Comparative Evaluation of Melatonin Versus MTA on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mineral trioxide aggregate (dressing material), Melatonin (dressing material).
- Who it may be relevant to
- Registry conditions: Dental Caries in Children, Vital Pulp Therapy. Basic parameters: 6 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Evaluation of Melatonin Versus Mineral Trioxide Aggregate on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study
Overview
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
- Drug Mineral trioxide aggregate (dressing material)
MTA (Angulus Industrial de productus Odontologists S/a, Brazil) that applied on dental pulp for tissue regeneration - Drug Melatonin (dressing material)
melatonin powder 250mg (sigma, Aldrich)- white powder mixing with saline and applied on dental pulp
Primary outcome measures
- Clinically assessment (Modified visual analogue scale) [Time frame: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months]
- Clinically assessment (Millar's index) [Time frame: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months]
- Clinically assessment (presence or abscence) [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) [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) [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) [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) [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) [Time frame: 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Medicine, Suez canal university — Ismailia
Publications
- 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. PMID 32041360
- 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. PMID 28692829
- 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. PMID 33440268
Identifiers
NCT: NCT06372561 · Melatonin- vital pulp therapy