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N/A N=98 Randomized Double-blind Other

Clinical Comparison of Vital Pulp Capping Restorative Protocols

Deep Dental Caries

Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Success Rate Based on Pulp Vitality Tests (Vital/Non Vital) — 96.2; 100; 100; 86 Percentage of success rate — p=>0.1

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
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)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Illinois at Chicago
Primary completion
Jul 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Success Rate Based on Pulp Vitality Tests (Vital/Non Vital)
96.2; 100; 100; 86; 100 >0.1
PRIMARY
Pain Assessment Using Visual Analog Pain Scale (VAS) Scale.
0; 0.7; 1.6; 0; 0

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.

Eligibility Criteria

Inclusion Criteria

Clinical inclusion criteria:

  • Adults in good general health between 18 and 64 years of age;
  • Active carious lesions deep into dentin (75% or more of dentin) involving occlusal/incisal and/or proximal surfaces of permanent teeth;
  • Absence of clinical symptoms of irreversible pulpitis (spontaneous pain);
  • Absence of periapical pathology, sinus tract, swelling or abnormal mobility;
  • Restorable teeth.

Radiographic inclusion criteria:

  • Extension of carious lesion close to potential exposure upon excavation (within the D3 region - lesion extending 2/3 within dentin); with the presence of a well-defined radiodense zone between the lesion and the pulp;
  • Absence of periapical radiolucency;
  • Absence of thickening of the periodontal ligament,
  • Absence of resorptive defects.

Exclusion Criteria

  • Non restorable teeth;
  • Teeth with:
  • Recent trauma (within 6 months);
  • Calcified root canals;
  • Periapical radiolucency;
  • Patients experiencing spontaneous moderate to severe pain;
  • Patients that are pregnant or planning to become pregnant in the next year.
  • Patients taking analgesics, anti-inflammatory, or antidepressant medications;
  • Patients with orthodontic treatment;
  • Newly erupted teeth.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02635867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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