Trial Outcomes & Findings for MTA/FS Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial (NCT NCT02019563)

Results Overview

Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

70 participants

Primary outcome timeframe

12 months after the procedure

Results posted on

2016-02-11

Participant Flow

Subjects were recruited at The Hospital for Sick Children between September 2010 and September 2012.

Participant milestones

Participant milestones
Measure	MTA/FS Pulpotomy Group Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS). Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface.	RCT Group Children randomized to this group will undergo the root canal therapy (RCT) technique. Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE.
Overall Study STARTED	40	30
Overall Study COMPLETED	40	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MTA/FS Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MTA/FS Pulpotomy Group n=40 Participants Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS). Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface.	RCT Group n=30 Participants Children randomized to this group will undergo the root canal therapy (RCT) technique. Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE.	Total n=70 Participants Total of all reporting groups
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical <=18 years	40 Participants n=5 Participants	30 Participants n=7 Participants	70 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	16 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment Canada	40 participants n=5 Participants	30 participants n=7 Participants	70 participants n=5 Participants
Incisors	100 incisors n=5 Participants	72 incisors n=7 Participants	172 incisors n=5 Participants

PRIMARY outcome

Timeframe: 12 months after the procedure

Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.

Outcome measures

Outcome measures
Measure	MTA/FS Pulpotomy Group n=100 Incisors Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS). Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface.	RCT Group n=72 Incisors Children randomized to this group will undergo the root canal therapy (RCT) technique. Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE.
Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-procedure.	.97 Proportion of incisors	.92 Proportion of incisors

PRIMARY outcome

Timeframe: 18 months after the procedure

Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.

Outcome measures

Outcome measures
Measure	MTA/FS Pulpotomy Group n=100 Incisors Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS). Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface.	RCT Group n=72 Incisors Children randomized to this group will undergo the root canal therapy (RCT) technique. Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE.
Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcomes 18 Months Post-procedure.	.93 Proportion of incisors	.92 Proportion of incisors

SECONDARY outcome

Timeframe: 12 months after the procedure

Pulp treated incisors presenting with spontaneous pain, tenderness to percussion, fistula/sinus tract, soft tissue swelling and/or pathological tooth mobility were considered unacceptable clinical outcomes. Clinical outcomes between the MTA/FS pulpotomy and RCT groups were compared using Fisher's Exact test.

Outcome measures

Outcome measures
Measure	MTA/FS Pulpotomy Group n=100 Incisors Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS). Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface.	RCT Group n=72 Incisors Children randomized to this group will undergo the root canal therapy (RCT) technique. Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE.
Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 12 Months Post-procedure.	.98 Proportion of incisors	1.0 Proportion of incisors

SECONDARY outcome

Timeframe: 18 months after the procedure

Pulp treated incisors presenting with spontaneous pain, tenderness to percussion, fistula/sinus tract, soft tissue swelling and/or pathological tooth mobility were considered unacceptable clinical outcomes.

Outcome measures

Outcome measures
Measure	MTA/FS Pulpotomy Group n=100 Incisors Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS). Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface.	RCT Group n=72 Incisors Children randomized to this group will undergo the root canal therapy (RCT) technique. Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE.
Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 18 Months Post-procedure.	.97 Proportion of incisors	.98 Proportion of incisors

SECONDARY outcome

Timeframe: 12 and 18 months

Population: Four participants in the MTA/FS and two participants in the RCT group did not have data collected due to lost to follow-up. Remaining participants were censored if lost to follow-up, exfoliated, lost to trauma or had a non-occurrence of a failure before the trial end.

Kaplan-Meier survival curves were generated for the MTA/FS pulpotomy and RCT treatment groups. One treated incisor was selected by random draw from each subject for survival analysis to preserve independence of observations. The log-rank test was used to statistically compare survival of incisors.

Outcome measures

Outcome measures
Measure	MTA/FS Pulpotomy Group n=36 Participants Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS). Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface.	RCT Group n=28 Participants Children randomized to this group will undergo the root canal therapy (RCT) technique. Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE.
MTA/FS Pulpotomy and RCT Treated Incisor Survival Survival at 12 months	1 Proportion of participants	.97 Proportion of participants
MTA/FS Pulpotomy and RCT Treated Incisor Survival Survival at 18 months	.94 Proportion of participants	.97 Proportion of participants

Adverse Events

MTA/FS Pulpotomy Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

RCT Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Trang Nguyen

The Hospital for Sick Children

Phone: 6473300825

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place