Periapical PeriodontitisNCT06322979
Premixed Bioceramic Putty as an Apical Plug in Immature Anterior Permanent Teeth
A study testing Mineral trioxide aggregate and Premixed Bioceramic Putty in people with Periapical Periodontitis, run by Tanta University at 1 site in Egypt.
Trial summary
Following the randomization procedure, children will be divided into 2 groups (25 immature anterior permanent incisors in each group): Group I will be treated with MTA as apical plug while group II will be treated with Premixed Bioceramic Putty as apical plug. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Periapical Periodontitis
- What is being tested?
- Mineral trioxide aggregate and Premixed Bioceramic Putty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Nov 2023to 5 Dec 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- nonvital immature permanent teeth as a consequence of trauma or dental caries
- nonvital permanent teeth with radiographic evidence of immature root end development
- clinically restorable teeth
Who cannot join
- immature nonvital permanent teeth presenting with signs/symptoms of internal/external resorption, moderate to severe mobility, periodontal bone loss
- Immature nonvital permanent teeth associated with developmental abnormalities.
- Patients with a history of systemically debilitating diseases
- unrestorable remaining crown structure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Premixed Bioceramic Putty Versus MTA as Apical Plugs in Nonvital Immature Anterior Teeth: A Clinical Randomized Controlled Trial
Following the randomization procedure, children will be divided into 2 groups (25 immature anterior permanent incisors in each group): Group I will be treated with MTA as apical plug while group II will be treated with Premixed Bioceramic Putty as apical plug. After working length determination, instrumentation, and irrigation of the root canals, apical plug will be done. in MTA Group, MTA will be placed into the apical 4 mm of root canals, then a moist cotton pellet will be placed and the access cavity will be restored with glass-ionomer-based restoration. Next day, glass-ionomer-based restoration and the cotton pellet will be removed, then the coronal restoration will be completed with GIC, composite. In the Premixed Bioceramic Putty group, Well-Root™ PT will be placed into the apical 4 mm of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.
children will be recalled for clinical and radiographical follow-up after 6 and12 months after treatment.
- Conditions
- Periapical Periodontitis
- Being tested
- Mineral trioxide aggregate, Premixed Bioceramic Putty
- Keywords
- immature teeth, apexification, apical plug
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral trioxide aggregateProcedure or surgery
Apexification treatment was done with mineral trioxide aggregate
Premixed Bioceramic PuttyProcedure or surgery
Apexification treatment was done with Premixed Bioceramic Putty (Well-Root™ PT)
| Study group | Role | What they receive |
|---|---|---|
| MTA group | Active comparator | After the endodontic procedure, MTA will be placed into the apical 4 mm of the root canals. then a moist cotton pellet will be placed and the access cavity will be restored with GIC. Next day, GIC and the cotton pellet will be removed the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite. Receives: Procedure: Mineral trioxide aggregate |
| Premixed Bioceramic Putty group | Experimental | After the endodontic procedure, Premixed Bioceramic Putty (Well-Root™ PT) will be placed into the apical 4mm of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite. Receives: Procedure: Premixed Bioceramic Putty |
What is being measured
The primary outcome is the main question the study is designed to answer.
the clinical success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)
The apexification procedure will be recorded as a clinical success if the tooth fulfils the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.
Measured: up to 12 months
the radiographic success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)
The apexification procedure will be recorded to be radiographically successful if it demonstrates the following criteria: (1) reduction of apical lesion size (2) Normal periodontal ligament space (2) No furcation pathosis, and (3) No external resorption.
The apexification procedure will be radiographically unsuccessful if the apical lesion size increases.
The apexification procedure will be doubtful if the apical lesion size doesn't change
Measured: at 6 and12 months follow up
Secondary outcomes (1)
Change in the periapical index (PAI)
Radio-graphically, the periapical index provides an ordinal scale of 5 scores ranging from ''healthy'' to ''severe periodontitis with exacerbating features''. (1) Normal periapical structures. (2) Small changes in bone structure. (3) Changes in bone structure with some diffuse mineral loss. (4) Periodontitis with well-defined radiolucent area. (5) Severe periodontitis with exacerbating features. (1, 2: healthy and 3, 4, 5: pathological).
Measured: at 6 and12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start22 Nov 2023
- Primary completion12 Nov 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periapical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Shaban Mohamed El-desouky, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322979
- Sponsor's protocol ID
- # R-PED-11-23-3074
- Status last verified
- Apr 2025
- First submitted
- 14 Mar 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986 Feb;2(1):20-34. doi: 10.1111/j.1600-9657.1986.tb00119.x. No abstract available.
PubMed 3457698
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Premixed Bioceramic Putty Versus MTA as Apical Plugs in Nonvital Immature Anterior Teeth: A Clinical Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06322979
- Acronym / sponsor ID
- # R-PED-11-23-3074
- Conditions
- Periapical Periodontitis
- Keywords
- immature teeth, apexification, apical plug
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 21 Mar 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.
Following the randomization procedure, children will be divided into 2 groups (25 immature anterior permanent incisors in each group): Group I will be treated with MTA as apical plug while group II will be treated with Premixed Bioceramic Putty as apical plug. After working length determination, instrumentation, and irrigation of the root canals, apical plug will be done. in MTA Group, MTA will be placed into the apical 4 mm of root canals, then a moist cotton pellet will be placed and the access cavity will be restored with glass-ionomer-based restoration. Next day, glass-ionomer-based restoration and the cotton pellet will be removed, then the coronal restoration will be completed with GIC, composite. In the Premixed Bioceramic Putty group, Well-Root™ PT will be placed into the apical 4 mm of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.
children will be recalled for clinical and radiographical follow-up after 6 and12 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTA group | Active comparator | Procedure: Mineral trioxide aggregateAfter the endodontic procedure, MTA will be placed into the apical 4 mm of the root canals. then a moist cotton pellet will be placed and the access cavity will be restored with GIC. Next day, GIC and the cotton pellet will be removed the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite. |
| Premixed Bioceramic Putty group | Experimental | Procedure: Premixed Bioceramic PuttyAfter the endodontic procedure, Premixed Bioceramic Putty (Well-Root™ PT) will be placed into the apical 4mm of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- nonvital immature permanent teeth as a consequence of trauma or dental caries
- nonvital permanent teeth with radiographic evidence of immature root end development
- clinically restorable teeth
Key exclusion criteria (4 listed)
- immature nonvital permanent teeth presenting with signs/symptoms of internal/external resorption, moderate to severe mobility, periodontal bone loss
- Immature nonvital permanent teeth associated with developmental abnormalities.
- Patients with a history of systemically debilitating diseases
- unrestorable remaining crown structure
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 aggregateApexification treatment was done with mineral trioxide aggregate | Procedure or surgery | MTA group |
| Premixed Bioceramic PuttyApexification treatment was done with Premixed Bioceramic Putty (Well-Root™ PT) | Procedure or surgery | Premixed Bioceramic Putty group |
Primary outcome
the clinical success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)
Time frame: up to 12 months
The apexification procedure will be recorded as a clinical success if the tooth fulfils the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.
the radiographic success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA)
Time frame: at 6 and12 months follow up
The apexification procedure will be recorded to be radiographically successful if it demonstrates the following criteria: (1) reduction of apical lesion size (2) Normal periodontal ligament space (2) No furcation pathosis, and (3) No external resorption. The apexification procedure will be radiographically unsuccessful if the apical lesion size increases. The apexification procedure will be doubtful if the apical lesion size doesn't change
1 secondary outcome
Change in the periapical index (PAI)
Time frame: at 6 and12 months follow up
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 18 Apr 2025.
- Background: PubMed 3457698Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986 Feb;2(1):20-34. doi: 10.1111/j.1600-9657.1986.tb00119.x. No abstract available.
- Individual participant dataSharing planned: No
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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.
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 and Premixed Bioceramic Putty in people with Periapical Periodontitis, run by Tanta 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 3 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: finished, as of the sponsor's last update on 18 Apr 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?
the clinical success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA) (time frame: up to 12 months). The study lists 2 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 NCT06322979, which also lists 1 linked publication.
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 18 Apr 2025.