Microbiological Evaluation of Single Versus Multiple Visits Regeneration Using MALDI-TOF Mass Spectrometry (A Randomized Controlled Clinical Trial)
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Tooth mobility
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Single-visit regeneration protocol
Intervention: Single-visit regeneration protocol (Biological)
Multiple-visits regeneration protocol
Intervention: Multiple-visits regeneration protocol (Biological)
Outcomes
Primary Outcomes
Tooth mobility
Time Frame: up to 12 months
4. Mobility will be recorded according to Grace \& Smales Mobility Index * Grade 0: No apparent mobility * Grade 1: Perceptible mobility \<1mm in buccolingual direction * Grade 2: 1mm\< but \<2mm * Grade 3: 2mm\< or depressibility in the socket
Microbiological assessment
Time Frame: 24 hours
The presence or absence of reduction in types of micro-organisms in root canals
Tooth vitality
Time Frame: up to 12 months
Tooth vitality will be assessed by sensibility testing using thermal stimulation, binary (yes or no).
Root lengthening
Time Frame: up to 12 months
The root length will be measured as a straight line from the CEJ to the radiographic apex of the tooth. This will be measured on both periapical radiography and Cone-beam computed tomographic (CBCT) in millimeters.
Root thickening
Time Frame: up to 12 months
The dentinal wall thickness for both the preoperative and recall images will be measured at the level of the apical one third of the preoperative root canal length measured from the CEJ. The root canal width and the pulp space will be measured at this level, and the remaining dentin thickness will be calculated by subtracting the pulp space from the root canal width.
Healing of periapical lesions
Time Frame: up to 12 months
Periapical index score (PAI) will be used for identification of apical periodontitis on both periapical radiography and Cone-beam computed tomographic (CBCT). It is a 6-point (0 -5) scoring system with 2 additional variables, expansion of cortical bone and destruction of cortical bone.The PAI will be determined by the largest extension of the lesion on periapical radiography and CBCT scans in 3 dimensions: axial, sagittal, and coronal. * Score 0 Intact periapical bone structures. * Score 1 Diameter of periapical radiolucency "0.5-1 mm. * Score 2 Diameter of periapical radiolucency "1-2 mm. * Score 3 Diameter of periapical radiolucency "2-4 mm. * Score 4 Diameter of periapical radiolucency "4-8 mm. * Score 5 Diameter of periapical radiolucency "8 mm. * Score (n)# E: Expansion of periapical cortical bone. * Score (n)# D: Destruction of periapical cortical bone.
Secondary Outcomes
No secondary outcomes reported
Investigators
Nourhan M.Aly
Assistant Lecturer of Dental Public Health
University of Alexandria