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

March 13, 2022 updated by: Nourhan M.Aly

Microbiological Evaluation of Single Versus Multiple Visits Regeneration Using MALDI-TOF Mass Spectrometry (A Randomized Controlled Clinical Trial)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21512
        • Faculty of Dentistry, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-visit regeneration protocol
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.
Active Comparator: Multiple-visits regeneration protocol
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nourhan M.Aly

Collaborators

Alexandria University

Investigators

  • Study Director: Rania M ElBackly, PhD, Faculty of Dentistry, Alexandria University, Egypt
  • Principal Investigator: Pervine H. Sharaf, M.Sc, Faculty of Dentistry, Alexandria University, Egypt
  • Study Chair: Raef A Sherif, PhD, Faculty of Dentistry, Alexandria University, Egypt
  • Study Chair: Ashraf M Zaazou, PhD, Faculty of Dentistry, Alexandria University, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2018

Primary Completion (Actual)

March 10, 2021

Study Completion (Actual)

March 15, 2021

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

August 27, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 13, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MALDI-TOF MS regeneration

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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