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Revascularization of Immature Anterior Necrotic Teeth

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ClinicalTrials.gov Identifier: NCT03504332
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Reem Mohamed Fouad Wahby, Cairo University

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.

Condition or disease Intervention/treatment Phase
Pulp Necroses Procedure: intracanal disinfection in revascularization Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Experimental: Calcium Hydroxide in revascularization
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.
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.

Active Comparator: Di-antibiotic paste in revascularization
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.
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.




Primary Outcome Measures :
  1. Pain [ Time Frame: baseline. ]
    Binary outcome (present/ absent). Assessed by asking the patient

  2. Change in pain [ Time Frame: at 6 and 12 months ]
    Binary outcome (present/ absent). Assessed by asking the patient.


Secondary Outcome Measures :
  1. Pain on percussion [ Time Frame: baseline and for 1 year follow up ]
    Binary outcome (present/absent).Assessed by using back of the dental mirror.

  2. Swelling [ Time Frame: baseline and for 1 year follow up ]
    Binary outcome (present/absent). Assessed by visual inspection of labial vestibules.

  3. Sinus or fistula [ Time Frame: baseline and for 1 year follow up ]
    Binary outcome (present/absent). Assessed by visual inspection of labial vestibules.

  4. Root Lengthening [ Time Frame: baseline and for 1 year follow up ]
    Will be evaluated radiographically using DIGORA software. Unit of measurement will be mm.



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Ages Eligible for Study:   7 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504332


Contacts
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Contact: Reem Wahby, MD 0020112652778 reem.wahby@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University

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Responsible Party: Reem Mohamed Fouad Wahby, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03504332     History of Changes
Other Study ID Numbers: regenerative endodontics
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Reem Mohamed Fouad Wahby, Cairo University:
immature teeth, revascularization

Additional relevant MeSH terms:
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Necrosis
Dental Pulp Necrosis
Pathologic Processes
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs