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
1 other identifier
interventional
56
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2018
CompletedFirst Posted
Study publicly available on registry
April 20, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedApril 20, 2018
April 1, 2018
2 years
April 5, 2018
April 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pain
Binary outcome (present/ absent). Assessed by asking the patient
baseline.
Change in pain
Binary outcome (present/ absent). Assessed by asking the patient.
at 6 and 12 months
Secondary Outcomes (4)
Pain on percussion
baseline and for 1 year follow up
Swelling
baseline and for 1 year follow up
Sinus or fistula
baseline and for 1 year follow up
Root Lengthening
baseline and for 1 year follow up
Study Arms (2)
Calcium Hydroxide in revascularization
EXPERIMENTALRevascularization 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 COMPARATORRevascularization 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.
Interventions
a procedure to create vital cells in the pulp space of immature teeth which enables thickening of the dentinal walls of the root.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Children Allergic to antibiotics to be used in the study.
- unooperative children.
- Laxative injuries.
- Compromised remaining tooth structure.
- internal or external root resorption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 5, 2018
First Posted
April 20, 2018
Study Start
June 1, 2018
Primary Completion
June 1, 2020
Study Completion
September 1, 2020
Last Updated
April 20, 2018
Record last verified: 2018-04