Clinical trial NCT06372561: Comparative Evaluation of Melatonin Versus MTA on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study
Official title: Comparative Evaluation of Melatonin Versus Mineral Trioxide Aggregate on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Caries in Children
Vital Pulp Therapy
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinically assessment (Modified visual analogue scale)
timeFrame: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
measure: Clinically assessment (Millar's index)
timeFrame: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
measure: Clinically assessment (presence or abscence)
timeFrame: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
measure: Radiographic assessment (using Image J software program)
timeFrame: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
measure: Radiographic assessment (using Image J software program)
timeFrame: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
measure: Radiographic assessment (using Image J software program)
timeFrame: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
measure: Radiographic assessment (using Image J software program)
timeFrame: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
measure: Radiographic assessment (using Image J software program)
timeFrame: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Faculty of Medicine, Suez canal university
Study officials:
affiliation: Professor
name: Gihan GED El-Desouky, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor
name: Ghada AH Elbaz, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.