ClinicalTrials.Veeva

Menu

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

N

Nourhan M.Aly

Status and phase

Terminated
Phase 2

Conditions

Pulp Necroses
Tooth, Nonvital

Treatments

Biological: Single-visit regeneration protocol
Biological: Multiple-visits regeneration protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT04533074
MALDI-TOF MS regeneration

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

8 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

16 participants in 2 patient groups

Single-visit regeneration protocol
Experimental group
Treatment:
Biological: Single-visit regeneration protocol
Multiple-visits regeneration protocol
Active Comparator group
Treatment:
Biological: Multiple-visits regeneration protocol

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems