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

Phase 2

Terminated

• Conditions: Pulp Necroses; Tooth, Nonvital
• Interventions: Biological: Multiple-visits regeneration protocol; Biological: Single-visit regeneration protocol

• Registration Number: NCT04533074
• Lead Sponsor: Nourhan M.Aly

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 Timeline

• Study Start: 2018-08-23
• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-08-31
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-13
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple-visits regeneration protocol	Multiple-visits regeneration protocol	-
Single-visit regeneration protocol	Single-visit regeneration protocol	-

Primary Outcome Measures

Name	Time	Method
Microbiological assessment	24 hours	The presence or absence of reduction in types of micro-organisms in root canals
Tooth mobility	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
Tooth vitality	up to 12 months	Tooth vitality will be assessed by sensibility testing using thermal stimulation, binary (yes or no).
Root lengthening	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	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	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt