Dental Caries in ChildrenNCT06372561
Comparative Evaluation of Melatonin Versus MTA on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study
A study testing Mineral trioxide aggregate (dressing material) and Melatonin (dressing material) in people with Dental Caries in Children and Vital Pulp Therapy, run by Suez Canal University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children, Vital Pulp Therapy
- What is being tested?
- Mineral trioxide aggregate (dressing material) and Melatonin (dressing material)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2023to 2 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Internal root resorption.
- External root resorption.
- Inter radicular or periapical bone destruction (radiolucency)
- A deep carious lesion radiologically that approaches the pulp
Trial locations and contacts
1 site in 1 country.
Mennatallah Hesham El shaabany, doctorate student contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Suez canal university
Ismailia, 41522
Ismail Dahshan, PHD, 01012715799, dahshan1633@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Caries in Children, Vital Pulp Therapy
- Being tested
- Mineral trioxide aggregate (dressing material), Melatonin (dressing material)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral trioxide aggregate (dressing material)Drug
Also called MTA
MTA (Angulus Industrial de productus Odontologists S/a, Brazil) that applied on dental pulp for tissue regeneration
Melatonin (dressing material)Drug
Also called N-acetyl-5-methoxy-tryptamine
melatonin powder 250mg (sigma, Aldrich)- white powder mixing with saline and applied on dental pulp
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Melatonin (dressing material) |
| Mineral Trioxide and Melatonin | Experimental | Mixture of the two materials' powders. Receives: Drug: Mineral trioxide aggregate (dressing material); Drug: Melatonin (dressing material) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start20 May 2023
- Primary completion20 Sep 2024 (estimated)
- Study completion2 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gihan GED El-Desouky, Professor, Principal investigator, ProfessorGhada AH Elbaz, Professor, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372561
- Sponsor's protocol ID
- Melatonin- vital pulp therapy
- Status last verified
- Aug 2024
- First submitted
- 31 Oct 2023
- Last updated
- 2 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32041360Liu 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.
PubMed 28692829Vaseenon 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.
PubMed 33440268
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Melatonin Versus Mineral Trioxide Aggregate on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study
- ClinicalTrials.gov ID
- NCT06372561
- Acronym / sponsor ID
- Melatonin- vital pulp therapy
- Conditions
- Dental Caries in Children, Vital Pulp Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 2 Oct 2024 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mineral Trioxide Aggregate | Active comparator | Drug: 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. |
| Melatonin | Experimental | Drug: 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 and Melatonin | Experimental | Drug: Mineral trioxide aggregate (dressing material), Drug: Melatonin (dressing material)Mixture of the two materials' powders. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- Internal root resorption.
- External root resorption.
- Inter radicular or periapical bone destruction (radiolucency)
- A deep carious lesion radiologically that approaches the pulp
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mineral trioxide aggregate (dressing material)Also: MTAMTA (Angulus Industrial de productus Odontologists S/a, Brazil) that applied on dental pulp for tissue regeneration | Drug | Mineral Trioxide Aggregate, Mineral Trioxide and Melatonin |
| Melatonin (dressing material)Also: N-acetyl-5-methoxy-tryptaminemelatonin powder 250mg (sigma, Aldrich)- white powder mixing with saline and applied on dental pulp | Drug | Melatonin, Mineral Trioxide and Melatonin |
Primary outcome
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.
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.
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)
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)
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)
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.
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.
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Results publication: PubMed 32041360Guerrero-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.
- Results publication: PubMed 28692829Liu 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.
- Results publication: PubMed 33440268Vaseenon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mennatallah Hesham El shaabany, doctorate student contact
Gihan GED El-Desouky, Professor principal investigator
Professor
Ghada AH Elbaz, Professor principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mineral trioxide aggregate (dressing material) and Melatonin (dressing material) in people with Dental Caries in Children and Vital Pulp Therapy, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mennatallah Hesham El shaabany, doctorate student (01012906460 ext. 01005359111, menna.hesham@dent.suez.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically assessment (Modified visual analogue scale) (time frame: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06372561, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.