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| Name | Class |
|---|---|
| Cairo University | OTHER |
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Aim of the study: To compare the clinical and radiographic outcomes of mineral trioxide aggregate (MTA) and Biodentine as vital pulp therapy materials (pulpotomy) of cariously exposed vital immature mandibular first permanent molars.
Materials and Methods: sixty immature first mandibular permanent molars cariously exposed with symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria and were equally divided in two groups. Following split-mouth design molars were randomly assigned to either a control group (MTA 30 molars) or a test group (Biodentine 30 molars). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine, treated molars received permanent restorations. Blinded clinical and radiographic evaluations were performed at different time intervals (base line immediate postoperative, 6, 12 and 18 months) according to clinical and radiographic criteria of success. Data were recorded and analysed.
Diagnosis:
Operative procedure:
Experimental group:
Control group:
The same procedures will be carried out as the experimental group, but the pulp stumps will be covered with fast-setting mineral trioxide aggregate (MTA) ENDOCEM MTA (Maruchi, Wonju, Korea) and will be prepared according to the manufacturer's instructions. A 3-mm-thick layer of MTA will be placed over the amputated pulps and will be gently adapted to the dentinal walls using a wet cotton pellet. A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan) will be placed over the pulpotomy agent as a final restoration.
Postoperative care:
Instructions to avoid lip and cheek biting in addition to oral hygiene measures.
Follow up:
Assess the outcomes clinically and radiographically at (baseline, 6, 12 and 18 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MTA Group | Active Comparator | pulpotomy technique using fast-setting mineral trioxide aggregate (MTA) to be considered the control group for vital pulp therapy and was placed over the amputated pulps for 18 months. This group will be compared with the Biodentine group as the intervention group |
|
| Biodentine group | Experimental | 3 mm- thick Biodentine covered radicular pulp to allow pulp regeneration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biodentine | Biological | it is a dentin substitute, a new biologically active material facilitates its penetration through opened dentinal tubules to crystallize interlocking with dentin and provide mechanical properties. |
| Measure | Description | Time Frame |
|---|---|---|
| pain, sensitivity to percussion⁄ palpation | by asking the patient( binary measure)Yes or No, where Yes indicates presence of pain that shows clinical failure | 18 months |
| Swelling or sinus tract | by visual examination( Binary measure) (Yes or No) where No indicates success of the treatment | 18 months |
| tooth mobility | by back of the mirror( Binary measure) (Yes or No) where No mobility indicates success of the treatment | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| root formation/development stage | by radiographic parallel technique to measure the maturity scores used during the radiographic assessment of root development are F, G and H (where F is the worse and H is the best stage) | 18 months |
| Crown: Root ratio |
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Inclusion Criteria:
Bilaterally Symptomatic ⁄ asymptomatic vital immature mandibular first permanent molars (with clinical carious exposure of the pulp and presence of bleeding upon exposure)
Exclusion Criteria:
• Molars were excluded if non-restorable.
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| Name | Affiliation | Role |
|---|---|---|
| Gihan M Abuelniel, PhD | Cairo University | Principal Investigator |
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only final results
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 1, 2019 | |
| Unrelease | Dec 3, 2019 | |
| Release | Dec 3, 2019 | |
| Reset | Dec 20, 2019 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2017 | Feb 7, 2019 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 1, 2019 | Dec 3, 2019 | |||
| Dec 3, 2019 |
| ID | Term |
|---|---|
| C506393 | tricalcium silicate |
| D000068437 | Pemetrexed |
| C086631 | mineral trioxide aggregate |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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|
| MTA | Biological | MTA is a powder that consists of fine hydrophilic particles that set in the presence of moisture. MTA consists of tricalcium silicate, tricalcium aluminate, tricalcium oxide and silicate oxide. MTA was considered a remarkable biocompatible material with various clinical applications that include surgical and non-surgical applications such as pulp capping |
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by radiographic parallel technique ( the ratio 2:1 or more than 2:1) the ratio more than 2:1 is the best |
| 18 months |
| Apical closure | by radiographic parallel technique( the apex is blunder apex ,partially open, or constricted) blunder apex is the worse and constricted apex is the best. | 18 months |
| presence of radiolucency | by radiographic parallel technique( binary measure)( yes or No) if radiolucency is detected this indicates failure of the treatment | 18 month |
| Dec 20, 2019 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |