Trial Outcomes & Findings for Theracal Pulpotomy in Primary Molars (NCT NCT04397094)

NCT ID: NCT04397094

Last Updated: 2020-07-29

Results Overview

Number of participants with tooth mobility, restoration loss, gingival swelling/fistula, pain on percussion.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2020-07-29

Participant Flow

Participant milestones

Measure	Theracal LC Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Theracal LC: pulpotomy	Formocresol Formocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Formocresol: Pulpotomy
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Theracal LC n=30 Participants Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Theracal LC: pulpotomy	Formocresol n=30 Participants Formocresol (1/5 th concentration) was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Formocresol: Pulpotomy	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	30 Participants n=30 Participants	30 Participants n=30 Participants	60 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Continuous	5.71 years STANDARD_DEVIATION 0.59 • n=30 Participants	5.56 years STANDARD_DEVIATION 0.71 • n=30 Participants	5.61 years STANDARD_DEVIATION 0.55 • n=60 Participants
Sex: Female, Male Female	13 Participants n=30 Participants	15 Participants n=30 Participants	28 Participants n=60 Participants
Sex: Female, Male Male	17 Participants n=30 Participants	15 Participants n=30 Participants	32 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Egypt	30 Participants n=30 Participants	30 Participants n=30 Participants	60 Participants n=60 Participants
radiographic and clinical examinations	3 participants n=30 Participants	5 participants n=30 Participants	8 participants n=60 Participants

PRIMARY outcome

Timeframe: 12 months

Number of participants with tooth mobility, restoration loss, gingival swelling/fistula, pain on percussion.

Outcome measures

Measure	Theracal LC n=30 Participants Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Theracal LC: pulpotomy NO clinical failures was evident over the 12 months follow up	Formocresol n=30 Participants Formocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Formocresol: Pulpotomy NO clinical failures was evident over the 12 months follow up
Clinical Examination	30 Participants	30 Participants

SECONDARY outcome

Timeframe: 12 months

Number of participants showing teeth with inter-radicular bone resorption, periapical bone resorption, internal root resorption, external root resorption, widening of periodontal ligament space.

Outcome measures

Measure	Theracal LC n=30 Participants Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Theracal LC: pulpotomy NO clinical failures was evident over the 12 months follow up	Formocresol n=30 Participants Formocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Formocresol: Pulpotomy NO clinical failures was evident over the 12 months follow up
Radiographic Examination	30 Participants	30 Participants

Adverse Events

Theracal LC

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Formocresol

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Theracal LC n=30 participants at risk Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Theracal LC: pulpotomy	Formocresol n=30 participants at risk Formocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months. Formocresol: Pulpotomy
Musculoskeletal and connective tissue disorders internal resorption	6.7% 2/30 • Number of events 2 • 12 months	10.0% 3/30 • Number of events 3 • 12 months
Musculoskeletal and connective tissue disorders interradicular bone resorption	3.3% 1/30 • Number of events 1 • 12 months	6.7% 2/30 • Number of events 2 • 12 months

Additional Information

Dr. Mariem Wassel

Faculty of Dentistry Ain Shams University

Phone: +2 0064871416

Email: mariem.wassel@dent.asu.edu.eg

Results disclosure agreements

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