Clinical trial

Controlled Clinical Trial of the Effect of Calcium Hydroxide, Mineral Trioxide Aggregate (MTA) and Biodentine (Trademark) as Direct Pulp Capping Materials of Permanent Teeth Affected by Caries, in Children From 7 to 16 Years

Name
RPD-7-16
Description
Background: Dental caries is considered an oral health problem worldwide. In Chile the last national epidemiological study (2007) showed a national prevalence of dental caries in children 6 years (70.3%) and 12 (62.5%). Direct pulp capping is a preventive dental therapy, keeps the vitality of the tooth using some inductive materials mineralized tissue formation. Objective: The main objective of this study is to evaluate the effectiveness of two innovative direct pulp capping materials; Biodentine compared MTA and calcium hydroxide in the maintenance of pulp vitality in teeth permanent molars.
Trial arms
Trial start
2014-04-01
Estimated PCD
2016-04-01
Trial end
2016-08-01
Status
Completed
Phase
Early phase I
Treatment
Mineral trioxide aggregate
Mineral trioxide aggregate
Arms:
Mineral trioxide aggregate (MTA)
Other names:
MTA Pro Root
Calcium hydroxide
Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.
Arms:
Calcium hydroxide
Other names:
Calcium hydroxide Hertz
Biodentine
Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.
Arms:
Biodentine
Other names:
Active biosilicate. Septodont.
Size
169
Primary endpoint
Parameters Evaluated After Treatment
3 months, 6 moths and 12 months
Eligibility criteria
Inclusion Criteria: * Systemically healthy patients * Patients with at least one full or partial tooth root development * Clinical examination of the tooth must be selected diagnostic tests that are consistent with reversible pulpitis * Radiographic examination should show images of normal tissues without signs of internal resorption, the remaining healthy coronary should be sufficient for an indication of direct restoration * Teeth that have pulp exposure not exceeding 1 mm in size. Exclusion Criteria: * Every child with systemic and / or neurological conditions that make it impossible to focus on conventional dental clinic * Teeth uncontrolled excessive bleeding during communication pulp those aiming or have plans to move during that time period of 8 months .
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 169, 'type': 'ACTUAL'}}
Updated at
2024-05-30

1 organization

3 products

2 indications

Indication
Dental Caries
Indication
Pulpitis
Product
Biodentine