Clinical trial NCT04533074: Microbiological Evaluation of Single Versus Multiple Visits Regeneration Using MALDI-TOF Mass Spectrometry
Official title: Microbiological Evaluation of Single Versus Multiple Visits Regeneration Using MALDI-TOF Mass Spectrometry (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pulp Necroses
Tooth, Nonvital
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-08-31
Enrollment: 16
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Immature permanent upper anterior teeth.
* Necrotic teeth confirmed by sensibility test.
* Teeth with periapical lesions confirmed by periapical radiograph using paralleling device.

Exclusion Criteria:

* Teeth with orthodontic wires or brackets.
* Patient with history of allergy to any medication.
* Patient with history of bleeding disorders.
* Patient with medical illness or taking medications.

Primary outcomes:
measure: Microbiological assessment
timeFrame: 24 hours
measure: Tooth vitality
timeFrame: up to 12 months
measure: Tooth mobility
timeFrame: up to 12 months
measure: Healing of periapical lesions
timeFrame: up to 12 months
measure: Root lengthening
timeFrame: up to 12 months
measure: Root thickening
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Pervine H. Sharaf, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Raef A Sherif, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Ashraf M Zaazou, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Rania M ElBackly, PhD
role: STUDY_DIRECTOR
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