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Revascularization of Immature Anterior Necrotic Teeth

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03504332
Enrollment
56
Registered
2018-04-20
Start date
2018-06-30
Completion date
2020-09-30
Last updated
2018-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulp Necroses

Keywords

immature teeth, revascularization

Brief 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.

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.

Interventions

PROCEDUREintracanal disinfection in revascularization

a procedure to create vital cells in the pulp space of immature teeth which enables thickening of the dentinal walls of the root.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* Children Allergic to antibiotics to be used in the study. * unooperative children. * Laxative injuries. * Compromised remaining tooth structure. * internal or external root resorption

Design outcomes

Primary

MeasureTime frameDescription
Painbaseline.Binary outcome (present/ absent). Assessed by asking the patient
Change in painat 6 and 12 monthsBinary outcome (present/ absent). Assessed by asking the patient.

Secondary

MeasureTime frameDescription
Pain on percussionbaseline and for 1 year follow upBinary outcome (present/absent).Assessed by using back of the dental mirror.
Swellingbaseline and for 1 year follow upBinary outcome (present/absent). Assessed by visual inspection of labial vestibules.
Sinus or fistulabaseline and for 1 year follow upBinary outcome (present/absent). Assessed by visual inspection of labial vestibules.
Root Lengtheningbaseline and for 1 year follow upWill be evaluated radiographically using DIGORA software. Unit of measurement will be mm.

Contacts

Primary ContactReem Wahby, MD
reem.wahby@dentistry.cu.edu.eg0020112652778

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026