NCT04533074

Microbiological Evaluation of Single Versus Multiple Visits Regeneration Using MALDI-TOF Mass Spectrometry

Microbiological Evaluation of Single Versus Multiple Visits Regeneration Using MALDI-TOF Mass Spectrometry (A Randomized Controlled Clinical Trial)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Nourhan M.Aly · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Aim of the study is to assess canal disinfection using matrix assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) in single visit and multiple visit regeneration protocols, and to assess clinical and radiographic outcomes of single visit and multiple visit regeneration protocols.

Detailed description

Thirty patients with necrotic immature permanent teeth showing periapical lesions will be randomly divided in two groups: group (1) single visit regeneration and group (2) multiple visits regeneration protocol, in which calcium hydroxide will be applied for one week or more according to resolution of signs and symptoms. Dentin debris collected on a file will be taken as microbiologic sample to be cultured and examined by MALDI-TOF MS. This will be performed after the access cavity preparation and after irrigation in both groups, these samples will be labelled A and B, respectively. In group (2) there will be a third sample labeled C which will be taken after the removal of the intra canal calcium hydroxide.

Conditions

• Pulp Necroses
• Tooth, Nonvital

Interventions

Type	Name	Description
BIOLOGICAL	Single-visit regeneration protocol	In a single visit, access opening, minimal instrumentation and irrigation will be done. After irrigation and drying, the apical tissue will be irritated to evoke bleeding in the canal, using a precurved K-file 2mm past the apical foramen, with the goal of having the entire canal filled with blood to the level of the cemento-enamel junction. The bleeding will be stopped at a level that allows for 3-4 mm of restorative material. Three millimeters of Biodentine will then be placed directly over the blood clot of each tooth. A 3-4 mm layer of glass ionomer is flowed gently over the capping material. Each access cavity will be restored using composite resin.
BIOLOGICAL	Multiple-visits regeneration protocol	In the first visit, access opening, minimal instrumentation and irrigation will be done. The root canal will be then dried and filled with calcium hydroxide paste. The tooth will be sealed with an intermediate restorative material (IRM), and the patient will be dismissed for 1-4weeks. In the second appointment, response to initial treatment will be assessed and the steps will be repeated if symptoms are persistent. If there are no symptoms, evoking bleeding to the level of the cemento-enamel junction will be done followed by Biodentine application over the blood clot with final glass ionomer and composite restorations.

Timeline

• Start date: 2018-08-23
• Primary completion: 2021-03-10
• Completion: 2021-03-15
• First posted: 2020-08-31
• Last updated: 2022-03-29

Locations

1 site across 1 country: Egypt