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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-20

Study Completion Date

2024-10-02

Brief Summary

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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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Detailed Description

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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.

Conditions

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Dental Caries in Children Vital Pulp Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Mineral Trioxide Aggregate

is a powder that consist of Calcium oxide, silicone dioxide, aluminum oxide, bismuth oxide, purified water. It is a bactericidal dressing material, promotes pulp healing, and does so without producing inflammation and promotes dentin bridge formation.

Group Type ACTIVE_COMPARATOR

Mineral trioxide aggregate (dressing material)

Intervention Type DRUG

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

Melatonin

(N-acetyl-5-methoxy-tryptamine) is a pleiotropic hormone synthesized in the pineal gland that has important chronobiotic properties. there is a Melatonin drug (powder) that proved to play an essential role in the regulation of bone growth (bone regeneration) and it may promote osteoblast differentiation, and stimulates mineralized matrix formation

Group Type EXPERIMENTAL

Melatonin (dressing material)

Intervention Type DRUG

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

Mineral Trioxide and Melatonin

Mixture of the two materials' powders.

Group Type EXPERIMENTAL

Mineral trioxide aggregate (dressing material)

Intervention Type DRUG

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

Melatonin (dressing material)

Intervention Type DRUG

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

Interventions

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Mineral trioxide aggregate (dressing material)

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

Intervention Type DRUG

Melatonin (dressing material)

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

Intervention Type DRUG

Other Intervention Names

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MTA N-acetyl-5-methoxy-tryptamine

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes