Nonvital ToothEarly Phase 1NCT03545139
Clinical & Radiographic Evaluation of Neo MTA Versus White MTA in Revascularization of Non-Vital Immature Permanent Teeth
A Early Phase 1 study testing NeoMTA nusmile and White MTA in people with Nonvital Tooth, run by Cairo University at 1 site in Egypt.
Trial summary
To evaluate and compare the degree of tooth discoloration in tooth crowns induced by Neo MTA versus white MTA over time. Evaluation of the effectiveness of Neo MTA as coronal plug in revascularization of immature teeth with necrotic pulp. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Nonvital Tooth
- What is being tested?
- NeoMTA nusmile and White MTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to Sep 2021
- Phase
- Early Phase 1
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age of patients: 7-15years old.
- Free from any systemic diseases that may affect the normal healing process.
- Tooth with immature root apex.
- Traumatically or cariously exposed non vital permanent anterior tooth.
- Pulp space not needed for post and core for final restoration.
- Compliant patient/parent
Who cannot join
- Patients having allergy to medicaments and antibiotics necessary to complete procedure.
- Tooth with vital pulp or complete root formation.
- Teeth with internal or external root resorption.
- Un-cooperative patients.
- Luxative injuries.
- Teeth with a root fracture
Show all 10Show fewer
- Alveolar fracture
- Subjects with chronic systemic illness.
- Subjects with poor oral hygiene.
- Compromised remaining tooth structure as teeth with extensive loss of coronal tissue will require restoration with a post that will occupy the space required for blood clot formation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral & Dental Medicine Cairo University
Cairo
Hala Tawfik, 01202555598, hallatawfeek@hotmail.com
About this study
Official title: Clinical and Radiographic Evaluation of Neo MTA Versus Conventional White MTA in Revascularization of Non-Vital Immature Permanent Anterior Teeth: A Randomized Controlled Trial
- To evaluate and compare the degree of tooth discoloration in tooth crowns induced by Neo MTA versus white MTA over time.
- Evaluation of the effectiveness of Neo MTA as coronal plug in revascularization of immature teeth with necrotic pulp.
Read the detailed description
The new formulation of MTA (NeoMTA) does not contain bismuth oxide, will be used in revascularization of nonvital immature permanent anterior teeth.
to evaluate the effectiveness of Neo MTA as coronal plug and compare the degree of tooth discoloration in tooth crowns induced by Neo MTA versus white MTA over time.
- Conditions
- Nonvital Tooth
- Being tested
- NeoMTA nusmile, White MTA
- Keywords
- pulp revascularization, endodontic regeneration, NeoMTA
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoMTA nusmileBiological
A new formulation of MTA was developed in which bismuth oxide was omitted.
White MTABiological
Revascularization with Conventional white mineral trioxide aggregate as coronal plug.
| Study group | Role | What they receive |
|---|---|---|
| NeoMTA (intervention group) | Experimental | Revascularization with NeoMTA as coronal plug. Receives: Biological: NeoMTA nusmile |
| White MTA (Control group) | Active comparator | Revascularization with Conventional white mineral trioxide aggregate (White MTA) as coronal plug. Receives: Biological: White MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discoloration/ Staining potential
Using spectrophotometer by operator
Measured: 9 month
Secondary outcomes (4)
Pain on biting
Verbal questioning of the patient
Measured: 9 month
Pain on percussion
Using back of the mirror
Measured: 9 month
Sinus or fistula, recurrent swelling
Visual examination by operator
Measured: 9 month
Root lengthening
Radiographic Digora image analysis software i.e. Digora for windows software DFW
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start1 Sep 2019
- Primary completionSep 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonvital ToothStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Ahmed Tawfik, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545139
- Sponsor's protocol ID
- NeoMTA in Revascularization
- Status last verified
- Feb 2020
- First submitted
- 22 May 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Neo MTA Versus Conventional White MTA in Revascularization of Non-Vital Immature Permanent Anterior Teeth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03545139
- Acronym / sponsor ID
- NeoMTA in Revascularization
- Conditions
- Nonvital Tooth
- Keywords
- pulp revascularization, endodontic regeneration, NeoMTA
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 4 Jun 2018 (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.
- To evaluate and compare the degree of tooth discoloration in tooth crowns induced by Neo MTA versus white MTA over time.
- Evaluation of the effectiveness of Neo MTA as coronal plug in revascularization of immature teeth with necrotic pulp.
Detailed description
The new formulation of MTA (NeoMTA) does not contain bismuth oxide, will be used in revascularization of nonvital immature permanent anterior teeth.
to evaluate the effectiveness of Neo MTA as coronal plug and compare the degree of tooth discoloration in tooth crowns induced by Neo MTA versus white MTA over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeoMTA (intervention group) | Experimental | Biological: NeoMTA nusmileRevascularization with NeoMTA as coronal plug. |
| White MTA (Control group) | Active comparator | Biological: White MTARevascularization with Conventional white mineral trioxide aggregate (White MTA) as coronal plug. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age of patients: 7-15years old.
- Free from any systemic diseases that may affect the normal healing process.
- Tooth with immature root apex.
- Traumatically or cariously exposed non vital permanent anterior tooth.
- Pulp space not needed for post and core for final restoration.
Key exclusion criteria (10 listed)
- Patients having allergy to medicaments and antibiotics necessary to complete procedure.
- Tooth with vital pulp or complete root formation.
- Teeth with internal or external root resorption.
- Un-cooperative patients.
- Luxative injuries.
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 |
|---|---|---|
| NeoMTA nusmileA new formulation of MTA was developed in which bismuth oxide was omitted. | Biological | NeoMTA (intervention group) |
| White MTARevascularization with Conventional white mineral trioxide aggregate as coronal plug. | Biological | White MTA (Control group) |
Primary outcome
Discoloration/ Staining potential
Time frame: 9 month
Using spectrophotometer by operator
4 secondary outcomes
Pain on biting
Time frame: 9 month
Pain on percussion
Time frame: 9 month
Sinus or fistula, recurrent swelling
Time frame: 9 month
Root lengthening
Time frame: 9 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NeoMTA nusmile and White MTA in people with Nonvital Tooth, run by Cairo 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 10 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 20 Feb 2020. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discoloration/ Staining potential (time frame: 9 month). 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 20 Feb 2020.