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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03504332
Other study ID # regenerative endodontics
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received April 5, 2018
Last updated April 12, 2018
Start date June 2018
Est. completion date September 2020

Study information

Verified date April 2018
Source Cairo University
Contact Reem Wahby, MD
Phone 0020112652778
Email reem.wahby@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 56
Est. completion date September 2020
Est. primary completion date June 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 15 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
intracanal 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Binary outcome (present/ absent). Assessed by asking the patient baseline.
Primary Change in pain Binary outcome (present/ absent). Assessed by asking the patient. at 6 and 12 months
Secondary Pain on percussion Binary outcome (present/absent).Assessed by using back of the dental mirror. baseline and for 1 year follow up
Secondary Swelling Binary outcome (present/absent). Assessed by visual inspection of labial vestibules. baseline and for 1 year follow up
Secondary Sinus or fistula Binary outcome (present/absent). Assessed by visual inspection of labial vestibules. baseline and for 1 year follow up
Secondary Root Lengthening Will be evaluated radiographically using DIGORA software. Unit of measurement will be mm. baseline and for 1 year follow up
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