Brief Summary

The study involved 54 adult patients between the ages of 18 and 50 years who had a posterior permanent tooth with a deep occlusal (Class I) carious lesion that extended to the inner third of the dentin (D3) and divided them into two equal groups randomly (N=27) according to the caries removal technique: group 1 (SE), and group 2 (SW). Then each main group was equally subdivided into three equal subgroups (n=9) according to the applied dentin dressing material as follows: Subgroup 1: Nano-silver compound (NSC), Subgroup 2: Chitosan-loaded nano hydroxy apatite (CS/N-HAp), Subgroup 3: Bioactive glass ionomer (N-BAG/GIC). At the first visit both groups received the same treatment of incomplete caries excavation, application of dentin dressing materials and sealing temporarily for 3-months with a glass ionomer cement (GIC). At the second visit the GIC reduced pulpally in (SE) group leaving 2 mm as base and completely removal the remaining carious lesion in (SW) group then re-application of same dentin dressing material on each tooth and GIC as a base. Finally, all cavities were restored with selective enamel etching technique, after which self-etch adhesive and Nano-filled composite resin are applied according to manufacturer instructions. The clinical and digital radiographic evaluations of the success and failure rates were performed at: baseline (7 days), 3, 12, and 18-months.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Feb 2023

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.5 years study duration

Study Start

First participant enrolled

February 1, 2023

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2024

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2024

Completed

Last Updated

September 5, 2024

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

September 3, 2024

Last Update Submit

September 3, 2024

Conditions

Caries Arrested

Outcome Measures

Primary Outcomes (4)

post operative pain
evaluation of the post operative pain following restorations using modified USPHS
7 days
post operative pain
evaluation of the post operative pain following restorations using modified USPHS
3 months
post operative pain
evaluation of the post operative pain following restorations using modified USPHS
12 months
post operative pain
evaluation of the post operative pain following restorations using modified USPHS
18 months