Pulp NecrosisNCT03813433
Discoloration of Endosequence and Mineral Trioxde Aggregate in Revascularization of Necrotic Immature Permanent Teeth
A study testing Revascularization in people with Pulp Necrosis, run by Cairo University.
Trial summary
the objective of this study is to evaluate post operative pain after using Endosequence versus Mineral Trioxide Aggregate as coronal plug material in revascularization of non vital immature anterior teeth Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Necrosis
- What is being tested?
- Revascularization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Nov 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age of patient range from 8-14 y.
- Patients are free from any systemic diseases that may hinder the normal healing process.
- Non vital permanent anterior teeth with open apex.
- 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 the procedure.
- Tooth with vital pulp or complete root formation.
- Teeth with internal or external root resorption.
- Un-cooperative patients
About this study
Official title: Discoloration After Revascularization Using Calcium Phosphosilicate Based Bioceramic vs Mineral Trioxide Aggregate in Necrotic Immature Permanent Anterior Teeth: A Randomized Clinical Trial
the objective of this study is to evaluate post operative pain after using Endosequence versus Mineral Trioxide Aggregate as coronal plug material in revascularization of non vital immature anterior teeth
Read the detailed description
The treatment of immature young permanent anterior teeth is challenging because in addition of the need of elimination of bacterial infection; the lack of natural apical constriction against which a suitable filling material can be placed is considered the main problem.
In the past many different treatments have been proposed for immature permanent teeth with necrotic pulps such as:Custom fitting of filling materials like gutta percha, Periapical surgeries, apexification. The disadvantages of these treatments are: the compromised Crown/root ratio, possibility of vertical fracture.
Pulp revascularization is dependent on the ability of residual pulp and apical and periodontal stem cells to differentiate. These cells have the ability to generate a highly vascularized and rich living tissue.
MTA was chosen as coronal seal to be placed over the blood clot due its a biocompatibility, bio-inductivity. However, the disadvantages of MTA are: discoloration of the coronal dentine when placed in the canal and the difficult handling properties.
Recently, a new bioceramic material has been introduced to the market, namely, EndoSequence which is bioactive, has antibacterial activity, less cytotoxic effect and similar antimicrobial properties, maintain color stability of the tooth when compared to MTA
- Conditions
- Pulp Necrosis
- Being tested
- Revascularization
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevascularizationOther
Also called pulp regeneration
a procedure used to regenerate pulp dentin complex that restores the functional properties of this immature anterior teeth, prevent and resolves apical periodontitis
| Study group | Role | What they receive |
|---|---|---|
| Enosequence | Experimental | 3-4 mm of Endosequence will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization Receives: Other: Revascularization |
| Mineral Trioxide Aggregate | Active comparator | 3-4 mm of Mineral Trioxide Aggregate will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization Receives: Other: Revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
discoloration
Asking patient question (Binary:present or absent)
Measured: 1 month
discoloration
Asking patient question (Binary:present or absent)
Measured: 3 months
dicoloration
Asking patient question (Binary:present or absent)
Measured: 6 months
discoloration
Asking patient question (Binary:present or absent)
Measured: 9 months
discoloration
Asking patient question (Binary:present or absent)
Measured: 12months
Secondary outcomes (6)
post operative pain
asking the patient (Binary: present or Absent)
Measured: 1,3, 6, 9 and 12 months
color stability
Operator and supervisor evaluation (Using shade guide)
Measured: 1,3, 6, 9 and 12 months
Pain on percussion
Assessed by back of the mirror (Binary: present or absent)
Measured: 1,3, 6, 9 and 12 months
Swelling
assessed by visual examination (Binary:present or absent)
Measured: 1,3, 6, 9 and 12 months
Sinus or fistula
assessed by visual examination (Binary:present or absent)
Measured: 1,3, 6, 9 and 12 months
Root lengthening
assessed radiographically (DIGORA® for Windows software)
Measured: 6 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 posted23 Jan 2019
- Study startJun 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp NecrosisStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Tarek Bartaw, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813433
- Sponsor's protocol ID
- pedodontic department cairo
- Status last verified
- Sep 2021
- First submitted
- 14 Jan 2019
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discoloration After Revascularization Using Calcium Phosphosilicate Based Bioceramic vs Mineral Trioxide Aggregate in Necrotic Immature Permanent Anterior Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03813433
- Acronym / sponsor ID
- pedodontic department cairo
- Conditions
- Pulp Necrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 23 Jan 2019 (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 objective of this study is to evaluate post operative pain after using Endosequence versus Mineral Trioxide Aggregate as coronal plug material in revascularization of non vital immature anterior teeth
Detailed description
The treatment of immature young permanent anterior teeth is challenging because in addition of the need of elimination of bacterial infection; the lack of natural apical constriction against which a suitable filling material can be placed is considered the main problem.
In the past many different treatments have been proposed for immature permanent teeth with necrotic pulps such as:Custom fitting of filling materials like gutta percha, Periapical surgeries, apexification. The disadvantages of these treatments are: the compromised Crown/root ratio, possibility of vertical fracture.
Pulp revascularization is dependent on the ability of residual pulp and apical and periodontal stem cells to differentiate. These cells have the ability to generate a highly vascularized and rich living tissue.
MTA was chosen as coronal seal to be placed over the blood clot due its a biocompatibility, bio-inductivity. However, the disadvantages of MTA are: discoloration of the coronal dentine when placed in the canal and the difficult handling properties.
Recently, a new bioceramic material has been introduced to the market, namely, EndoSequence which is bioactive, has antibacterial activity, less cytotoxic effect and similar antimicrobial properties, maintain color stability of the tooth when compared to MTA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enosequence | Experimental | Other: Revascularization3-4 mm of Endosequence will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization |
| Mineral Trioxide Aggregate | Active comparator | Other: Revascularization3-4 mm of Mineral Trioxide Aggregate will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age of patient range from 8-14 y.
- Patients are free from any systemic diseases that may hinder the normal healing process.
- Non vital permanent anterior teeth with open apex.
- Pulp space not needed for post and core for final restoration.
- Compliant patient/parent.
Key exclusion criteria (4 listed)
- Patients having allergy to medicaments and antibiotics necessary to complete the procedure.
- Tooth with vital pulp or complete root formation.
- Teeth with internal or external root resorption.
- Un-cooperative patients
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 |
|---|---|---|
| RevascularizationAlso: pulp regenerationa procedure used to regenerate pulp dentin complex that restores the functional properties of this immature anterior teeth, prevent and resolves apical periodontitis | Other | Enosequence, Mineral Trioxide Aggregate |
Primary outcome
discoloration
Time frame: 1 month
Asking patient question (Binary:present or absent)
discoloration
Time frame: 3 months
Asking patient question (Binary:present or absent)
dicoloration
Time frame: 6 months
Asking patient question (Binary:present or absent)
discoloration
Time frame: 9 months
Asking patient question (Binary:present or absent)
discoloration
Time frame: 12months
Asking patient question (Binary:present or absent)
6 secondary outcomes
post operative pain
Time frame: 1,3, 6, 9 and 12 months
color stability
Time frame: 1,3, 6, 9 and 12 months
Pain on percussion
Time frame: 1,3, 6, 9 and 12 months
Swelling
Time frame: 1,3, 6, 9 and 12 months
Sinus or fistula
Time frame: 1,3, 6, 9 and 12 months
Root lengthening
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Revascularization in people with Pulp Necrosis, run by Cairo University.
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 5 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 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
discoloration (time frame: 1 month). The study lists 5 primary outcomes in all. 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 19 Jul 2022.