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

NCT06372561 | Recruiting

• 1 other identifier: Melatonin- vital pulp therapy
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries in Children; Vital Pulp Therapy

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Mineral Trioxide Aggregate

ACTIVE COMPARATOR

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)

Melatonin

EXPERIMENTAL

(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)

Mineral Trioxide and Melatonin

EXPERIMENTAL

Mixture of the two materials' powders.

Drug: Mineral trioxide aggregate (dressing material); Drug: Melatonin (dressing material)

Interventions

Mineral trioxide aggregate (dressing material) DRUG

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

Also known as: MTA

Mineral Trioxide Aggregate; Mineral Trioxide and Melatonin

Melatonin (dressing material) DRUG

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

Also known as: N-acetyl-5-methoxy-tryptamine

Melatonin; Mineral Trioxide and Melatonin

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Internal root resorption.
• External root resorption.
• Inter radicular or periapical bone destruction (radiolucency)
• A deep carious lesion radiologically that approaches the pulp

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of Medicine, Suez canal university

Ismailia, 41522, Egypt

RECRUITING

Related 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: 10.3390/ijerph17031043.

  PMID: 32041360 RESULT

• 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.

  PMID: 28692829 RESULT

• 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 2021 Jan 6.

  PMID: 33440268 RESULT

MeSH Terms

Interventions

mineral trioxide aggregate; Pemetrexed; Melatonin

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Tryptamines; Indoles; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Gihan GED El-Desouky, Professor

  Professor

  PRINCIPAL INVESTIGATOR

• Ghada AH Elbaz, Professor

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mennatallah Hesham El shaabany, doctorate student

CONTACT

01012906460; menna.hesham@dent.suez.edu.eg

Asmaa Ali Abo El-Soud, Associate professor

CONTACT

01220989854; asmaa_ali@dent.suez.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: April 18, 2024
• Study Start: May 20, 2023
• Primary Completion: September 20, 2024
• Study Completion: October 2, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

EG (1)