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Clinical Comparison of Vital Pulp Capping Restorative Protocols

Clinical Comparison of Vital Pulp Capping Restorative Protocols: A Randomized Controlled Double-Blind, Prospective Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02635867
Enrollment
109
Registered
2015-12-21
Start date
2015-06-30
Completion date
2019-08-31
Last updated
2023-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Dental Caries

Keywords

vital pulp, reversible pulpitis, pulp capping, deep cavity, Management of Deep Dental Caries

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.

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,

Interventions

PROCEDUREIndirect Pulp capping-Resin-modified calcium silicate - TheraCal

Use of a dental restorative protocol using Resin-modified calcium silicate - TheraCal pulp capping restorative material

PROCEDUREIndirect Pulp capping-Calcium hydroxide - Dycal

Use of a dental restorative protocol using Calcium hydroxide - Dycal pulp capping restorative material

PROCEDUREIndirect Pulp capping-Resin-based dentin bonding agent

Use of a dental restorative protocol using resin-based dentin bonding system only

PROCEDUREDirect Pulp capping-Resin-modified calcium silicate - TheraCal

Use of a dental restorative protocol using Resin-modified calcium silicate - TheraCal pulp capping restorative material

PROCEDUREDirect Pulp capping-Calcium hydroxide - Dycal

\\Use of a dental restorative protocol using Calcium hydroxide - Dycal pulp capping restorative material

Sponsors

University of Illinois at Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Success Rate Based on Pulp Vitality Tests (Vital/Non Vital)12 monthsThe 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.12 monthsAll 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.

Countries

United States

Participant flow

Recruitment details

The study was designed to include teeth as participants. If an individual had multiple teeth that met the inclusion criteria, separate consents were signed and teeth were Enrolled. Recruitment was done at the University of Illinois College of Dentistry Comprehensive Adult clinics.

Participants by arm

ArmCount
Indirect Pulp Capping Therapy-Resin-modified Calcium Silicate - TheraCal
Indirect pulp capping therapy-Resin-modified calcium silicate liner - TheraCal (Bisco)
25
Indirect Pulp Capping Therapy-Resin-modified Calcium Silicate - TheraCal
Indirect pulp capping therapy-Resin-modified calcium silicate liner - TheraCal (Bisco)
30
Indirect Pulp Capping Therapy-Calcium Hydroxide - Dycal
Indirect pulp capping therapy- Calcium hydroxide - Dycal (Dentsply)
27
Indirect Pulp Capping Therapy-Calcium Hydroxide - Dycal
Indirect pulp capping therapy- Calcium hydroxide - Dycal (Dentsply)
30
Indirect Pulp Capping Therapy-Resin-based Dentin Bonding Agent
Indirect pulp capping therapy-Resin-based dentin bonding agent (All Bond)
27
Indirect Pulp Capping Therapy-Resin-based Dentin Bonding Agent
Indirect pulp capping therapy-Resin-based dentin bonding agent (All Bond)
30
Direct Pulp Capping Therapy-Resin-modified Calcium Silicate - TheraCal
Direct pulp capping therapy- Resin-modified calcium silicate liner - TheraCal (Bisco)
10
Direct Pulp Capping Therapy-Resin-modified Calcium Silicate - TheraCal
Direct pulp capping therapy- Resin-modified calcium silicate liner - TheraCal (Bisco)
10
Direct Pulp Capping Therapy-Calcium Hydroxide - Dycal
Direct pulp capping therapy: Calcium hydroxide - Dycal (Dentsply)
9
Direct Pulp Capping Therapy-Calcium Hydroxide - Dycal
Direct pulp capping therapy: Calcium hydroxide - Dycal (Dentsply)
9
Total207

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004
Overall StudyLost to Follow-up43341

Baseline characteristics

CharacteristicIndirect Pulp Capping Therapy-Calcium Hydroxide - DycalIndirect Pulp Capping Therapy-Resin-based Dentin Bonding AgentDirect Pulp Capping Therapy-Resin-modified Calcium Silicate - TheraCalIndirect Pulp Capping Therapy-Resin-modified Calcium Silicate - TheraCalDirect Pulp Capping Therapy-Calcium Hydroxide - DycalTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
27 Participants27 Participants10 Participants25 Participants9 Participants98 Participants
Age, Continuous39.2 years35 years39.8 years33.4 years34.9 years36.6 years
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants8 Participants1 Participants3 Participants2 Participants24 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants15 Participants9 Participants20 Participants7 Participants63 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants4 Participants0 Participants2 Participants0 Participants11 Participants
Pulp Diagnosis
Non vital
0 Teeth0 Teeth0 Teeth0 Teeth0 Teeth0 Teeth
Pulp Diagnosis
Vital
30 Teeth30 Teeth10 Teeth30 Teeth9 Teeth109 Teeth
Sex: Female, Male
Female
17 Participants17 Participants4 Participants16 Participants5 Participants59 Participants
Sex: Female, Male
Male
10 Participants10 Participants6 Participants9 Participants4 Participants39 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 300 / 300 / 100 / 9
other
Total, other adverse events
0 / 300 / 300 / 300 / 100 / 9
serious
Total, serious adverse events
0 / 300 / 300 / 300 / 100 / 9

Outcome results

Primary

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.

Time frame: 12 months

ArmMeasureValue (MEAN)
Indirect Pulp Capping Therapy-Theracal GroupPain Assessment Using Visual Analog Pain Scale (VAS) Scale.0 cm
Indirect Pulp Capping Therapy-Dycal GroupPain Assessment Using Visual Analog Pain Scale (VAS) Scale.0.7 cm
Indirect Pulp Capping- No Liner GroupPain Assessment Using Visual Analog Pain Scale (VAS) Scale.1.6 cm
Direct Pulp Capping- Theracal GroupPain Assessment Using Visual Analog Pain Scale (VAS) Scale.0 cm
Direct Pulp Capping-Dycal GroupPain Assessment Using Visual Analog Pain Scale (VAS) Scale.0 cm
Primary

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).

Time frame: 12 months

ArmMeasureValue (NUMBER)
Indirect Pulp Capping Therapy-Theracal GroupSuccess Rate Based on Pulp Vitality Tests (Vital/Non Vital)96.2 Percentage of success rate
Indirect Pulp Capping Therapy-Dycal GroupSuccess Rate Based on Pulp Vitality Tests (Vital/Non Vital)100 Percentage of success rate
Indirect Pulp Capping- No Liner GroupSuccess Rate Based on Pulp Vitality Tests (Vital/Non Vital)100 Percentage of success rate
Direct Pulp Capping- Theracal GroupSuccess Rate Based on Pulp Vitality Tests (Vital/Non Vital)86 Percentage of success rate
Direct Pulp Capping-Dycal GroupSuccess Rate Based on Pulp Vitality Tests (Vital/Non Vital)100 Percentage of success rate
Comparison: The clinical outcome measures assessed were pain using visual analog pain scale, pulp vitality assessment at 12 months.~The success rate was based on 3 measures of pulp vitality that resulted in a diagnosis of vital or nonvital:~Vital: palpation = negative/ percussion = negative/ response to cold stimuli= positive response Non vital: palpation = positive / percussion = positive. / response to cold stimuli= positive or delayed response time in seconds and lingering.p-value: >0.1Fisher Exact

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026