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Clinical Trial Summary

This study evaluates success rate of non vital mature anterior teeth with periapical lesion treated by regenerative endodontic protocol in single visit versus two visit technique.

Patients are randomized into two groups where treatment will be done either in one visit including access, disinfection, placing platelet rich plasma as scaffold and restoration or two visit protocol involving access, disinfection and placing calcium hydroxide as intracanal medicament in first visit followed by a second visit after 3 weeks involving reopening of the tooth, removing intracanal medicament and placing platelet rich plasma as scaffold then restoration. Success rate is defined as absence of subjective signs and symptoms along with healing of periapical lesion


Clinical Trial Description

Title: Evaluation of Success Rate of Non Vital Mature Anterior Teeth with Periapical Lesion Following Single versus Two Visit Regenerative Treatment Protocol (A Randomized Clinical Trial) Regenerative endodontics can be defined as biologically based procedures designed to replace damaged structures, including dentin and root structures, as well as cells of the pulp-dentin complex.

The majority of endodontic patients are adults, thus the application of the tissue engineering concept to mature teeth could provide a biological treatment modality instead of the conventional one. In fact, several advantages were reported about regenerative procedures in well developed mature teeth. Reconstitution of the neurovascular system in root canals by pulp regeneration will provide pulp tissues with an immune system, which will function as the first line of defense against microbial challenge. Moreover, restoration of pulp dentine complex will protect the tooth during loading and mastication.

Different treatment protocols for pulp regeneration were reported in the literature regarding irrigation (type, concentration and time), intracanal medication, pulpal space barrier, incorporation and lack of scaffolds (blood clot, PRP,PRF, collagen) as well as recall visits.

Rationale for conducting the research and choice of comparators:

Multiple visits protocol has been the commonly used technique in regenerative endodontic procedures. It involves the placement of intracanal medicaments between visits (calcium hydroxide and triple antibiotic paste) which have many drawbacks such as difficulty in removal, tooth discoloration, weakening of the root and tooth loss.

Completing revascularization in one visit has many advantages. First, it reduces the chance of additional bacterial contamination of the space. Second, a single revascularization protocol may overcome the problem of poor patient compliance and reduce the number of appointments needed. Third, it can help to combat potential injury of the tooth and tooth discoloration Unfortunately, up till the moment it is not clear which protocol is the most effective. Thus randomized clinical trials are required to provide plausible answers to this question In the present research the recent single visit regenerative treatment for necrotic mature teeth will be compared to the conventionally used two visit one ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03717337
Study type Interventional
Source Cairo University
Contact
Status Not yet recruiting
Phase N/A
Start date January 1, 2019
Completion date December 1, 2020

See also
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Recruiting NCT04313010 - Effectiveness of Regenerative Endodontics Therapy for Single-rooted Mature Permanent Tooth With Pulp Necrosis N/A
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Completed NCT03589560 - Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Anterior Teeth N/A
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Completed NCT03849222 - Evaluation the Effect of Using of Apical Matrix With Apexification Procedure on Apical Healing of Necrotic Immature Teeth Phase 2/Phase 3
Completed NCT00881491 - Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste Phase 0