Revascularization of Immature Anterior Necrotic Teeth
Primary Purpose
Pulp Necroses
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
intracanal disinfection in revascularization
Sponsored by
About this trial
This is an interventional treatment trial for Pulp Necroses focused on measuring immature teeth, revascularization
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Calcium Hydroxide in revascularization
Di-antibiotic paste in revascularization
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Pain
Binary outcome (present/ absent). Assessed by asking the patient
Change in pain
Binary outcome (present/ absent). Assessed by asking the patient.
Secondary Outcome Measures
Pain on percussion
Binary outcome (present/absent).Assessed by using back of the dental mirror.
Swelling
Binary outcome (present/absent). Assessed by visual inspection of labial vestibules.
Sinus or fistula
Binary outcome (present/absent). Assessed by visual inspection of labial vestibules.
Root Lengthening
Will be evaluated radiographically using DIGORA software. Unit of measurement will be mm.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03504332
Brief Title
Revascularization of Immature Anterior Necrotic Teeth
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2018 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Necroses
Keywords
immature teeth, revascularization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Calcium Hydroxide in revascularization
Arm Type
Experimental
Arm Description
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.
Arm Title
Di-antibiotic paste in revascularization
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
intracanal disinfection in revascularization
Intervention Description
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 Measure Information:
Title
Pain
Description
Binary outcome (present/ absent). Assessed by asking the patient
Time Frame
baseline.
Title
Change in pain
Description
Binary outcome (present/ absent). Assessed by asking the patient.
Time Frame
at 6 and 12 months
Secondary Outcome Measure Information:
Title
Pain on percussion
Description
Binary outcome (present/absent).Assessed by using back of the dental mirror.
Time Frame
baseline and for 1 year follow up
Title
Swelling
Description
Binary outcome (present/absent). Assessed by visual inspection of labial vestibules.
Time Frame
baseline and for 1 year follow up
Title
Sinus or fistula
Description
Binary outcome (present/absent). Assessed by visual inspection of labial vestibules.
Time Frame
baseline and for 1 year follow up
Title
Root Lengthening
Description
Will be evaluated radiographically using DIGORA software. Unit of measurement will be mm.
Time Frame
baseline and for 1 year follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reem Wahby, MD
Phone
0020112652778
Email
reem.wahby@dentistry.cu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Revascularization of Immature Anterior Necrotic Teeth
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