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

Not Applicable

Recruiting

• Conditions: Vital Pulp Therapy; Dental Caries in Children
• Interventions: Drug: Melatonin (dressing material); Drug: Mineral trioxide aggregate (dressing material)

• Registration Number: NCT06372561
• Lead Sponsor: Suez Canal University

Brief 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.

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 Timeline

• Study Start: 2023-05-20
• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2024-04-17
• Study First Posted: 2024-04-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2024-09-20
• Study Completion: 2024-10-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin	Melatonin (dressing material)	(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
Mineral Trioxide Aggregate	Mineral trioxide aggregate (dressing material)	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.
Mineral Trioxide and Melatonin	Mineral trioxide aggregate (dressing material)	Mixture of the two materials' powders.
Mineral Trioxide and Melatonin	Melatonin (dressing material)	Mixture of the two materials' powders.

Primary Outcome Measures

Name	Time	Method
Radiographic assessment (using Image J software program)	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)
Clinically assessment (presence or abscence)	Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months	changes in mucobuccal folds (swelling, redness, abscess,fistula)
Clinically assessment (Modified visual analogue scale)	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.
Clinically assessment (Millar's index)	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.

Trial Locations

Locations (1)

Faculty of Medicine, Suez canal university; 🇪🇬 Ismailia, Egypt