Dental Caries in Children, Vital Pulp Therapy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGMineral trioxide aggregate (dressing material)
MTA (Angulus Industrial de productus Odontologists S/a, Brazil) that applied on dental pulp for tissue regeneration
DRUGMelatonin (dressing material)
melatonin powder 250mg (sigma, Aldrich)- white powder mixing with saline and applied on dental pulp
Sponsors
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* 1- Apparently healthy and medically free children. 2- Their age ranges from 6-8 years. 3- Both boys and girls will be included. 4- Children should have mandibular permanent first molars with the following clinical and radiographic criteria. 4.1Restorable young permanent first molars. 4.2Absence of clinical evidence of pulp degeneration: * No history of spontaneous pain, history of night pain or pain that not relieved by analgesics. * No pain on percussion. * No mobility. * Absence of abscess, purulent sinus or soft tissue edema. * Bleeding should stop within 5 minutes after the amputated pulp stumps.
Exclusion criteria
* Internal root resorption. * External root resorption. * Inter radicular or periapical bone destruction (radiolucency) * A deep carious lesion radiologically that approaches the pulp
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically assessment (Modified visual analogue scale) | Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months | 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. |
| Clinically assessment (Millar's index) | Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months | tooth mobility (classes I,II,III) from less mobility to higher mobility. |
| Clinically assessment (presence or abscence) | Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months | changes in mucobuccal folds (swelling, redness, abscess,fistula) |
| Radiographic assessment (using Image J software program) | Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months | Density of calcific tissue (dentinal bridge) underneath MTA, Melatonin and their mixture (the 3 groups) (Densitometric analysis) |
Countries
Egypt
Contacts
Primary ContactMennatallah Hesham El shaabany, doctorate student
Backup ContactAsmaa Ali Abo El-Soud, Associate professor
Outcome results
None listed