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NCT02635867 · ClinicalTrials.gov registry record · NA
Clinical Comparison of Vital Pulp Capping Restorative Protocols
A NA study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- NA
- Development phase
- 109
- Enrollment target
NCT02635867: Completed NA study, sponsored by University of Illinois at Chicago.
NCT02635867 is a NA study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 109 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02635867, a NA study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 109 participants
- Enrollment target
Study Summary
At present, dentistry aims for conservative treatments with the goal of maintaining as much tooth structure as possible. Dental caries remains the most prevalent chronic disease worldwide; these lesions can progress rapidly and reach deeper areas of the tooth. The carious lesion is considered deep when it goes through the main tissues of the tooth, and it can affect the pulp tissue, where the nerve and nutrients of the tooth are located. There are many treatment options for deep carious lesions and they vary by the clinical scenario. Vital pulp therapy has become a fairly predictable alternative treatment to pulpectomy (root canal therapy). The goal of vital pulp capping therapies is to keep the pulp of the teeth vital to prevent further interventions such as root canal treatments and complex restorative work. There are two main clinical scenarios when treating these lesions, depending on the remaining dentin thickness between the carious lesion and the pulp: vital direct and indirect pulp capping. Direct and indirect vital pulp therapies are routinely performed using different clinical protocols. The clinical protocols are selected based on the remaining dentin (between the tooth preparation and pulp) and the restorative materials. There are few studies that evaluate pulp capping method in adult teeth (permanent dentition); many studies have investigated baby teeth (deciduous teeth). Routine therapies include the using of adhesive restorations with and without an intermediate layer of restorative material. Calcium hydroxide based cements have been used for pulp capping as an intermediate layer of restorative material. More recently a new intermediate layer of restorative material composed of resin-modified calcium silicate has been indicated for use on direct and indirect pulp capping. The aims of this study are to compare, over a period of 12 months, the post-operative sensitivity and pulp vitality of three indirect pulp capping protocols and two direct pulp cappi
Primary Outcome
The success rate was based on 3 measures of pulp vitality that resulted in a diagnosis of vital or nonvital after 12-month follow-up: Vital: (1) palpation ="negative" response. (2) percussion = "negative" response. (3) response to cold stimuli= positive \[response time (seconds). Non vital: (1) palpation ="positive" response. (2) percussion = "positive"" response. (3) response to cold stimuli= positive or delayed \[response time (seconds) and lingering (seconds).
Interventions
- PROCEDURE Indirect Pulp capping-Resin-modified calcium silicate - TheraCal
- PROCEDURE Indirect Pulp capping-Calcium hydroxide - Dycal
- PROCEDURE Indirect Pulp capping-Resin-based dentin bonding agent
- PROCEDURE Direct Pulp capping-Resin-modified calcium silicate - TheraCal
- PROCEDURE Direct Pulp capping-Calcium hydroxide - Dycal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2015-06 |
| Est. Completion | 2019-08 |
| Phase | NA |
What the finished NCT02635867 record still lists
NCT02635867 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which Indirect Pulp capping-Resin-modified calcium silicate - TheraCal is the first listed.
NCT02635867 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02635867 about?
NCT02635867 is a clinical study titled "Clinical Comparison of Vital Pulp Capping Restorative Protocols". At present, dentistry aims for conservative treatments with the goal of maintaining as much tooth structure as possible. Dental caries remains the most prevalent chronic disease worldwide; these lesions can progress rapidly and reach deeper areas of the tooth. The carious lesion is considered deep w...
What is the current status of trial NCT02635867?
This trial is currently completed. It is a NA study. The enrollment target is 109 participants. The study started on 2015-06. Estimated completion is 2019-08.
What interventions are being tested in trial NCT02635867?
The interventions under investigation include: Indirect Pulp capping-Resin-modified calcium silicate - TheraCal (PROCEDURE), Indirect Pulp capping-Calcium hydroxide - Dycal (PROCEDURE), Indirect Pulp capping-Resin-based dentin bonding agent (PROCEDURE), Direct Pulp capping-Resin-modified calcium silicate - TheraCal (PROCEDURE), Direct Pulp capping-Calcium hydroxide - Dycal (PROCEDURE).
Who is sponsoring clinical trial NCT02635867?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02635867's enrollment target sits among peer trials
109 825th of 2000 higher than 1,176 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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