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

Last updated: August 1, 2024
Sponsor: Suez Canal University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Melatonin (dressing material)

Mineral trioxide aggregate (dressing material)

Clinical Study ID

NCT06372561
Melatonin- vital pulp therapy
  • Ages 6-8
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1- Apparently healthy and medically free children. 2- Their age ranges from 6-8years. 3- Both boys and girls will be included. 4- Children should have mandibularpermanent first molars with the following clinical and radiographic criteria. 4.1Restorable young permanent first molars. 4.2Absence of clinical evidence of pulpdegeneration:

  • No history of spontaneous pain, history of night pain or pain that not relieved byanalgesics.

  • 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

Exclusion Criteria:

  • Internal root resorption.

  • External root resorption.

  • Inter radicular or periapical bone destruction (radiolucency)

  • A deep carious lesion radiologically that approaches the pulp

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: Melatonin (dressing material)
Phase:
Study Start date:
May 20, 2023
Estimated Completion Date:
October 02, 2024

Study 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.

Connect with a study center

  • Faculty of Medicine, Suez canal university

    Ismailia, 41522
    Egypt

    Active - Recruiting

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