Immature TeethNCT06119477
Three Techniques in Bioceramic Apexification for Necrotic Immature Incisors
A study testing Bioceramic Putty Apical Plugs, Single Cone Gutta-percha with Bioceramic Sealer and Combination of Bioceramic Putty and Sealer in people with Immature Teeth and Periapical Lesion, run by Damascus University at 1 site in Syria.
Trial summary
The goal of this randomized clinical trial is to find the most effective Bioceramic-based apexification procedures in children with immature necrotic maxillary incisors. The main questions they aims to answer are: What is the best Bioceramic apexification technique regarding the post-operative pain and the periapical… Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Immature Teeth, Periapical Lesion
- What is being tested?
- Bioceramic Putty Apical Plugs, Single Cone Gutta-percha with Bioceramic Sealer and Combination of Bioceramic Putty and Sealer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSyria
- Study dates
- 5 May 2023to 20 May 2025
- 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with one or more maxillary incisors with an open apex root (defined as root which root canal size equal or larger than #80 K-file) and presented with pulp necrosis and radiographic evidence of chronic apical periodontitis and periapical radiolucency greater than 3 mm.
Who cannot join
- Children with systemic diseases that compromised their general immune status.
- Uncooperative (definitely negative on the Frankl's behavioral scale).
- unrestorable incisors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Three Techniques in Bioceramic Apexification Procedure for Necrotic Immature Incisors: A Randomized Clinical Trial
The goal of this randomized clinical trial is to find the most effective Bioceramic-based apexification procedures in children with immature necrotic maxillary incisors. The main questions they aims to answer are:
- What is the best Bioceramic apexification technique regarding the post-operative pain and the periapical healing ?
- What is the best Bioceramic apexification technique regarding the bioceramics extrusion and the required time ? Participants will under gone Bioceramic apexification procedures which root canal preparing, disinfecting, filling, and restoring. Then, the patient will asked to come to follow-up appointments for clinical and radiological evaluations If there is a comparison group: Researchers will compare Bioceramic Putty Apical Plugs, Single Cone Gutta-percha with Bioceramic Sealer, and Combination of Bioceramic putty and sealer technique to find the best effective technique.
- Conditions
- Immature Teeth, Periapical Lesion
- Being tested
- Bioceramic Putty Apical Plugs, Single Cone Gutta-percha with Bioceramic Sealer, Combination of Bioceramic Putty and Sealer
- Keywords
- post-operative pain, periapical lesion healing, bioceramic apexification
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioceramic Putty Apical PlugsOther
Under local anesthesia and rubber dam isolation, the canal orifice will be prepared gently. The working length and apex diameter value will be recorded as a reference. Afterward, shaping and debridement the root canals will be achieved by gentle instrumentation. The canal will be irrigated copiously with NaOCl, then dried, and filled with Ca(OH)2 dressing. Afterward, the incisor will be temporarily restored. After 14 days the temporary filling and Ca(OH)2 will be removed. Afterward, canals will be irrigated with NaOCl and EDTA and dried. The Bioceramic Putty will be inserted in the apical 4 mm of the canal using the modified cannula and adapted to the canal walls with a hand plugger. The correct placement and thickness of the apical plug will be verified with a periapical radiograph. Afterward, the remainder of the root canal will be filled with gutta-percha with sealer. Finally, a suitable immediate final restoration was made for each case individually.
Single Cone Gutta-percha with Bioceramic SealerOther
Under local anesthesia and rubber dam isolation, the canal orifice will be prepared gently. The working length and apex diameter value will be recorded as a reference. Afterward, shaping and debridement the root canals will be achieved by gentle instrumentation. The canal will be irrigated copiously with NaOCl, dried, filled with Ca(OH)2 dressing and temporarily restored. After 14 days the temporary filling and Ca(OH)2 will be removed. Afterward, canals will be irrigated with NaOCl and EDTA and dried. A large sized gutta-percha cone (GC) will be inserted to the working length, The GC was ensured to make tag-back with the apical third of the immature canal and confirmed with a periapical radiograph. Then the immature canal will be gently filled with Bioceramic sealer and the GC will be placed again and another apical radiograph will be taken to confirm that the canal was properly filled. Finally, a suitable immediate final restoration was made for each case individually.
Combination of Bioceramic Putty and SealerOther
Under local anesthesia and rubber dam isolation, the canal orifice will be prepared gently. The working length and apex diameter value will be recorded as a reference. Afterward, shaping and debridement the root canals will be achieved by gentle instrumentation. The canal will be irrigated copiously with NaOCl, dried, filled with Ca(OH)2 dressing and temporarily restored. After 14 days the temporary filling and Ca(OH)2 will be removed. Afterward, canals will be irrigated with NaOCl and EDTA and dried.
The immature canal will be gently filled with Bioceramic sealer and then 3 to 5 small balls of BP (diameter of 1 mm) will be inserted into the canal orifice and gently plugged with hand pluggers. Afterward, an apical radiograph will be taken to confirm that the canal was properly filled without gaps and voids. Finally, a suitable immediate final restoration was made for each case individually.
| Study group | Role | What they receive |
|---|---|---|
| Bioceramic Putty Apical Plugs | Experimental | The Bioceramic Putty will be inserted in the apical 4 mm of the canal using the modified cannula and adapted to the canal walls with a hand plugger. Receives: Other: Bioceramic Putty Apical Plugs |
| Single Cone Gutta-percha with Bioceramic Sealer | Experimental | A large sized (#80 - #120, and a taper of 2%) gutta-percha cone (GC) will be inserted, measuring according to the width of the canal, to the working length, then the immature canal will be gently filled with Bioceramic sealer and the GC. Receives: Other: Single Cone Gutta-percha with Bioceramic Sealer |
| Combination of Bioceramic Putty and Sealer | Experimental | The immature canal will be gently filled with Bioceramic sealer and then 3 to 5 small balls of BP will be inserted into the canal orifice and gently plugged with hand pluggers. Receives: Other: Combination of Bioceramic Putty and Sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation
Patients of both groups will be recalled after 1, 3, 7, and 14 days of treatment and during radiographical assessment periods (3, 6 and 12 months), where they will be asked to rate their pain on the Wong-Baker Faces Scale, where children will set their pain levels by choosing a face; 0 = No Hurt, 1 = Hurts little bit, 2 = hurts Little more 3 = Hurts even more, 4 = Hurts whole lot, and 5 = Hurts worst. Moreover, the presence of fistula, swelling, and movement will be recorded.
Measured: 12 months
Radiographical assessment
After coronal restoration is completed a control x-ray will be taken. The periapical status will be assessed at the time of obturation-restoration, 3, 6, and 12 months following endodontic treatment. The outcome will be determined according to the Periapical Index scoring system: (1) normal periapical structures (The best); (2) small changes in bone structure; (3) changes in bone structure with some mineral loss; (4) periodontitis with well-defined radiolucent area; (5) severe periodontitis with exacerbating features (The worst).
The teeth will be evaluated according to healed, healing or unsuccessful as a primary radiographical outcome.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start5 May 2023
- Primary completion22 Aug 2024
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immature TeethStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osama Aljabban, Proffesor, Study director, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119477
- Sponsor's protocol ID
- UDDS-Pedo-06-2023
- Status last verified
- Aug 2025
- First submitted
- 22 Oct 2023
- Last updated
- 24 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only with contacting the main researcher
Publications
Tolibah YA, Kouchaji C, Lazkani T, Ahmad IA, Baghdadi ZD. Comparison of MTA versus Biodentine in Apexification Procedure for Nonvital Immature First Permanent Molars: A Randomized Clinical Trial. Children (Basel). 2022 Mar 14;9(3):410. doi: 10.3390/children9030410.
PubMed 35327782Alsayed Tolibah Y, Bshara N, Abbara MT, Alhaji M, Aljabban O, Ahmad IA, Baghdadi ZD. Root Development Following Bioceramic Material Application in Immature Permanent Teeth: A Case Series With 24-Month Follow-Up. Case Rep Dent. 2025 Oct 22;2025:1530438. doi: 10.1155/crid/1530438. eCollection 2025.
PubMed 41169957
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Techniques in Bioceramic Apexification Procedure for Necrotic Immature Incisors: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06119477
- Acronym / sponsor ID
- UDDS-Pedo-06-2023
- Conditions
- Immature Teeth, Periapical Lesion
- Keywords
- post-operative pain, periapical lesion healing, bioceramic apexification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 7 Nov 2023 (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 goal of this randomized clinical trial is to find the most effective Bioceramic-based apexification procedures in children with immature necrotic maxillary incisors. The main questions they aims to answer are:
- What is the best Bioceramic apexification technique regarding the post-operative pain and the periapical healing ?
- What is the best Bioceramic apexification technique regarding the bioceramics extrusion and the required time ? Participants will under gone Bioceramic apexification procedures which root canal preparing, disinfecting, filling, and restoring. Then, the patient will asked to come to follow-up appointments for clinical and radiological evaluations If there is a comparison group: Researchers will compare Bioceramic Putty Apical Plugs, Single Cone Gutta-percha with Bioceramic Sealer, and Combination of Bioceramic putty and sealer technique to find the best effective technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bioceramic Putty Apical Plugs | Experimental | Other: Bioceramic Putty Apical PlugsThe Bioceramic Putty will be inserted in the apical 4 mm of the canal using the modified cannula and adapted to the canal walls with a hand plugger. |
| Single Cone Gutta-percha with Bioceramic Sealer | Experimental | Other: Single Cone Gutta-percha with Bioceramic SealerA large sized (#80 - #120, and a taper of 2%) gutta-percha cone (GC) will be inserted, measuring according to the width of the canal, to the working length, then the immature canal will be gently filled with Bioceramic sealer and the GC. |
| Combination of Bioceramic Putty and Sealer | Experimental | Other: Combination of Bioceramic Putty and SealerThe immature canal will be gently filled with Bioceramic sealer and then 3 to 5 small balls of BP will be inserted into the canal orifice and gently plugged with hand pluggers. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients with one or more maxillary incisors with an open apex root (defined as root which root canal size equal or larger than #80 K-file) and presented with pulp necrosis and radiographic evidence of chronic apical periodontitis and periapical radiolucency greater than 3 mm.
Key exclusion criteria (3 listed)
- Children with systemic diseases that compromised their general immune status.
- Uncooperative (definitely negative on the Frankl's behavioral scale).
- unrestorable incisors.
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 |
|---|---|---|
| Bioceramic Putty Apical PlugsUnder local anesthesia and rubber dam isolation, the canal orifice will be prepared gently. The working length and apex diameter value will be recorded as a reference. Afterward, shaping and debridement the root canals will be achieved by gentle instrumentation. The canal will be irrigated copiously with NaOCl, then dried, and filled with Ca(OH)2 dressing. Afterward, the incisor will be temporarily restored. After 14 days the temporary filling and Ca(OH)2 will be removed. Afterward, canals will be irrigated with NaOCl and EDTA and dried. The Bioceramic Putty will be inserted in the apical 4 mm of the canal using the modified cannula and adapted to the canal walls with a hand plugger. The correct placement and thickness of the apical plug will be verified with a periapical radiograph. Afterward, the remainder of the root canal will be filled with gutta-percha with sealer. Finally, a suitable immediate final restoration was made for each case individually. | Other | Bioceramic Putty Apical Plugs |
| Single Cone Gutta-percha with Bioceramic SealerUnder local anesthesia and rubber dam isolation, the canal orifice will be prepared gently. The working length and apex diameter value will be recorded as a reference. Afterward, shaping and debridement the root canals will be achieved by gentle instrumentation. The canal will be irrigated copiously with NaOCl, dried, filled with Ca(OH)2 dressing and temporarily restored. After 14 days the temporary filling and Ca(OH)2 will be removed. Afterward, canals will be irrigated with NaOCl and EDTA and dried. A large sized gutta-percha cone (GC) will be inserted to the working length, The GC was ensured to make tag-back with the apical third of the immature canal and confirmed with a periapical radiograph. Then the immature canal will be gently filled with Bioceramic sealer and the GC will be placed again and another apical radiograph will be taken to confirm that the canal was properly filled. Finally, a suitable immediate final restoration was made for each case individually. | Other | Single Cone Gutta-percha with Bioceramic Sealer |
| Combination of Bioceramic Putty and SealerUnder local anesthesia and rubber dam isolation, the canal orifice will be prepared gently. The working length and apex diameter value will be recorded as a reference. Afterward, shaping and debridement the root canals will be achieved by gentle instrumentation. The canal will be irrigated copiously with NaOCl, dried, filled with Ca(OH)2 dressing and temporarily restored. After 14 days the temporary filling and Ca(OH)2 will be removed. Afterward, canals will be irrigated with NaOCl and EDTA and dried. The immature canal will be gently filled with Bioceramic sealer and then 3 to 5 small balls of BP (diameter of 1 mm) will be inserted into the canal orifice and gently plugged with hand pluggers. Afterward, an apical radiograph will be taken to confirm that the canal was properly filled without gaps and voids. Finally, a suitable immediate final restoration was made for each case individually. | Other | Combination of Bioceramic Putty and Sealer |
Primary outcome
Clinical evaluation
Time frame: 12 months
Patients of both groups will be recalled after 1, 3, 7, and 14 days of treatment and during radiographical assessment periods (3, 6 and 12 months), where they will be asked to rate their pain on the Wong-Baker Faces Scale, where children will set their pain levels by choosing a face; 0 = No Hurt, 1 = Hurts little bit, 2 = hurts Little more 3 = Hurts even more, 4 = Hurts whole lot, and 5 = Hurts worst. Moreover, the presence of fistula, swelling, and movement will be recorded.
Radiographical assessment
Time frame: 12 months
After coronal restoration is completed a control x-ray will be taken. The periapical status will be assessed at the time of obturation-restoration, 3, 6, and 12 months following endodontic treatment. The outcome will be determined according to the Periapical Index scoring system: (1) normal periapical structures (The best); (2) small changes in bone structure; (3) changes in bone structure with some mineral loss; (4) periodontitis with well-defined radiolucent area; (5) severe periodontitis with exacerbating features (The worst). The teeth will be evaluated according to healed, healing or unsuccessful as a primary radiographical outcome.
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 24 Aug 2025.
- Background: PubMed 35327782Tolibah YA, Kouchaji C, Lazkani T, Ahmad IA, Baghdadi ZD. Comparison of MTA versus Biodentine in Apexification Procedure for Nonvital Immature First Permanent Molars: A Randomized Clinical Trial. Children (Basel). 2022 Mar 14;9(3):410. doi: 10.3390/children9030410.
- Derived from this study: PubMed 41169957Alsayed Tolibah Y, Bshara N, Abbara MT, Alhaji M, Aljabban O, Ahmad IA, Baghdadi ZD. Root Development Following Bioceramic Material Application in Immature Permanent Teeth: A Case Series With 24-Month Follow-Up. Case Rep Dent. 2025 Oct 22;2025:1530438. doi: 10.1155/crid/1530438. eCollection 2025.
- Individual participant dataSharing planned: No. only with contacting the main researcher
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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.
Osama Aljabban, Proffesor study director
Damascus 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 Bioceramic Putty Apical Plugs, Single Cone Gutta-percha with Bioceramic Sealer and Combination of Bioceramic Putty and Sealer in people with Immature Teeth and Periapical Lesion, run by Damascus University at 1 site in Syria.
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 1 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 24 Aug 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 Syria. 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?
Clinical evaluation (time frame: 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 NCT06119477, which also lists 2 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 24 Aug 2025.