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The process of dental caries is dynamic and can be either reversible or irreversible depending on the balance between protective and pathologic factors in the oral cavity. Untreated dental caries causes pulpal injury, inflammation, and necrosis. Melatonin plays an essential role in the regulation of bone growth. The actions that melatonin exerts on odontoblasts may be similar to its action on osteoblasts.
The aim of this study is to evaluate and compare the pulp response of young permanent first molars after apexogenesis procedure, using melatonin versus MTA clinically and radiographically. This study will be performed on 45 young permanent first molars that will be divided equally into three groups according to the material used following apexogenesis; GroupI: MTA, GroupII: Melatonin and GroupIII: MTA and Melatonin. apexogenesis procedures will be carried out in children aged 6 to 8 years old. This will be followed by placement of MTA or/and Melatonin material as a sub base in the pulp chamber according to the group. Then, placement of a conventional glass ionomer cement (FUGI IX) as a permanent restoration will be conducted. Then, an immediate postoperative periapical digital x-ray film will be taken for the patients. The patient follow-up will be assigned 1,3,6,9 and 12 months after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mineral Trioxide Aggregate | Active Comparator | is a powder that consist of Calcium oxide, silicone dioxide, aluminum oxide, bismuth oxide, purified water. It is a bactericidal dressing material, promotes pulp healing, and does so without producing inflammation and promotes dentin bridge formation. |
|
| Melatonin | Experimental | (N-acetyl-5-methoxy-tryptamine) is a pleiotropic hormone synthesized in the pineal gland that has important chronobiotic properties. there is a Melatonin drug (powder) that proved to play an essential role in the regulation of bone growth (bone regeneration) and it may promote osteoblast differentiation, and stimulates mineralized matrix formation |
|
| Mineral Trioxide and Melatonin | Experimental | Mixture of the two materials' powders. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mineral trioxide aggregate (dressing material) | Drug | MTA (Angulus Industrial de productus Odontologists S/a, Brazil) that applied on dental pulp for tissue regeneration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinically assessment (Modified visual analogue scale) | Pain, sensitivity to percussion (scale values from 0 to 10) 0 means no pain and 10 means the worst pain with failure of the treatment. | Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months |
| Clinically assessment (Millar's index) | tooth mobility (classes I,II,III) from less mobility to higher mobility. | Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months |
| Clinically assessment (presence or abscence) | changes in mucobuccal folds (swelling, redness, abscess,fistula) | Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months |
| Radiographic assessment (using Image J software program) | Density of calcific tissue (dentinal bridge) underneath MTA, Melatonin and their mixture (the 3 groups) (Densitometric analysis) | Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months |
| Radiographic assessment (using Image J software program) | Thickness of calcific tissue (dentinal bridge) underneath MTA, Melatonin and their mixture (the 3 groups) | Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months |
| Radiographic assessment (using Image J software program) | Width of apical foramina for the 3 groups. | Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mennatallah Hesham El shaabany, doctorate student | Contact | 01012906460 | 01005359111 | menna.hesham@dent.suez.edu.eg |
| Asmaa Ali Abo El-Soud, Associate professor | Contact | 01220989854 | asmaa_ali@dent.suez.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Gihan GED El-Desouky, Professor | Professor | Principal Investigator |
| Ghada AH Elbaz, Professor | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Suez canal university | Recruiting | Ismailia | 41522 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32041360 | Result | Guerrero-Girones J, Alcaina-Lorente A, Ortiz-Ruiz C, Ortiz-Ruiz E, Pecci-Lloret MP, Rodriguez-Lozano FJ, Martinez CM, Ortiz-Ruiz AJ. Melatonin as an Agent for Direct Pulp-Capping Treatment. Int J Environ Res Public Health. 2020 Feb 6;17(3):1043. doi: 10.3390/ijerph17031043. | |
| 28692829 | Result | Liu Q, Fan W, He Y, Zhang F, Guan X, Deng Q, Lu X, He H, Huang F. Effects of melatonin on the proliferation and differentiation of human dental pulp cells. Arch Oral Biol. 2017 Nov;83:33-39. doi: 10.1016/j.archoralbio.2017.06.034. Epub 2017 Jun 30. |
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|
| Melatonin (dressing material) | Drug | melatonin powder 250mg (sigma, Aldrich)- white powder mixing with saline and applied on dental pulp |
|
|
| Radiographic assessment (using Image J software program) | Linear radiographic measurement of root development. | Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months |
| Radiographic assessment (using Image J software program) | Assessment of changes in bone density surrounding the treated teeth (Densiometric analysis) | Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months |
| 33440268 | Result | Vaseenon S, Chattipakorn N, Chattipakorn SC. Effects of melatonin in wound healing of dental pulp and periodontium: Evidence from in vitro, in vivo and clinical studies. Arch Oral Biol. 2021 Mar;123:105037. doi: 10.1016/j.archoralbio.2020.105037. Epub 2021 Jan 6. |
| ID | Term |
|---|---|
| C086631 | mineral trioxide aggregate |
| D000068437 | Pemetrexed |
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | 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 |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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