At a glance
ClinicalIndex Comparison Record- ✓Adults aged 18-64 in good general health
- ✓Active deep carious lesions extending ≥75% into dentin on occlusal/incisal and/or proximal surfaces of permanent teeth
- ✓No clinical symptoms of irreversible pulpitis (no spontaneous pain)
- ✓No periapical pathology, sinus tract, swelling, or abnormal tooth mobility
- ✕Non-restorable teeth
- ✕Recent tooth trauma within 6 months
- ✕Teeth with calcified root canals
- ✕Periapical radiolucency
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Comparison of Vital Pulp Capping Restorative Protocols: A Randomized Controlled Double-Blind, Prospective Study
In Brief
A clinical study evaluating Indirect Pulp capping-Resin-modified calcium silicate - TheraCal, Indirect Pulp capping-Calcium hydroxide - Dycal, and 3 other interventions for Deep Dental Caries. Completed, enrolled 109 participants across 1 site.
Detailed 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 capping protocol in vital teeth. This study will provide the necessary evidence to allow clinicians to select the best restorative protocol when treating deep carious lesions where indirect and direct pulp capping protocol are needed.
Study Details
Timeline
Interventions
Use of a dental restorative protocol using Resin-modified calcium silicate - TheraCal pulp capping restorative material
Use of a dental restorative protocol using Calcium hydroxide - Dycal pulp capping restorative material
Use of a dental restorative protocol using resin-based dentin bonding system only
Use of a dental restorative protocol using Resin-modified calcium silicate - TheraCal pulp capping restorative material
\\Use of a dental restorative protocol using Calcium hydroxide - Dycal pulp capping restorative material