Vital Pulp TherapyNCT05498337
Vital Pulp Therapy With Different Materials for Young Permanent Teeth
A study testing calcium hydroxide, MTA and Diode Laser in people with Vital Pulp Therapy, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will be conducted to: Evaluate clinically and radiographically apexogenesis in immature permanent molars using: 1. Calcium Hydroxide. 2. MTA. 3. Laser. 4. Laser combined with MTA. Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Vital Pulp Therapy
- What is being tested?
- calcium hydroxide, MTA and Diode Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 1 Apr 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 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Medically free
- Vital teeth
Who cannot join
- Medically compromised
- Chronic abscess
- Non-vital teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Different Treatment Modalities for Vital Pulp of Immature Permanent Molars
This study will be conducted to:
Evaluate clinically and radiographically apexogenesis in immature permanent molars using:
- Calcium Hydroxide.
- MTA.
- Laser.
- Laser combined with MTA.
Read the detailed description
Calcium Hydroxide has been the most commonly utilized pulpotomy agent for vital pulp therapy. It is the earliest medicament employed in pulpotomy that possesses the ability to stimulate tertiary dentinogenesis. This is attributed to its high alkalinity after mixing with water. Calcium hydroxide has a high pH, and its dental use relates chiefly to its ability to stimulate mineralization and also to its antibacterial property.
Biocompatibility and sealing ability are the most important properties, which account for optimal healing response in vital pulp therapy. Unlike conventional materials, MTA has low solubility and maintains its physical integrity after placement. It has several desirable characteristics in terms of biocompatibility, bioactivity, hydrophilicity, radiopacity, sealing ability and low solubility.
Diode laser in a young permanent tooth with traumatically exposed pulp has proved to be an effective technique for Pulpotomy in an immature tooth. Therefore, the use of soft-tissue diode lasers can influence the treatment outcome and should be seen as a predicable tool for vital pulp therapy.
- Conditions
- Vital Pulp Therapy
- Being tested
- calcium hydroxide, MTA, Diode Laser
- Keywords
- Alpexogenesis, MTA, Calcium hydroxide, Diode Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium hydroxideOther
Dental pulp medicament material
MTAOther
Dental pulp medicament material
Diode LaserDevice
Device used in pulp therapy
| Study group | Role | What they receive |
|---|---|---|
| Examiner | Other | Examiner Receives: Other: calcium hydroxide; Other: MTA; Device: Diode Laser |
| Patient | No intervention | Patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root completion
Closure of radiographic apex using Scanora 5.2.6 digital software
Measured: one year
Secondary outcomes (1)
Root lengthening and thickening
Measuring the increase in length and width of the root canals using Scanora 5.2.6 digital software
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Sep 2022
- Primary completion30 Sep 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Pulp TherapyStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada mohamed, Mansoura University
- Investigators
- Salwa M Awad, Professor, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498337
- Sponsor's protocol ID
- Vital pulp therapy
- Status last verified
- Sep 2025
- First submitted
- 10 Aug 2022
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Different Treatment Modalities for Vital Pulp of Immature Permanent Molars
- ClinicalTrials.gov ID
- NCT05498337
- Acronym / sponsor ID
- Vital pulp therapy
- Conditions
- Vital Pulp Therapy
- Keywords
- Alpexogenesis, MTA, Calcium hydroxide, Diode Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 12 Aug 2022 (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.
This study will be conducted to:
Evaluate clinically and radiographically apexogenesis in immature permanent molars using:
- Calcium Hydroxide.
- MTA.
- Laser.
- Laser combined with MTA.
Detailed description
Calcium Hydroxide has been the most commonly utilized pulpotomy agent for vital pulp therapy. It is the earliest medicament employed in pulpotomy that possesses the ability to stimulate tertiary dentinogenesis. This is attributed to its high alkalinity after mixing with water. Calcium hydroxide has a high pH, and its dental use relates chiefly to its ability to stimulate mineralization and also to its antibacterial property.
Biocompatibility and sealing ability are the most important properties, which account for optimal healing response in vital pulp therapy. Unlike conventional materials, MTA has low solubility and maintains its physical integrity after placement. It has several desirable characteristics in terms of biocompatibility, bioactivity, hydrophilicity, radiopacity, sealing ability and low solubility.
Diode laser in a young permanent tooth with traumatically exposed pulp has proved to be an effective technique for Pulpotomy in an immature tooth. Therefore, the use of soft-tissue diode lasers can influence the treatment outcome and should be seen as a predicable tool for vital pulp therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Examiner | Other | Other: calcium hydroxide, Other: MTA, Device: Diode LaserExaminer |
| Patient | No intervention | –Patient |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Medically free
- Vital teeth
Key exclusion criteria (3 listed)
- Medically compromised
- Chronic abscess
- Non-vital teeth
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 |
|---|---|---|
| calcium hydroxideDental pulp medicament material | Other | Examiner |
| MTADental pulp medicament material | Other | Examiner |
| Diode LaserDevice used in pulp therapy | Device | Examiner |
Primary outcome
Root completion
Time frame: one year
Closure of radiographic apex using Scanora 5.2.6 digital software
1 secondary outcome
Root lengthening and thickening
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
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Laser-Assisted vs Conventional Total Pulpotomy in Symptomatic Irreversible Pulpitis
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Not yet recruitingObservational study
Prognostic Value of Pulpal Blood pH and Oxygen Saturation in Vital Pulp Therapy: Determination of Clinically Relevant Thresholds in a Prospective Clinical Study
Vital Pulp Therapies, pH
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Clinical Evaluation of Discoloration Induced by Root Canal Treatment in Vital and Devital Teeth
Tooth Discoloration Following Root Canal Treatment, Tooth Discoloration
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.
Salwa M Awad, Professor study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calcium hydroxide, MTA and Diode Laser in people with Vital Pulp Therapy, run by Mansoura 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 2 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root completion (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2025.