Clinical Comparison of Vital Pulp Capping Restorative Protocols
1 other identifier
interventional
109
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 8, 2015
CompletedFirst Posted
Study publicly available on registry
December 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedResults Posted
Study results publicly available
October 12, 2023
CompletedOctober 12, 2023
December 1, 2022
4.1 years
December 8, 2015
October 6, 2021
December 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Success Rate Based on Pulp Vitality Tests (Vital/Non Vital)
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).
12 months
Pain Assessment Using Visual Analog Pain Scale (VAS) Scale.
All the subjects will be asked to answer one question tracing a line on a hard copy visual analogue scale within a centimeters scale (0-10 cm) The measurement was quantitative (cm). The subject is asked to rate the level of pain by drawing a line in a 10 cm line, 0 being no pain, 10 being the worst pain.
12 months
Study Arms (5)
Indirect pulp capping therapy-Resin-modified calcium silicate - TheraCal
ACTIVE COMPARATORResin modified calcium silicate-TheraCal (light curable)
Indirect pulp capping therapy- - Calcium hydroxide - Dycal
ACTIVE COMPARATORCalcium hydroxide - Dycal
Indirect pulp capping therapy-- Resin-based dentin bonding agent
ACTIVE COMPARATORResin-based dentin bonding agent-Self etching adhesive
Direct pulp capping therapy-Resin-modified calcium silicate - TheraCal
ACTIVE COMPARATORResin modified calcium silicate-TheraCal (Light curable)
Direct pulp capping therapy-Resin-modified calcium silicate - Calcium hydroxide - Dycal
ACTIVE COMPARATOR\- Calcium hydroxide - Dycal
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
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois at Chicago College of Dentistry
Chicago, Illinois, 60612, United States
Limitations and Caveats
Not all participants completed 100% of the follow-ups. Limited numbers of participants in the direct pulp capping study arm
Results Point of Contact
- Title
- Adriana Semprum-Clavier
- Organization
- University of Illinois at Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 8, 2015
First Posted
December 21, 2015
Study Start
June 1, 2015
Primary Completion
July 1, 2019
Study Completion
August 1, 2019
Last Updated
October 12, 2023
Results First Posted
October 12, 2023
Record last verified: 2022-12