Pulp NecrosesPhase 3NCT03504332
Revascularization of Immature Anterior Necrotic Teeth
A Phase 3 study testing intracanal disinfection in revascularization in people with Pulp Necroses, run by Cairo University.
Trial summary
The object of this study is to compare the effect of Calcium Hydroxide and Di-antibiotic paste as intracanal disinfectants in the 1st visit of revascularization of necrotic immature permanent anterior teeth. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Necroses
- What is being tested?
- intracanal disinfection in revascularization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Sep 2020
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Immature anterior teeth with open apices.
- Necrotic teeth (regardless the cause of pulpal involvement: Caries, trauma or congenital anomalies).
- Children free from any systemic diseases that may interfere with the normal healing process.
Who cannot join
- Children Allergic to antibiotics to be used in the study.
- unooperative children.
- Laxative injuries.
- Compromised remaining tooth structure.
- internal or external root resorption
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical and Radiographic Evaluation of Calcium Hydroxide and Bi-antibiotic Paste as Anti-microbial Dressing in Revascularization of Non Vital Immature Permanent Anterior Teeth: A Randomized Clinical Trial
The object of this study is to compare the effect of Calcium Hydroxide and Di-antibiotic paste as intracanal disinfectants in the 1st visit of revascularization of necrotic immature permanent anterior teeth.
Read the detailed description
Dental trauma is common in children and it is the main cause of loss of pulp vitality in immature permanent anterior teeth with prevalence rate of 11% and about of 27% of traumatized anterior teeth are left untreated.
Dentists face many challenges during the treatment of infected immature permanent teeth. This is mainly due to the thin dentinal walls of the root and blunderbuss apices that make these teeth susceptible to fracture during and after treatment.
Traditionally, Calcium Hydroxide apexification has been the only method for managing these cases.. however, it was found that this technique caused additional reduction in root strength due to the long-term application of Calcium Hydroxide which may end in fracture of the tooth. The time needed for complete apexification using Calcium Hydroxide was reported to be variable ranging from 5 to 20 months, with failure rate 0f 30% . Therefore, this technique is no longer recommended for the treatment of such cases.
A recently proposed technique for the treatment of immature necrotic permanent teeth is revascularization regenerative endodontic therapy (RET). It is a biologically based technique that allow the continuation of root development and thickening of dentinal walls. This is achieved through proper disinfection o the root canal system, creation of scaffold and perfect coronal seal.
For proper disinfection of the root canal system, antibiotic paste was applied as intracanal dressing for 2-3 weeks. However, the recent recommendations by the European society of Endodontology advices the use of Calcium Hydroxide as intracanal medication instead of intracanal antibiotics. This is because of some concerns regarding the use of antibiotics which include: cytotoxicity to stem cells needed for the revascularization process, risk of antibiotic resistance and the risk of sensitization. Calcium Hydroxide on the other hand is widely used as intracanal disinfectant and some studies were found supporting its use in the revascularization technique, [9, 10]. However, the data available is not sufficient regarding the effectiveness of Calcium Hydroxide in revascularization of necrotic pulp.
Besides, more trials are needed to evaluate the clinical effectiveness of RET in management of immature necrotic permanent teeth as the evidence of using this technique is still weak.
- Conditions
- Pulp Necroses
- Being tested
- intracanal disinfection in revascularization
- Keywords
- immature teeth, 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.
intracanal disinfection in revascularizationProcedure or surgery
a procedure to create vital cells in the pulp space of immature teeth which enables thickening of the dentinal walls of the root.
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxide in revascularization | Experimental | Revascularization of necrotic anterior teeth: canals disinfection step. Pure Calcium Hydroxide powder mixed with saline will be placed as intra-canal medication in the 1st visit of dental pulp revascularization. Receives: Procedure: intracanal disinfection in revascularization |
| Di-antibiotic paste in revascularization | Active comparator | Revascularization of necrotic anterior teeth: canals disinfection step. Mix 1:1 ciprofloxacin: metronidazole to a final concentration of 0.1 mg/ml, placed as intra-canal medication in the 1st visit of dental pulp revascularization. Receives: Procedure: intracanal disinfection in revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Binary outcome (present/ absent). Assessed by asking the patient
Measured: baseline.
Change in pain
Binary outcome (present/ absent). Assessed by asking the patient.
Measured: at 6 and 12 months
Secondary outcomes (4)
Pain on percussion
Binary outcome (present/absent).Assessed by using back of the dental mirror.
Measured: baseline and for 1 year follow up
Swelling
Binary outcome (present/absent). Assessed by visual inspection of labial vestibules.
Measured: baseline and for 1 year follow up
Sinus or fistula
Binary outcome (present/absent). Assessed by visual inspection of labial vestibules.
Measured: baseline and for 1 year follow up
Root Lengthening
Will be evaluated radiographically using DIGORA software. Unit of measurement will be mm.
