A Phase 3 interventional study of intracanal disinfection in revascularization in Pulp Necroses, sponsored by Cairo University. Status unknown. Open to participants aged 7 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-20.
Sponsored by Cairo University · Phase 3, Interventional, and Treatment
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.
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.
149 studies on the registry are indexed under Dental Pulp Necrosis; 39 are open to participants now.
This study's planned enrollment of 56 is above the median of 44 across 139 interventional studies indexed under Dental Pulp Necrosis.
Browse Dental Pulp Necrosis studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
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
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.
Pain
Binary outcome (present/ absent). Assessed by asking the patient
Time frame: baseline.
Change in pain
Binary outcome (present/ absent). Assessed by asking the patient.
Time frame: at 6 and 12 months
Pain on percussion
Binary outcome (present/absent).Assessed by using back of the dental mirror.
Time frame: baseline and for 1 year follow up
Swelling
Binary outcome (present/absent). Assessed by visual inspection of labial vestibules.
Time frame: baseline and for 1 year follow up
Sinus or fistula
Binary outcome (present/absent). Assessed by visual inspection of labial vestibules.
Time frame: baseline and for 1 year follow up
Root Lengthening
Will be evaluated radiographically using DIGORA software. Unit of measurement will be mm.
Time frame: baseline and for 1 year follow up
No study locations are listed for this record.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Cairo University