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Trial Outcomes & Findings for Comparison of Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies (NCT NCT02783911)

NCT ID: NCT02783911

Last Updated: 2021-06-11

Results Overview

At recall visits 6,9,12 months, blinded clinical examination will be completed by participating faculty members who are calibrated to clinical scaring criteria. Periapical radiographs will be taken and evaluated by 2 pediatric dentists and 1 endodontist, for presence of various pathologies. Scored based on the criteria established by Zurn and Seale 2008. Scores will be transferred to Microsoft Excel. The difference between the two materials will be analyzed using the Mann-Whiteney U test, chi-square test and Fisher's exact test. Intra- and inter-rater agreement will be measured for radiographic assessment using Cohen's kappa test

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

57 participants

Primary outcome timeframe

1 year

Results posted on

2021-06-11

Participant Flow

3-10 years old, deep caries, No radiographic signs of internal/external root resorption, No pathology change, no swelling or abscess.

Unit of analysis: tooth

Participant milestones

Participant milestones
Measure
Mineral Trioxide Aggregate
Subject with pulpotomy treated with MTA MTA paste (\< 1gm) will be placed on pulp orifice once for the life of the primary teeth MTA: Mineral Trioxide Aggregate grey paste
Ferric Sulfate
Subject with pulpotomy treated with FS FS paste (\<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth Ferric Sulfate: Ferric Sulfate paste
Overall Study
STARTED
11 12
46 53
Overall Study
COMPLETED
8 9
14 15
Overall Study
NOT COMPLETED
3 3
32 38

Reasons for withdrawal

Reasons for withdrawal
Measure
Mineral Trioxide Aggregate
Subject with pulpotomy treated with MTA MTA paste (\< 1gm) will be placed on pulp orifice once for the life of the primary teeth MTA: Mineral Trioxide Aggregate grey paste
Ferric Sulfate
Subject with pulpotomy treated with FS FS paste (\<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth Ferric Sulfate: Ferric Sulfate paste
Overall Study
Lost to Follow-up
3
32

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Mineral Trioxide Aggregate
n=11 Participants
Subject with pulpotomy treated with MTA MTA paste (\< 1gm) will be placed on pulp orifice once for the life of the primary teeth MTA: Mineral Trioxide Aggregate grey paste
Ferric Sulfate
n=46 Participants
Subject with pulpotomy treated with FS FS paste (\<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth Ferric Sulfate: Ferric Sulfate paste
Total
n=57 Participants
Total of all reporting groups
Age, Categorical
<=18 years
11 Participants
n=11 Participants
46 Participants
n=46 Participants
57 Participants
n=57 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=11 Participants
0 Participants
n=46 Participants
0 Participants
n=57 Participants
Age, Categorical
>=65 years
0 Participants
n=11 Participants
0 Participants
n=46 Participants
0 Participants
n=57 Participants
Age, Continuous
73.9 Months
STANDARD_DEVIATION 16.9 • n=11 Participants
81.3 Months
STANDARD_DEVIATION 19.9 • n=46 Participants
78.5 Months
STANDARD_DEVIATION 18.8 • n=57 Participants
Sex: Female, Male
Female
8 Participants
n=11 Participants
17 Participants
n=46 Participants
25 Participants
n=57 Participants
Sex: Female, Male
Male
3 Participants
n=11 Participants
29 Participants
n=46 Participants
32 Participants
n=57 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
patient has deep caries
11 Participants
n=11 Participants
46 Participants
n=46 Participants
57 Participants
n=57 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The patients who came back for follow up for long term clinical and radiographic success.

At recall visits 6,9,12 months, blinded clinical examination will be completed by participating faculty members who are calibrated to clinical scaring criteria. Periapical radiographs will be taken and evaluated by 2 pediatric dentists and 1 endodontist, for presence of various pathologies. Scored based on the criteria established by Zurn and Seale 2008. Scores will be transferred to Microsoft Excel. The difference between the two materials will be analyzed using the Mann-Whiteney U test, chi-square test and Fisher's exact test. Intra- and inter-rater agreement will be measured for radiographic assessment using Cohen's kappa test

Outcome measures

Outcome measures
Measure
Mineral Trioxide Aggregate
n=9 tooth
Subject with pulpotomy treated with MTA MTA paste (\< 1gm) will be placed on pulp orifice once for the life of the primary teeth MTA: Mineral Trioxide Aggregate grey paste
Ferric Sulfate
n=15 tooth
Subject with pulpotomy treated with FS FS paste (\<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth Ferric Sulfate: Ferric Sulfate paste
Comparison of the Clinical Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies in Primary Molars
Clinical success
7 tooth
11 tooth
Comparison of the Clinical Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies in Primary Molars
Clinical fail
2 tooth
4 tooth

Adverse Events

Mineral Trioxide Aggregate

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ferric Sulfate

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

Dr. Jung-Wei Chen, Program director

LomaLindaU

Phone: 9095584690

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place