Comparative Evaluation of Melatonin Versus MTA on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-8
SponsorSuez Canal University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Internal root resorption.
External root resorption.
Inter radicular or periapical bone destruction (radiolucency)
A deep carious lesion radiologically that approaches the pulp
Trial design
Design model
Parallel
Treatments tested in this trial
Mineral trioxide aggregate (dressing material)
DrugMTA (Angulus Industrial de productus Odontologists S/a, Brazil) that applied on dental pulp for tissue regeneration
Melatonin (dressing material)
Drugmelatonin powder 250mg (sigma, Aldrich)- white powder mixing with saline and applied on dental pulp
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Mineral Trioxide AggregateActive comparator 1 intervention
Group B: MelatoninExperimental treatment 1 intervention
Group C: Mineral Trioxide and MelatoninExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov