Revascularization of Immature Anterior Necrotic Teeth

Status Not yet recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03504332
Study type	Interventional
Source	Cairo University
Contact	Reem Wahby, MD
Phone	0020112652778
Email	reem.wahby@dentistry.cu.edu.eg
Status	Not yet recruiting
Phase	Phase 3
Start date	June 2018
Completion date	September 2020

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT04035083` - Laser Activated Irrigation Versus Passive Ultrasonic Irrigation	N/A
Not yet recruiting	`NCT05728346` - The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization	N/A
Completed	`NCT04638972` - Accuracy of Apex Locators in Primary Teeth
Completed	`NCT05181813` - Treatment of Infected Pulp in Primary Teeth With a Mixture of Calcium Hydroxide and Gingerols	N/A
Completed	`NCT04545307` - Transplantation of Allogeneic MSC in Patients With Pulp Necrosis and Chronic Apical Periodontitis	Phase 2/Phase 3
Recruiting	`NCT06142799` - Influence of Moment of Restoration in Pain After a Root Canal Treatment	N/A
Completed	`NCT06227533` - Comparison Between Two Regenerative Scaffolds	N/A
Not yet recruiting	`NCT05305417` - Cell-free Autologous Regenerative Endodontics Treatment for Teeth With Periapical Lesions (CARETT)	N/A
Completed	`NCT04390854` - Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth	Phase 2
Completed	`NCT03804450` - Magnetic Resonance Imaging (MRI) of Pulp Regeneration	Phase 2
Completed	`NCT05057325` - Post Operative Pain Assessment After Pulpectomy of Primary Molars With Two Different Rotary Systems	N/A
Completed	`NCT06129643` - Post-operative Pain After Laser Root Canal Treatment of Necrotic Teeth With Apical Periodontitis	Phase 2
Completed	`NCT05964686` - The Efficacy of Laser in Root Canal Disinfection	Phase 2
Terminated	`NCT04533074` - Microbiological Evaluation of Single Versus Multiple Visits Regeneration Using MALDI-TOF Mass Spectrometry	Phase 2
Active, not recruiting	`NCT06256250` - Assessment of Post-operative Pain After Different Instrumentation Techniques in Pulpectomy Treatment of Primary Molars	N/A
Completed	`NCT06173648` - Histopathological Evaluation of the Periodontal Ligament Subjected to Laser Ablation.	N/A
Not yet recruiting	`NCT05230797` - Zincoxide-propolis vs Zincoxide-eugenol Pulpectomy	Early Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.