Deep Dental CariesNCT02635867
Clinical Comparison of Vital Pulp Capping Restorative Protocols
A study testing Indirect Pulp capping-Resin-modified calcium silicate - TheraCal, Indirect Pulp capping-Calcium hydroxide - Dycal and Indirect Pulp capping-Resin-based dentin bonding agent in people with Deep Dental Caries, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Dental Caries
- What is being tested?
- Indirect Pulp capping-Resin-modified calcium silicate - TheraCal, Indirect Pulp capping-Calcium hydroxide - Dycal and Indirect Pulp capping-Resin-based dentin bonding agent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Non restorable teeth;
- Teeth with:
- Recent trauma (within 6 months);
- Calcified root canals;
- Periapical radiolucency;
- Patients experiencing spontaneous moderate to severe pain;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago College of Dentistry
Chicago, Illinois, 60612
About this study
Official title: Clinical Comparison of Vital Pulp Capping Restorative Protocols: A Randomized Controlled Double-Blind, Prospective Study
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.
Read the detailed description
This randomized, controlled, double-blind, prospective study compares over a period of 12 months, the post-operative sensitivity and pulp vitality of three indirect pulp capping protocols (TheraCal, Bisco; Dycal, Caulk, and no liner). The study was approved by the University of Illinois internal review board (Protocol # 2014-1163). Potential subjects will be screened by one of 3 calibrated investigators through a brief interview and intraoral examination. The screening process includes a medical and dental history, demographics, current/concomitant medication, oral soft and hard tissue examination, 2 radiographs: one periapical and one bitewing, and a review of all inclusion and exclusion criteria. The inclusion criteria consist of adults in good general health between 18 and 64 years of age; with primary active carious lesions deep into the dentin (75% or more of carious dentin) of permanent teeth; absence of clinical symptoms of irreversible pulpitis (spontaneous pain and lingering pain for more than 10 seconds after cold stimulus), and absence of periapical pathology, sinus tract, swelling or abnormal mobility. The outcomes measures are pain using visual analog pain scale (pain assessment form) and success rate (pulp vitality based on percussion, palpation, cold test, radiographic findings), collected at the screening visit, intervention day, 24 hours, 7 days, 3 months, 6 months, and 12 months follow-up visits,
- Conditions
- Deep Dental Caries
- Being tested
- Indirect Pulp capping-Resin-modified calcium silicate - TheraCal, Indirect Pulp capping-Calcium hydroxide - Dycal, Indirect Pulp capping-Resin-based dentin bonding agent, Direct Pulp capping-Resin-modified calcium silicate - TheraCal, Direct Pulp capping-Calcium hydroxide - Dycal
- Keywords
- vital pulp, reversible pulpitis, pulp capping, deep cavity, Management of Deep Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect Pulp capping-Resin-modified calcium silicate - TheraCalProcedure or surgery
Use of a dental restorative protocol using Resin-modified calcium silicate - TheraCal pulp capping restorative material
Indirect Pulp capping-Calcium hydroxide - DycalProcedure or surgery
Use of a dental restorative protocol using Calcium hydroxide - Dycal pulp capping restorative material
Indirect Pulp capping-Resin-based dentin bonding agentProcedure or surgery
Use of a dental restorative protocol using resin-based dentin bonding system only
Direct Pulp capping-Resin-modified calcium silicate - TheraCalProcedure or surgery
Use of a dental restorative protocol using Resin-modified calcium silicate - TheraCal pulp capping restorative material
Direct Pulp capping-Calcium hydroxide - DycalProcedure or surgery
\Use of a dental restorative protocol using Calcium hydroxide - Dycal pulp capping restorative material
| Study group | Role | What they receive |
|---|---|---|
| Indirect pulp capping therapy-Resin-modified calcium silicate - TheraCal | Active comparator | Resin modified calcium silicate-TheraCal (light curable) Receives: Procedure: Indirect Pulp capping-Resin-modified calcium silicate - TheraCal |
| Indirect pulp capping therapy- - Calcium hydroxide - Dycal | Active comparator | Calcium hydroxide - Dycal Receives: Procedure: Indirect Pulp capping-Calcium hydroxide - Dycal |
| Indirect pulp capping therapy-- Resin-based dentin bonding agent | Active comparator | Resin-based dentin bonding agent-Self etching adhesive Receives: Procedure: Indirect Pulp capping-Resin-based dentin bonding agent |
| Direct pulp capping therapy-Resin-modified calcium silicate - TheraCal | Active comparator | Resin modified calcium silicate-TheraCal (Light curable) Receives: Procedure: Direct Pulp capping-Resin-modified calcium silicate - TheraCal |
| Direct pulp capping therapy-Resin-modified calcium silicate - Calcium hydroxide - Dycal | Active comparator | - Calcium hydroxide - Dycal Receives: Procedure: Direct Pulp capping-Calcium hydroxide - Dycal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Deep Dental CariesStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Bedran-Russo, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635867
