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| ID | Type | Description | Link |
|---|---|---|---|
| SA13I20175 | Other Grant/Funding Number | FONIS SA13I20175 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mineral trioxide aggregate (MTA) | Experimental | Mineral trioxide aggregate Root canal repair material |
|
| Calcium hydroxide | Active Comparator | -material for pulp capping |
|
| Biodentine | Experimental | Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mineral trioxide aggregate | Drug | Mineral trioxide aggregate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parameters Evaluated After Treatment | vitality test with electric device cold and hot test radiographic evaluation | 3 months, 6 moths and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Effects | Name any adverse effects caused by treatment. | 1 week, 3 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Brizuela | Universidad de Los Andes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Salud de San Bernardo Universidad de Los Andes | Santiago | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20478462 | Background | Paranjpe A, Zhang H, Johnson JD. Effects of mineral trioxide aggregate on human dental pulp cells after pulp-capping procedures. J Endod. 2010 Jun;36(6):1042-7. doi: 10.1016/j.joen.2010.02.013. Epub 2010 Mar 15. | |
| 22251035 | Background | Leye Benoist F, Gaye Ndiaye F, Kane AW, Benoist HM, Farge P. Evaluation of mineral trioxide aggregate (MTA) versus calcium hydroxide cement (Dycal((R)) ) in the formation of a dentine bridge: a randomised controlled trial. Int Dent J. 2012 Feb;62(1):33-9. doi: 10.1111/j.1875-595X.2011.00084.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mineral Trioxide Aggregate (MTA) | Mineral trioxide aggregate Root canal repair material Mineral trioxide aggregate: Mineral trioxide aggregate |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mineral Trioxide Aggregate (MTA) | Mineral trioxide aggregate Root canal repair material Mineral trioxide aggregate: Mineral trioxide aggregate |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Parameters Evaluated After Treatment | vitality test with electric device cold and hot test radiographic evaluation | Intent a preventive treatment against cavities to avoid endodoncies with different treatments and see which one is more effective after 12 months follow up. | Posted | Count of Participants | Participants | 3 months, 6 moths and 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mineral Trioxide Aggregate (MTA) | Mineral trioxide aggregate Root canal repair material Mineral trioxide aggregate: Mineral trioxide aggregate |
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The small sample due to inclusion criteria. Lack of collaboration from the primary health providers. And the fact that the oral health seems not to be a priority and people only come when it hurts and it is too late for prevention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dra. CLAUDIA BRIZUELA CORDERO | UNIVERSIDAD DE LOS ANDES | 562226181166 | clau@cibrizuela.com |
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| ID | Term |
|---|---|
| D003789 | Dental Pulp Exposure |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C086631 | mineral trioxide aggregate |
| D002126 | Calcium Hydroxide |
| C506393 | tricalcium silicate |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017610 | Calcium Compounds |
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| Calcium hydroxide | Drug | Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material. |
|
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| Biodentine | Drug | Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution. |
|
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| 23683272 | Background | Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, Kosierkiewicz A, Kaczmarek W, Buczkowska-Radlinska J. Response of human dental pulp capped with biodentine and mineral trioxide aggregate. J Endod. 2013 Jun;39(6):743-7. doi: 10.1016/j.joen.2013.01.005. Epub 2013 Apr 10. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Tooth | Count of Participants | Participants |
|
| OG002 | 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. |
|
|
| Secondary | Number of Participants With Adverse Effects | Name any adverse effects caused by treatment. | Posted | Count of Participants | Participants | 1 week, 3 and 6 months |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | 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. | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D000838 |
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |