Revascularization of Immature Young Permenant TeethPhase 2NCT06630156
The Present Study Was Conducted to Evaluate Bioceramic Root Repair Material Versus Bio MTA in Revascularization of Immature Young Permenant Teeth.
A Phase 2 study testing Revascularization of Immature Young Permenant Teeth in people with Revascularization of Immature Young Permenant Teeth, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The present clinical study wasdirected to evaluate bioceramic root repair material versus Bio MTA in Revascularization of Immature Young Permenant Teeth through: 1. Clinical evaluation including: Pain, swelling, sinus or fistula, mobility and crown discoloration. 2. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Revascularization of Immature Young Permenant Teeth
- What is being tested?
- Revascularization of Immature Young Permenant Teeth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Aug 2022to 21 Dec 2024
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child with an age ranged from (7-12) year from both sexes.
- Patient and parent cooperation.
- Non vital immature permanent teeth indicated for endodontic treatment as a result of pulp necrosis.
- Patient is not taking antibiotic and has not taken for the past 2 weeks.
- Restorable teeth.
- The root to crown ratio should be at least 1:1.
Who cannot join
- Patients allergic to any drug used in this RCT.
- Patients with any systemic disease that would contraindicate pulp therapy (rheumatic fever, infective endocarditis, leukemia, corticosteroid therapy and immune suppressed children).
- Tooth with vital pulp or complete root formation.
- Teeth with draining sinus or periodontal weak mobile teeth.
- Teeth with internal or external root resorption.
- Tooth with root fracture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Bioceramic Root Repair Versus Bio MTA in Revascularization of Immature Young Permenant Teeth.
The present clinical study wasdirected to evaluate bioceramic root repair material versus Bio MTA in Revascularization of Immature Young Permenant Teeth through:
- Clinical evaluation including: Pain, swelling, sinus or fistula, mobility and crown discoloration.
- Radiographic evaluation including: Root lengthening, continued thickening of the dentinal walls, apical closure and regression of the peri-apical lesion.
Read the detailed description
In a young permanent tooth with pulp necrosis and apical pathosis, routine endodontic treatment may not be possible due to the immature apex it possesses. Newer methods based on the principles of revascularization and regeneration have been tried and found to be much better than the traditional methods of apexification since it helps in physiological root maturation, unlike traditional methods which result in only artificial barrier formation without root lengthening.
Revascularization is a new treatment method for immature necrotic permanent teeth. Indeed, it would provide, after treatment, a vital tooth that would be able to complete its root maturation. Three key requirements for a successful revascularization are: (a) Root canal disinfection; (b) matrix inside the canal for growth of tissue (scaffold); and (c) a tight seal access filling.
Bio MTA was introduced to overcome some of the drawbacks of MTA such as handling properties and long setting time. Bio MTA has a faster setting time with good handling characteristics and biological properties. Calcium silicate based restorative cements were formulated using different calcium compounds such as calcium hydroxide, calcium oxide, calcium phosphate, calcium sulfate, calcium silicate, and calcium carbonate in combination with zirconium. The mixed cement comprises water-soluble calcium and phosphate and immediately forms hydroxyapatite during and after setting.
A Total Fill biocearmic root repair material which is calcium silicate-based cement was developed with excellent handling properties as it is supplied in premixed packages (putty) that do not require preparation before use. It is mainly composed of calcium silicate, monobasic calcium phosphate, calcium hydroxide, and zirconium oxide. It has antibacterial and antifungal activities. It is claimed that the material is biocompatible with human periodontal tissues.
- Being tested
- Revascularization of Immature Young Permenant Teeth
- Keywords
- Revascularization, Bio MTA, Total Fill biocearmic root repair material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revascularization of Immature Young Permenant TeethBiological
An access cavity was prepared under rubber dam, isolation, root canal system disinfection was done without mechanical instrumentation. Subsequently, triple antibiotic paste was placed into the apical portion of the canal and filled to just below the CEJ. The access cavity was temporarily restored with glass ionomer.
4 weeks later, after reopening of the access, the antibiotic paste was gently flushed out of the canal with sterile normal saline. The root canal system was irrigated. A sterile #35 K-file will be introduced into the canal beyond the apical foramen using a push and pull motion to provoke bleeding from the periapical tissue. After bleeding control and formation of fresh blood clot, 3 mm of Bio (MTA) will be placed in Group A, 3 mm of Total Fill biocearmic root repair material will be placed in Group B after a moist cotton pellet was placed over the capping material and the access cavity will be sealed with G C
| Study group | Role | What they receive |
|---|---|---|
| Bio-MTA revascularization | Active comparator | Not described Receives: Biological: Revascularization of Immature Young Permenant Teeth |
| Total Fill biocearmic root repair material revascularization | Active comparator | Not described Receives: Biological: Revascularization of Immature Young Permenant Teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic parameters
continued root lengthening and thickening of the dentinal walls in mm
Measured: baseline, 3, 6, and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start21 Aug 2022
- Primary completion21 Nov 2024 (estimated)
- Study completion21 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Revascularization of Immature Young Permenant 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients selected in this study were randomly divided into 2 groups: 1. Group A: 14 teeth were disinfected by triple paste and treated by Bio-MTA. 2. Group A: 14 teeth were disinfected by triple paste and treated by a Total Fill biocearmic root repair.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reda Mohammed Mohammed Elsayed, Al-Azhar University
- Investigators
- Reda Mohammed Elsayed, assistant lecturer, Principal investigator, Faculty of Dental Medicine, Al- Azhar University, Assuit, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630156
- Sponsor's protocol ID
- Treatment of immature teeth
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Murray PE, Garcia-Godoy F, Hargreaves KM. Regenerative endodontics: a review of current status and a call for action. J Endod. 2007 Apr;33(4):377-90. doi: 10.1016/j.joen.2006.09.013. Epub 2007 Feb 20.
PubMed 17368324Kim DS, Park HJ, Yeom JH, Seo JS, Ryu GJ, Park KH, Shin SI, Kim SY. Long-term follow-ups of revascularized immature necrotic teeth: three case reports. Int J Oral Sci. 2012 Jun;4(2):109-13. doi: 10.1038/ijos.2012.23.
PubMed 22627612Bose R, Nummikoski P, Hargreaves K. A retrospective evaluation of radiographic outcomes in immature teeth with necrotic root canal systems treated with regenerative endodontic procedures. J Endod. 2009 Oct;35(10):1343-9. doi: 10.1016/j.joen.2009.06.021. Epub 2009 Aug 15.
PubMed 19801227Shuping GB, Orstavik D, Sigurdsson A, Trope M. Reduction of intracanal bacteria using nickel-titanium rotary instrumentation and various medications. J Endod. 2000 Dec;26(12):751-5. doi: 10.1097/00004770-200012000-00022.
PubMed 11471648Chen MY, Chen KL, Chen CA, Tayebaty F, Rosenberg PA, Lin LM. Responses of immature permanent teeth with infected necrotic pulp tissue and apical periodontitis/abscess to revascularization procedures. Int Endod J. 2012 Mar;45(3):294-305. doi: 10.1111/j.1365-2591.2011.01978.x. Epub 2011 Nov 14.
PubMed 22077958Asgary S, Fazlyab M, Nosrat A. Regenerative Endodontic Treatment versus Apical Plug in Immature Teeth: Three-Year Follow-Up. J Clin Pediatr Dent. 2016;40(5):356-60. doi: 10.17796/1053-4628-40.5.356.
PubMed 27617375Chuensombat S, Khemaleelakul S, Chattipakorn S, Srisuwan T. Cytotoxic effects and antibacterial efficacy of a 3-antibiotic combination: an in vitro study. J Endod. 2013 Jun;39(6):813-9. doi: 10.1016/j.joen.2012.11.041. Epub 2013 Jan 27.
PubMed 23683284Banchs F, Trope M. Revascularization of immature permanent teeth with apical periodontitis: new treatment protocol? J Endod. 2004 Apr;30(4):196-200. doi: 10.1097/00004770-200404000-00003.
PubMed 15085044Jitaru S, Hodisan I, Timis L, Lucian A, Bud M. The use of bioceramics in endodontics - literature review. Clujul Med. 2016;89(4):470-473. doi: 10.15386/cjmed-612. Epub 2016 Oct 20.
PubMed 27857514Alobaid AS, Cortes LM, Lo J, Nguyen TT, Albert J, Abu-Melha AS, Lin LM, Gibbs JL. Radiographic and clinical outcomes of the treatment of immature permanent teeth by revascularization or apexification: a pilot retrospective cohort study. J Endod. 2014 Aug;40(8):1063-70. doi: 10.1016/j.joen.2014.02.016. Epub 2014 Jun 13.
PubMed 25069909Torabinejad M, Pitt Ford TR. Root end filling materials: a review. Endod Dent Traumatol. 1996 Aug;12(4):161-78. doi: 10.1111/j.1600-9657.1996.tb00510.x.
PubMed 9028180
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Bioceramic Root Repair Versus Bio MTA in Revascularization of Immature Young Permenant Teeth.
- ClinicalTrials.gov ID
- NCT06630156
- Acronym / sponsor ID
- Treatment of immature teeth
- Keywords
- Revascularization, Bio MTA, Total Fill biocearmic root repair material
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 21 Aug 2022 (actual)
- Primary completion
- 21 Nov 2024 (estimated)
- Study completion
- 21 Dec 2024 (estimated)
- First posted
- 8 Oct 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.
The present clinical study wasdirected to evaluate bioceramic root repair material versus Bio MTA in Revascularization of Immature Young Permenant Teeth through:
- Clinical evaluation including: Pain, swelling, sinus or fistula, mobility and crown discoloration.
- Radiographic evaluation including: Root lengthening, continued thickening of the dentinal walls, apical closure and regression of the peri-apical lesion.
Detailed description
In a young permanent tooth with pulp necrosis and apical pathosis, routine endodontic treatment may not be possible due to the immature apex it possesses. Newer methods based on the principles of revascularization and regeneration have been tried and found to be much better than the traditional methods of apexification since it helps in physiological root maturation, unlike traditional methods which result in only artificial barrier formation without root lengthening.
Revascularization is a new treatment method for immature necrotic permanent teeth. Indeed, it would provide, after treatment, a vital tooth that would be able to complete its root maturation. Three key requirements for a successful revascularization are: (a) Root canal disinfection; (b) matrix inside the canal for growth of tissue (scaffold); and (c) a tight seal access filling.
Bio MTA was introduced to overcome some of the drawbacks of MTA such as handling properties and long setting time. Bio MTA has a faster setting time with good handling characteristics and biological properties. Calcium silicate based restorative cements were formulated using different calcium compounds such as calcium hydroxide, calcium oxide, calcium phosphate, calcium sulfate, calcium silicate, and calcium carbonate in combination with zirconium. The mixed cement comprises water-soluble calcium and phosphate and immediately forms hydroxyapatite during and after setting.
A Total Fill biocearmic root repair material which is calcium silicate-based cement was developed with excellent handling properties as it is supplied in premixed packages (putty) that do not require preparation before use. It is mainly composed of calcium silicate, monobasic calcium phosphate, calcium hydroxide, and zirconium oxide. It has antibacterial and antifungal activities. It is claimed that the material is biocompatible with human periodontal tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients selected in this study were randomly divided into 2 groups: 1. Group A: 14 teeth were disinfected by triple paste and treated by Bio-MTA. 2. Group A: 14 teeth were disinfected by triple paste and treated by a Total Fill biocearmic root repair.
| Arm | Type | Receives |
|---|---|---|
| Bio-MTA revascularization | Active comparator | Biological: Revascularization of Immature Young Permenant Teeth |
| Total Fill biocearmic root repair material revascularization | Active comparator | Biological: Revascularization of Immature Young Permenant Teeth |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child with an age ranged from (7-12) year from both sexes.
- Patient and parent cooperation.
- Non vital immature permanent teeth indicated for endodontic treatment as a result of pulp necrosis.
- Patient is not taking antibiotic and has not taken for the past 2 weeks.
- Restorable teeth.
Key exclusion criteria (6 listed)
- Patients allergic to any drug used in this RCT.
- Patients with any systemic disease that would contraindicate pulp therapy (rheumatic fever, infective endocarditis, leukemia, corticosteroid therapy and immune suppressed children).
- Tooth with vital pulp or complete root formation.
- Teeth with draining sinus or periodontal weak mobile teeth.
- Teeth with internal or external root resorption.
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 |
|---|---|---|
| Revascularization of Immature Young Permenant TeethAn access cavity was prepared under rubber dam, isolation, root canal system disinfection was done without mechanical instrumentation. Subsequently, triple antibiotic paste was placed into the apical portion of the canal and filled to just below the CEJ. The access cavity was temporarily restored with glass ionomer. 4 weeks later, after reopening of the access, the antibiotic paste was gently flushed out of the canal with sterile normal saline. The root canal system was irrigated. A sterile #35 K-file will be introduced into the canal beyond the apical foramen using a push and pull motion to provoke bleeding from the periapical tissue. After bleeding control and formation of fresh blood clot, 3 mm of Bio (MTA) will be placed in Group A, 3 mm of Total Fill biocearmic root repair material will be placed in Group B after a moist cotton pellet was placed over the capping material and the access cavity will be sealed with G C | Biological | Bio-MTA revascularization, Total Fill biocearmic root repair material revascularization |
Primary outcome
radiographic parameters
Time frame: baseline, 3, 6, and 12 months after treatment
continued root lengthening and thickening of the dentinal walls in mm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 17368324Murray PE, Garcia-Godoy F, Hargreaves KM. Regenerative endodontics: a review of current status and a call for action. J Endod. 2007 Apr;33(4):377-90. doi: 10.1016/j.joen.2006.09.013. Epub 2007 Feb 20.
- Background: PubMed 22627612Kim DS, Park HJ, Yeom JH, Seo JS, Ryu GJ, Park KH, Shin SI, Kim SY. Long-term follow-ups of revascularized immature necrotic teeth: three case reports. Int J Oral Sci. 2012 Jun;4(2):109-13. doi: 10.1038/ijos.2012.23.
- Background: PubMed 19801227Bose R, Nummikoski P, Hargreaves K. A retrospective evaluation of radiographic outcomes in immature teeth with necrotic root canal systems treated with regenerative endodontic procedures. J Endod. 2009 Oct;35(10):1343-9. doi: 10.1016/j.joen.2009.06.021. Epub 2009 Aug 15.
- Background: PubMed 11471648Shuping GB, Orstavik D, Sigurdsson A, Trope M. Reduction of intracanal bacteria using nickel-titanium rotary instrumentation and various medications. J Endod. 2000 Dec;26(12):751-5. doi: 10.1097/00004770-200012000-00022.
- Background: PubMed 22077958Chen MY, Chen KL, Chen CA, Tayebaty F, Rosenberg PA, Lin LM. Responses of immature permanent teeth with infected necrotic pulp tissue and apical periodontitis/abscess to revascularization procedures. Int Endod J. 2012 Mar;45(3):294-305. doi: 10.1111/j.1365-2591.2011.01978.x. Epub 2011 Nov 14.
- Background: PubMed 27617375Asgary S, Fazlyab M, Nosrat A. Regenerative Endodontic Treatment versus Apical Plug in Immature Teeth: Three-Year Follow-Up. J Clin Pediatr Dent. 2016;40(5):356-60. doi: 10.17796/1053-4628-40.5.356.
- Background: PubMed 23683284Chuensombat S, Khemaleelakul S, Chattipakorn S, Srisuwan T. Cytotoxic effects and antibacterial efficacy of a 3-antibiotic combination: an in vitro study. J Endod. 2013 Jun;39(6):813-9. doi: 10.1016/j.joen.2012.11.041. Epub 2013 Jan 27.
- Background: PubMed 15085044Banchs F, Trope M. Revascularization of immature permanent teeth with apical periodontitis: new treatment protocol? J Endod. 2004 Apr;30(4):196-200. doi: 10.1097/00004770-200404000-00003.
- Background: PubMed 27857514Jitaru S, Hodisan I, Timis L, Lucian A, Bud M. The use of bioceramics in endodontics - literature review. Clujul Med. 2016;89(4):470-473. doi: 10.15386/cjmed-612. Epub 2016 Oct 20.
- Background: PubMed 25069909Alobaid AS, Cortes LM, Lo J, Nguyen TT, Albert J, Abu-Melha AS, Lin LM, Gibbs JL. Radiographic and clinical outcomes of the treatment of immature permanent teeth by revascularization or apexification: a pilot retrospective cohort study. J Endod. 2014 Aug;40(8):1063-70. doi: 10.1016/j.joen.2014.02.016. Epub 2014 Jun 13.
- Background: PubMed 9028180Torabinejad M, Pitt Ford TR. Root end filling materials: a review. Endod Dent Traumatol. 1996 Aug;12(4):161-78. doi: 10.1111/j.1600-9657.1996.tb00510.x.
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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.
Reda Mohammed Elsayed, assistant lecturer principal investigator
Faculty of Dental Medicine, Al- Azhar University, Assuit, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Revascularization of Immature Young Permenant Teeth in people with Revascularization of Immature Young Permenant Teeth, run by Al-Azhar 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 6 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2024. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
radiographic parameters (time frame: baseline, 3, 6, and 12 months after treatment). 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 NCT06630156, which also lists 11 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 15 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.