Evaluate the Effects of MEDCEM PC and MTA in Pulpotomies of Primary Molars. Clinical Trial
The objective of the study is to evaluate and compare, clinically and radiographically,the effects of MEDCEM PC and MTA when used as pulp dressings following pulpotomy in human primary molars.
| Status | Recruiting |
| Enrollment | 80 |
| Est. completion date | December 2016 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 3 Years to 10 Years |
| Eligibility |
Inclusion Criteria: - healthy children - molars showing: symptomless exposure of vital pulp by caries no clinical or radiographic evidence of pulp degeneration (excessive bleeding from the root canal, internal root resorption, inter-radicular and/or furcal bone destruction) the possibility of proper restoration of the teeth no physiological resorption of more than one-third of the root Exclusion Criteria: - presence of systemic pathology - history of allergic reaction to latex, local anaesthetics or to the constituents of the test pulp dressing agents |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Universitat Internacional de Catalunya | Sant Cugat del Valles | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Universitat Internacional de Catalunya |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical success | No pain, no swelling, no fistula or sinus tract, no pathologic mobility | 24 months | No |
| Primary | Radiographic success | No internal root resorption progressing into the bone, no external root resorption, no furcation and/or periapical bone destruction | 24 months | No |