- Sponsor's protocol ID
- 2014-1163
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2015
- Last updated
- 12 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Vital Pulp Capping Restorative Protocols: A Randomized Controlled Double-Blind, Prospective Study
- ClinicalTrials.gov ID
- NCT02635867
- Acronym / sponsor ID
- 2014-1163
- Conditions
- Deep Dental Caries
- Keywords
- vital pulp, reversible pulpitis, pulp capping, deep cavity, Management of Deep Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Posted 12 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized, controlled, double-blind, prospective study compares over a period of 12 months, the post-operative sensitivity and pulp vitality of three indirect pulp capping protocols (TheraCal, Bisco; Dycal, Caulk, and no liner). The study was approved by the University of Illinois internal review board (Protocol # 2014-1163). Potential subjects will be screened by one of 3 calibrated investigators through a brief interview and intraoral examination. The screening process includes a medical and dental history, demographics, current/concomitant medication, oral soft and hard tissue examination, 2 radiographs: one periapical and one bitewing, and a review of all inclusion and exclusion criteria. The inclusion criteria consist of adults in good general health between 18 and 64 years of age; with primary active carious lesions deep into the dentin (75% or more of carious dentin) of permanent teeth; absence of clinical symptoms of irreversible pulpitis (spontaneous pain and lingering pain for more than 10 seconds after cold stimulus), and absence of periapical pathology, sinus tract, swelling or abnormal mobility. The outcomes measures are pain using visual analog pain scale (pain assessment form) and success rate (pulp vitality based on percussion, palpation, cold test, radiographic findings), collected at the screening visit, intervention day, 24 hours, 7 days, 3 months, 6 months, and 12 months follow-up visits,
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Indirect pulp capping therapy-Resin-modified calcium silicate - TheraCal | Active comparator | Procedure: Indirect Pulp capping-Resin-modified calcium silicate - TheraCalResin modified calcium silicate-TheraCal (light curable) |
| Indirect pulp capping therapy- - Calcium hydroxide - Dycal | Active comparator | Procedure: Indirect Pulp capping-Calcium hydroxide - DycalCalcium hydroxide - Dycal |
| Indirect pulp capping therapy-- Resin-based dentin bonding agent | Active comparator | Procedure: Indirect Pulp capping-Resin-based dentin bonding agentResin-based dentin bonding agent-Self etching adhesive |
| Direct pulp capping therapy-Resin-modified calcium silicate - TheraCal | Active comparator | Procedure: Direct Pulp capping-Resin-modified calcium silicate - TheraCalResin modified calcium silicate-TheraCal (Light curable) |
| Direct pulp capping therapy-Resin-modified calcium silicate - Calcium hydroxide - Dycal | Active comparator | Procedure: Direct Pulp capping-Calcium hydroxide - Dycal- Calcium hydroxide - Dycal |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- Non restorable teeth;
- Teeth with:
- Recent trauma (within 6 months);
- Calcified root canals;
- Periapical radiolucency;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indirect Pulp capping-Resin-modified calcium silicate - TheraCalUse of a dental restorative protocol using Resin-modified calcium silicate - TheraCal pulp capping restorative material | Procedure or surgery | Indirect pulp capping therapy-Resin-modified calcium silicate - TheraCal |
| Indirect Pulp capping-Calcium hydroxide - DycalUse of a dental restorative protocol using Calcium hydroxide - Dycal pulp capping restorative material | Procedure or surgery | Indirect pulp capping therapy- - Calcium hydroxide - Dycal |
| Indirect Pulp capping-Resin-based dentin bonding agentUse of a dental restorative protocol using resin-based dentin bonding system only | Procedure or surgery | Indirect pulp capping therapy-- Resin-based dentin bonding agent |
| Direct Pulp capping-Resin-modified calcium silicate - TheraCalUse of a dental restorative protocol using Resin-modified calcium silicate - TheraCal pulp capping restorative material | Procedure or surgery | Direct pulp capping therapy-Resin-modified calcium silicate - TheraCal |
| Direct Pulp capping-Calcium hydroxide - Dycal\Use of a dental restorative protocol using Calcium hydroxide - Dycal pulp capping restorative material | Procedure or surgery | Direct pulp capping therapy-Resin-modified calcium silicate - Calcium hydroxide - Dycal |
Primary outcome
Success Rate Based on Pulp Vitality Tests (Vital/Non Vital)
Time frame: 12 months
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).
Pain Assessment Using Visual Analog Pain Scale (VAS) Scale.
Time frame: 12 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect Pulp capping-Resin-modified calcium silicate - TheraCal, Indirect Pulp capping-Calcium hydroxide - Dycal and Indirect Pulp capping-Resin-based dentin bonding agent in people with Deep Dental Caries, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate Based on Pulp Vitality Tests (Vital/Non Vital) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.