/ACompleted

Selective Removal to Soft Dentine or Selective Removal to Firm Dentine for Deep Caries Lesions in Permanent Posterior Teeth: A Randomized Controlled Trial up to 5 Years

burcu gözetici·interventional·Posted Aug 12, 2019·Updated Jun 21, 2024

In Brief

A clinical study evaluating Selective removal to soft dentin (SRSD) and Selective removal to firm dentine (SRFD) for Deep Caries and 2 related conditions. Completed, enrolled 141 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 12, 2019
Enrollment StartNov 28, 2018
Primary CompletionMar 3, 2020
Study CompletionJun 20, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.9 years ago

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.

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.