Trial Outcomes & Findings for Pulp Capping With Two Different Agents (NCT NCT00812877)

Results Overview

No recommendation for tooth extraction or root canal therapy. Only one tooth was enrolled/assessed per participant.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

376 participants

Primary outcome timeframe

Up to two years

Results posted on

2015-05-25

Participant Flow

Thirty-five dental practices recruited and enrolled subjects between May 2009 and March 2011.

Randomization was done on a practice level rather than a patient level. The handling characteristics of the two materials were so dissimilar that it was not feasible to blind the practitioners as to which material they were using.

Participant milestones

Participant milestones
Measure	Mineral Trioxide Aggregate Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap	Calcium Hydroxide Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
Overall Study STARTED	195	181
Overall Study COMPLETED	158	130
Overall Study NOT COMPLETED	37	51

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pulp Capping With Two Different Agents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mineral Trioxide Aggregate n=195 Participants Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap	Calcium Hydroxide n=181 Participants Pulp capping agent, Calcium Hydroxide used as a direct pulp cap	Total n=376 Participants Total of all reporting groups
Age, Categorical <=18 years	34 Participants n=5 Participants	31 Participants n=7 Participants	65 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	147 Participants n=5 Participants	138 Participants n=7 Participants	285 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Age, Continuous	38.5 years STANDARD_DEVIATION 18.6 • n=5 Participants	36.3 years STANDARD_DEVIATION 18.0 • n=7 Participants	37.5 years STANDARD_DEVIATION 18.3 • n=5 Participants
Sex: Female, Male Female	97 Participants n=5 Participants	94 Participants n=7 Participants	191 Participants n=5 Participants
Sex: Female, Male Male	98 Participants n=5 Participants	87 Participants n=7 Participants	185 Participants n=5 Participants
Region of Enrollment United States	195 participants n=5 Participants	181 participants n=7 Participants	376 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to two years

Population: 12 subjects were excluded in the Mineral Trioxide Aggregate group due to lack of follow-up (4 subjects were non-responsive; unable to contact 6 subjects; 2 subjects changed dentists) and 6 subjects were in the Calcium Hydroxide group (2 subjects were non-responsive; unable to contact 3 subjects; 1 subject was incarcerated).

No recommendation for tooth extraction or root canal therapy. Only one tooth was enrolled/assessed per participant.

Outcome measures

Outcome measures
Measure	Mineral Trioxide Aggregate n=183 Participants Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap	Calcium Hydroxide n=175 Participants Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
Tooth Survival	158 participants	130 participants

SECONDARY outcome

Timeframe: Up to two years

No evidence of pulpal resorption or calcification or periradicular radiolucency

Outcome measures

Outcome measures
Measure	Mineral Trioxide Aggregate n=183 Participants Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap	Calcium Hydroxide n=175 Participants Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
Pulp Vitality	155 participants	130 participants

Adverse Events

Mineral Trioxide Aggregate

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Calcium Hydroxide

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mineral Trioxide Aggregate n=195 participants at risk Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap	Calcium Hydroxide n=181 participants at risk Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death of patient	0.51% 1/195 • Number of events 1	0.00% 0/181
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death of Patient	0.51% 1/195 • Number of events 1	0.00% 0/181
Respiratory, thoracic and mediastinal disorders Death of patient	0.00% 0/195	0.55% 1/181 • Number of events 1

Other adverse events

Other adverse events
Measure	Mineral Trioxide Aggregate n=195 participants at risk Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap	Calcium Hydroxide n=181 participants at risk Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
General disorders Not feeling well	0.51% 1/195 • Number of events 1	0.00% 0/181
Gastrointestinal disorders H1N1 flu	0.51% 1/195 • Number of events 1	0.00% 0/181
Infections and infestations Toothache on non-study tooth	1.5% 3/195 • Number of events 3	0.00% 0/181
Infections and infestations Temperature sensitivity and dull ache in upper left quadrant	0.00% 0/195	0.55% 1/181 • Number of events 1
Metabolism and nutrition disorders Diabetes	0.00% 0/195	0.55% 1/181 • Number of events 1

Additional Information

Dr. Thomas J. Hilton

Oregon Health & Science University

Phone: 503.494.8672

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place