Deep Caries
Conditions
Keywords
Theracal, formocresol, pulpotomy
Brief summary
Light cured silicate based cement (theracal LC) pulpotomy was compared to formocresol pulpotomy in primary molars.
Detailed description
sixty primary molars were either treated with Theracal LC or formocresol pulpotomy. Teeth were followed up clinicaly and radiographically for 12 months.
Interventions
DRUGTheracal LC
pulpotomy
DRUGFormocresol
Pulpotomy
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy, cooperative children * mandibular primary molars with vital pulp exposures
Exclusion criteria
* clinical or radiographic evidence of irreversible pulpitis * physiological root resorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Examination | 12 months | Number of participants with tooth mobility, restoration loss, gingival swelling/fistula, pain on percussion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Examination | 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. |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| Formocresol 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 | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Total | Theracal LC | Formocresol |
|---|---|---|---|
| Age, Categorical <=18 years | 60 Participants | 30 Participants | 30 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.61 years STANDARD_DEVIATION 0.55 | 5.71 years STANDARD_DEVIATION 0.59 | 5.56 years STANDARD_DEVIATION 0.71 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| radiographic and clinical examinations | 8 participants | 3 participants | 5 participants |
| Region of Enrollment Egypt | 60 Participants | 30 Participants | 30 Participants |
| Sex: Female, Male Female | 28 Participants | 13 Participants | 15 Participants |
| Sex: Female, Male Male | 32 Participants | 17 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 3 / 30 | 5 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Clinical Examination
Number of participants with tooth mobility, restoration loss, gingival swelling/fistula, pain on percussion.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Theracal LC | Clinical Examination | 30 Participants |
| Formocresol | Clinical Examination | 30 Participants |
Secondary
Radiographic Examination
Number of participants showing teeth with inter-radicular bone resorption, periapical bone resorption, internal root resorption, external root resorption, widening of periodontal ligament space.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Theracal LC | Radiographic Examination | 30 Participants |
| Formocresol | Radiographic Examination | 30 Participants |