Caries, Dental Pulp Exposure
Conditions
Keywords
dentin substitute, vital pulp therapy, Biodentine, caries
Brief summary
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.
Detailed description
Methodology: It is a randomized controlled study. groups signed the informed consent for clinical trial patients, a clinical evaluation of 90 permanent molars teeth through endodontic diagnostic tests and radiograph. will be conducted to determine diagnosis. Will be assigned randomly to the type of material to use and direct pulp teeth affected by caries coating is carried out; Patients will not have knowledge of the material to be used in the coating. The patient will be clinically evaluated at 1 week, 3 months and 8 months, and radiographically; at the beginning and end of the study. In each clinical control endodontic diagnostic tests of heat, cold, electric and percussion will be performed. In radiographic controls take a radiograph control with positioner or surveyor at baseline and 8 months, to evaluate the periapical status. Clinical success will consider that tooth in continuous controls and after 8 months presented vitality and radiographic signs of apical image without injury. Failure unresponsive to consider whether susceptibility testing of cold and electricity in more than one control and presents radiographic image with apical lesion.
Interventions
DRUGMineral trioxide aggregate
Mineral trioxide aggregate
DRUGCalcium hydroxide
Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.
DRUGBiodentine
Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.
Sponsors
Universidad de los Andes, Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 16 Years
Healthy volunteers
Yes
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parameters Evaluated After Treatment | 3 months, 6 moths and 12 months | vitality test with electric device cold and hot test radiographic evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Effects | 1 week, 3 and 6 months | Name any adverse effects caused by treatment. |
Countries
Chile
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mineral Trioxide Aggregate (MTA) Mineral trioxide aggregate Root canal repair material
Mineral trioxide aggregate: Mineral trioxide aggregate | 56 |
| Calcium Hydroxide -material for pulp capping
Calcium hydroxide: Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material. | 53 |
| Biodentine Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping
Biodentine: Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution. | 60 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 34 | 31 | 35 |
Baseline characteristics
| Characteristic | Mineral Trioxide Aggregate (MTA) | Calcium Hydroxide | Biodentine | Total |
|---|---|---|---|---|
| Age, Continuous | 11.51 years STANDARD_DEVIATION 2.34 | 11.64 years STANDARD_DEVIATION 2.65 | 11.22 years STANDARD_DEVIATION 2.34 | 11.44 years STANDARD_DEVIATION 2.44 |
| Sex: Female, Male Female | 29 Participants | 29 Participants | 29 Participants | 87 Participants |
| Sex: Female, Male Male | 27 Participants | 24 Participants | 31 Participants | 82 Participants |
| Tooth Mandibular First molar | 32 Participants | 36 Participants | 36 Participants | 104 Participants |
| Tooth Mandibular Second molar | 7 Participants | 6 Participants | 6 Participants | 19 Participants |
| Tooth Maxillary First molar | 16 Participants | 11 Participants | 17 Participants | 44 Participants |
| Tooth Maxillary Second molar | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 | 0 / 25 |
| other Total, other adverse events | 0 / 22 | 0 / 22 | 0 / 25 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 25 |
Outcome results
Primary
Parameters Evaluated After Treatment
vitality test with electric device cold and hot test radiographic evaluation
Time frame: 3 months, 6 moths and 12 months
Population: Intent a preventive treatment against cavities to avoid endodoncies with different treatments and see which one is more effective after 12 months follow up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mineral Trioxide Aggregate (MTA) | Parameters Evaluated After Treatment | Succesfull treatment | 19 Participants |
| Mineral Trioxide Aggregate (MTA) | Parameters Evaluated After Treatment | Need other treatment | 3 Participants |
| Calcium Hydroxide | Parameters Evaluated After Treatment | Succesfull treatment | 19 Participants |
| Calcium Hydroxide | Parameters Evaluated After Treatment | Need other treatment | 3 Participants |
| Biodentine | Parameters Evaluated After Treatment | Succesfull treatment | 25 Participants |
| Biodentine | Parameters Evaluated After Treatment | Need other treatment | 0 Participants |
Secondary
Number of Participants With Adverse Effects
Name any adverse effects caused by treatment.
Time frame: 1 week, 3 and 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mineral Trioxide Aggregate (MTA) | Number of Participants With Adverse Effects | 0 Participants |
| Calcium Hydroxide | Number of Participants With Adverse Effects | 0 Participants |
| Biodentine | Number of Participants With Adverse Effects | 0 Participants |