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

April 17, 2024 updated by: Suez Canal University

Comparative Evaluation of Melatonin Versus Mineral Trioxide Aggregate 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Ismailia, Egypt, 41522
        • Recruiting
        • Faculty of Medicine, Suez canal university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Mineral trioxide aggregate (dressing material)
MTA (Angulus Industrial de productus Odontologists S/a, Brazil) that applied on dental pulp for tissue regeneration
Other Names:
  • MTA
Experimental: 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
Drug: Melatonin (dressing material)
melatonin powder 250mg (sigma, Aldrich)- white powder mixing with saline and applied on dental pulp
Other Names:
  • N-acetyl-5-methoxy-tryptamine
Experimental: Mineral Trioxide and Melatonin
Mixture of the two materials' powders.
Drug: Mineral trioxide aggregate (dressing material)
MTA (Angulus Industrial de productus Odontologists S/a, Brazil) that applied on dental pulp for tissue regeneration
Other Names:
  • MTA
Drug: Melatonin (dressing material)
melatonin powder 250mg (sigma, Aldrich)- white powder mixing with saline and applied on dental pulp
Other Names:
  • N-acetyl-5-methoxy-tryptamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
tooth mobility (classes I,II,III) from less mobility to higher mobility.
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
changes in mucobuccal folds (swelling, redness, abscess,fistula)
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
Density of calcific tissue (dentinal bridge) underneath MTA, Melatonin and their mixture (the 3 groups) (Densitometric analysis)
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
Thickness of calcific tissue (dentinal bridge) underneath MTA, Melatonin and their mixture (the 3 groups)
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
Width of apical foramina for the 3 groups.
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
Linear radiographic measurement of root development.
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
Assessment of changes in bone density surrounding the treated teeth (Densiometric analysis)
Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Investigators

  • Principal Investigator: Gihan GED El-Desouky, Professor, Professor
  • Principal Investigator: Ghada AH Elbaz, Professor, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2023

Primary Completion (Estimated)

May 20, 2024

Study Completion (Estimated)

June 20, 2024

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Melatonin- vital pulp therapy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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