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

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06372561
• Other study ID #: Melatonin- vital pulp therapy
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2023
• Est. completion date: June 20, 2024

Study information

• Verified date: October 2023
• Source: Suez Canal University
• Contact: Mennatallah Hesham El shaabany, doctorate student
• Phone: 01012906460
• Email: menna.hesham[@]dent.suez.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 20, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children
• Vital Pulp Therapy

Intervention

Drug:
• Mineral trioxide aggregate (dressing material)
MTA (Angulus Industrial de productus Odontologists S/a, Brazil) that applied on dental pulp for tissue regeneration
• Melatonin (dressing material)
melatonin powder 250mg (sigma, Aldrich)- white powder mixing with saline and applied on dental pulp

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Suez canal university	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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: 10.3 — View 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. — View 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 202 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically assessment (Modified visual analogue scale)	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
Primary	Clinically assessment (Millar's index)	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
Primary	Clinically assessment (presence or abscence)	changes in mucobuccal folds (swelling, redness, abscess,fistula)	Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
Primary	Radiographic assessment (using Image J software program)	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
Primary	Radiographic assessment (using Image J software program)	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
Primary	Radiographic assessment (using Image J software program)	Width of apical foramina for the 3 groups.	Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
Primary	Radiographic assessment (using Image J software program)	Linear radiographic measurement of root development.	Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
Primary	Radiographic assessment (using Image J software program)	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