Clinical trial

Comparative Evaluation of Melatonin Versus Mineral Trioxide Aggregate on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study

Name
Melatonin- vital pulp therapy
Description
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.
Trial arms
Trial start
2023-05-20
Estimated PCD
2024-05-20
Trial end
2024-06-20
Status
Recruiting
Treatment
Mineral trioxide aggregate (dressing material)
MTA (Angulus Industrial de productus Odontologists S/a, Brazil) that applied on dental pulp for tissue regeneration
Arms:
Mineral Trioxide Aggregate, Mineral Trioxide and Melatonin
Other names:
MTA
Melatonin (dressing material)
melatonin powder 250mg (sigma, Aldrich)- white powder mixing with saline and applied on dental pulp
Arms:
Melatonin, Mineral Trioxide and Melatonin
Other names:
N-acetyl-5-methoxy-tryptamine
Size
45
Primary endpoint
Clinically assessment (Modified visual analogue scale)
Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
Clinically assessment (Millar's index)
Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
Clinically assessment (presence or abscence)
Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
Radiographic assessment (using Image J software program)
Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
Radiographic assessment (using Image J software program)
Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
Radiographic assessment (using Image J software program)
Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
Radiographic assessment (using Image J software program)
Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
Radiographic assessment (using Image J software program)
Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}
Updated at
2024-04-18

1 organization

2 products

2 indications

Indication
Pulpitis
Product
Melatonin