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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
MTA (Angulus Industrial de productus Odontologists S/a, Brazil) that applied on dental pulp for tissue regeneration
melatonin powder 250mg (sigma, Aldrich)- white powder mixing with saline and applied on dental pulp
Faculty of Medicine, Suez canal university
Ismailia, Egypt
RECRUITINGClinically 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
Radiographic assessment (using Image J software program)
Linear radiographic measurement of root development.
Time frame: 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)
Time frame: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
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