Measured: baseline and for 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study startJun 2018 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp NecrosesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Mohamed Fouad Wahby, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504332
- Sponsor's protocol ID
- regenerative endodontics
- Status last verified
- Apr 2018
- First submitted
- 5 Apr 2018
- Last updated
- 20 Apr 2018
- 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 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Calcium Hydroxide and Bi-antibiotic Paste as Anti-microbial Dressing in Revascularization of Non Vital Immature Permanent Anterior Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03504332
- Acronym / sponsor ID
- regenerative endodontics
- Conditions
- Pulp Necroses
- Keywords
- immature teeth, revascularization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 20 Apr 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.
The object of this study is to compare the effect of Calcium Hydroxide and Di-antibiotic paste as intracanal disinfectants in the 1st visit of revascularization of necrotic immature permanent anterior teeth.
Detailed description
Dental trauma is common in children and it is the main cause of loss of pulp vitality in immature permanent anterior teeth with prevalence rate of 11% and about of 27% of traumatized anterior teeth are left untreated.
Dentists face many challenges during the treatment of infected immature permanent teeth. This is mainly due to the thin dentinal walls of the root and blunderbuss apices that make these teeth susceptible to fracture during and after treatment.
Traditionally, Calcium Hydroxide apexification has been the only method for managing these cases.. however, it was found that this technique caused additional reduction in root strength due to the long-term application of Calcium Hydroxide which may end in fracture of the tooth. The time needed for complete apexification using Calcium Hydroxide was reported to be variable ranging from 5 to 20 months, with failure rate 0f 30% . Therefore, this technique is no longer recommended for the treatment of such cases.
A recently proposed technique for the treatment of immature necrotic permanent teeth is revascularization regenerative endodontic therapy (RET). It is a biologically based technique that allow the continuation of root development and thickening of dentinal walls. This is achieved through proper disinfection o the root canal system, creation of scaffold and perfect coronal seal.
For proper disinfection of the root canal system, antibiotic paste was applied as intracanal dressing for 2-3 weeks. However, the recent recommendations by the European society of Endodontology advices the use of Calcium Hydroxide as intracanal medication instead of intracanal antibiotics. This is because of some concerns regarding the use of antibiotics which include: cytotoxicity to stem cells needed for the revascularization process, risk of antibiotic resistance and the risk of sensitization. Calcium Hydroxide on the other hand is widely used as intracanal disinfectant and some studies were found supporting its use in the revascularization technique, [9, 10]. However, the data available is not sufficient regarding the effectiveness of Calcium Hydroxide in revascularization of necrotic pulp.
Besides, more trials are needed to evaluate the clinical effectiveness of RET in management of immature necrotic permanent teeth as the evidence of using this technique is still weak.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium Hydroxide in revascularization | Experimental | Procedure: intracanal disinfection in revascularizationRevascularization of necrotic anterior teeth: canals disinfection step. Pure Calcium Hydroxide powder mixed with saline will be placed as intra-canal medication in the 1st visit of dental pulp revascularization. |
| Di-antibiotic paste in revascularization | Active comparator | Procedure: intracanal disinfection in revascularizationRevascularization of necrotic anterior teeth: canals disinfection step. Mix 1:1 ciprofloxacin: metronidazole to a final concentration of 0.1 mg/ml, placed as intra-canal medication in the 1st visit of dental pulp revascularization. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Immature anterior teeth with open apices.
- Necrotic teeth (regardless the cause of pulpal involvement: Caries, trauma or congenital anomalies).
- Children free from any systemic diseases that may interfere with the normal healing process.
Key exclusion criteria (5 listed)
- Children Allergic to antibiotics to be used in the study.
- unooperative children.
- Laxative injuries.
- Compromised remaining tooth structure.
- 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 |
|---|---|---|
| intracanal disinfection in revascularizationa procedure to create vital cells in the pulp space of immature teeth which enables thickening of the dentinal walls of the root. | Procedure or surgery | Calcium Hydroxide in revascularization, Di-antibiotic paste in revascularization |
Primary outcome
Pain
Time frame: baseline.
Binary outcome (present/ absent). Assessed by asking the patient
Change in pain
Time frame: at 6 and 12 months
Binary outcome (present/ absent). Assessed by asking the patient.
4 secondary outcomes
Pain on percussion
Time frame: baseline and for 1 year follow up
Swelling
Time frame: baseline and for 1 year follow up
Sinus or fistula
Time frame: baseline and for 1 year follow up
Root Lengthening
Time frame: baseline and for 1 year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intracanal disinfection in revascularization in people with Pulp Necroses, 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 3 inclusion and 5 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 Apr 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Reem Wahby, MD (0020112652778, reem.wahby@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: baseline.). 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?
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 Apr 2018.