Trial Outcomes & Findings for Clinical Comparison of Vital Pulp Capping Restorative Protocols (NCT NCT02635867)

Last Updated: 2023-10-12

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

109 participants

Primary outcome timeframe

12 months

Results posted on

2023-10-12

Participant Flow

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.

Unit of analysis: teeth

Participant milestones

Participant milestones
Measure	Indirect Pulp Capping Therapy-Theracal LC Group A: Resin-modified calcium silicate - TheraCal LC (Bisco)	Indirect Pulp Capping Therapy: Calcium Hydroxide - Dycal Indirect pulp capping therapy-Group B-Calcium hydroxide - Dycal (Dentsply)	Indirect Pulp Capping-Resin-based Dentin Bonding Agent Group C: Resin-based dentin bonding agent (All Bond Universal system)	Direct Pulp Capping Therapy-Theracal LC Group A: Resin-modified calcium silicate..	Direct Pulp Capping Therapy: Calcium Hydroxide-Dycal Direct pulp capping therapy: Calcium hydroxide - Dycal
Overall Study STARTED	25 30	27 30	27 30	10 10	9 9
Overall Study COMPLETED	21 25	24 27	24 27	6 6	8 8
Overall Study NOT COMPLETED	4 5	3 3	3 3	4 4	1 1

Reasons for withdrawal

Reasons for withdrawal
Measure	Indirect Pulp Capping Therapy-Theracal LC Group A: Resin-modified calcium silicate - TheraCal LC (Bisco)	Indirect Pulp Capping Therapy: Calcium Hydroxide - Dycal Indirect pulp capping therapy-Group B-Calcium hydroxide - Dycal (Dentsply)	Indirect Pulp Capping-Resin-based Dentin Bonding Agent Group C: Resin-based dentin bonding agent (All Bond Universal system)	Direct Pulp Capping Therapy-Theracal LC Group A: Resin-modified calcium silicate..	Direct Pulp Capping Therapy: Calcium Hydroxide-Dycal Direct pulp capping therapy: Calcium hydroxide - Dycal
Overall Study Lost to Follow-up	4	3	3	4	1

Baseline Characteristics

Clinical outcome criteria: Pulpal diagnosis: Vital pulp/Nonvital. 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).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Indirect Pulp Capping Therapy-Resin-modified Calcium Silicate - TheraCal n=30 Teeth Indirect pulp capping therapy-Resin-modified calcium silicate liner - TheraCal (Bisco)	Indirect Pulp Capping Therapy-Calcium Hydroxide - Dycal n=30 Teeth Indirect pulp capping therapy- Calcium hydroxide - Dycal (Dentsply)	Indirect Pulp Capping Therapy-Resin-based Dentin Bonding Agent n=30 Teeth Indirect pulp capping therapy-Resin-based dentin bonding agent (All Bond)	Direct Pulp Capping Therapy-Resin-modified Calcium Silicate - TheraCal n=10 Teeth Direct pulp capping therapy- Resin-modified calcium silicate liner - TheraCal (Bisco)	Direct Pulp Capping Therapy-Calcium Hydroxide - Dycal n=9 Teeth Direct pulp capping therapy: Calcium hydroxide - Dycal (Dentsply)	Total n=109 Teeth Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	27 Participants n=7 Participants	27 Participants n=5 Participants	10 Participants n=4 Participants	9 Participants n=21 Participants	98 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Continuous	33.4 years n=5 Participants	39.2 years n=7 Participants	35 years n=5 Participants	39.8 years n=4 Participants	34.9 years n=21 Participants	36.6 years n=10 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	17 Participants n=7 Participants	17 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	59 Participants n=10 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	39 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	24 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants	9 Participants n=4 Participants	7 Participants n=21 Participants	63 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	11 Participants n=10 Participants
Pulp Diagnosis Vital	30 Teeth n=5983 Teeth • Clinical outcome criteria: Pulpal diagnosis: Vital pulp/Nonvital. 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).	30 Teeth n=13 Teeth • Clinical outcome criteria: Pulpal diagnosis: Vital pulp/Nonvital. 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).	30 Teeth n=13 Teeth • Clinical outcome criteria: Pulpal diagnosis: Vital pulp/Nonvital. 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).	10 Teeth n=39 Teeth • Clinical outcome criteria: Pulpal diagnosis: Vital pulp/Nonvital. 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).	9 Teeth n=9 Teeth • Clinical outcome criteria: Pulpal diagnosis: Vital pulp/Nonvital. 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).	109 Teeth n=109 Teeth • Clinical outcome criteria: Pulpal diagnosis: Vital pulp/Nonvital. 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).
Pulp Diagnosis Non vital	0 Teeth n=5983 Teeth • Clinical outcome criteria: Pulpal diagnosis: Vital pulp/Nonvital. 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).	0 Teeth n=13 Teeth • Clinical outcome criteria: Pulpal diagnosis: Vital pulp/Nonvital. 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).	0 Teeth n=13 Teeth • Clinical outcome criteria: Pulpal diagnosis: Vital pulp/Nonvital. 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).	0 Teeth n=39 Teeth • Clinical outcome criteria: Pulpal diagnosis: Vital pulp/Nonvital. 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).	0 Teeth n=9 Teeth • Clinical outcome criteria: Pulpal diagnosis: Vital pulp/Nonvital. 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).	0 Teeth n=109 Teeth • Clinical outcome criteria: Pulpal diagnosis: Vital pulp/Nonvital. 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).

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Indirect Pulp Capping Therapy-Theracal Group n=25 Teeth Application of resin-modified calcium silicate (TheraCal LC - Bisco) pulp capping material	Indirect Pulp Capping Therapy-Dycal Group n=27 Teeth Application of calcium hydroxide cement (Dycal - Dentsply) pulp capping material	Indirect Pulp Capping- No Liner Group n=27 Teeth Use of dentin bonding system only. All Bond Universal self-etching system (Bisco)	Direct Pulp Capping- Theracal Group n=6 Teeth Application of resin-modified calcium silicate (TheraCal LC - Bisco) pulp capping material	Direct Pulp Capping-Dycal Group n=8 Teeth Application of calcium hydroxide cement (Dycal - Dentsply) pulp capping material
Success Rate Based on Pulp Vitality Tests (Vital/Non Vital)	96.2 Percentage of success rate	100 Percentage of success rate	100 Percentage of success rate	86 Percentage of success rate	100 Percentage of success rate

PRIMARY outcome

Timeframe: 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.