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

NCT04533074 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-03-29

No results posted yet for this study

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.

Conditions

  • Pulp Necroses
  • Tooth, Nonvital

Interventions

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.

Sponsors & Collaborators

  • Alexandria University

    collaborator OTHER

  • Nourhan M.Aly

    lead OTHER

Principal Investigators

  • Pervine H. Sharaf, M.Sc · Faculty of Dentistry, Alexandria University, Egypt

  • Raef A Sherif, PhD · Faculty of Dentistry, Alexandria University, Egypt

  • Ashraf M Zaazou, PhD · Faculty of Dentistry, Alexandria University, Egypt

  • Rania M ElBackly, PhD · Faculty of Dentistry, Alexandria University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-23
Primary Completion
2021-03-10
Completion
2021-03-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04533074 on ClinicalTrials.gov