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NCT Number: NCT06372561

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

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.

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Key information

Conditions

Dental Caries in Children Vital Pulp Therapy

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Suez canal university

Ismailia, 41522, Egypt

Location status: Recruiting

Location contact

Ismail Dahshan, PHD

CONTACT

[email protected]

01012715799

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mineral trioxide aggregate (dressing material)

Drug

MTA (Angulus Industrial de productus Odontologists S/a, Brazil) that applied on dental pulp for tissue regeneration

Other names: MTA

Melatonin (dressing material)

Drug

melatonin powder 250mg (sigma, Aldrich)- white powder mixing with saline and applied on dental pulp

Other names: N-acetyl-5-methoxy-tryptamine

Primary outcomes

  1. Clinically assessment (Modified visual analogue scale)

    Time frame: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months

    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.

  2. Clinically assessment (Millar's index)

    Time frame: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months

    tooth mobility (classes I,II,III) from less mobility to higher mobility.

  3. Clinically assessment (presence or abscence)

    Time frame: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months

    changes in mucobuccal folds (swelling, redness, abscess,fistula)

  4. 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

    Density of calcific tissue (dentinal bridge) underneath MTA, Melatonin and their mixture (the 3 groups) (Densitometric analysis)

  5. 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

    Thickness of calcific tissue (dentinal bridge) underneath MTA, Melatonin and their mixture (the 3 groups)

  6. 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

    Width of apical foramina for the 3 groups.

  7. 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

    Linear radiographic measurement of root development.

  8. 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

    Assessment of changes in bone density surrounding the treated teeth (Densiometric analysis)

Study contacts

Contact information is provided by the study sponsor or research team.

Asmaa Ali Abo El-Soud, Associate professor

CONTACT

[email protected]

01220989854

Mennatallah Hesham El shaabany, doctorate student

CONTACT

[email protected]

01012906460 ext. 01005359111

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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