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Digitized Assessment for the Survival of Mature Anterior Teeth With Periapical Lesion After One Step Regenerative Approach Using Different Asepsis Maneuvers (RCT)

Primary Purpose

Dental Pulp Necrosis, Dental Pulp Disease, Dental Pulp; Degeneration

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Disinfection
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pulp Necrosis

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Patients who are free from any physical or mental handicapping condition with no underlying systemic diseases.
  • Non-pregnant females
  • Single canalled anterior teeth.
  • Patients having non-vital, mature, anterior teeth, radiographic evidence of periapical lesion.
  • Positive patient/Guardian compliance for participation in the study.

Exclusion criteria:

  • Any known sensitivity or adverse reactions to medicaments or pharmaceuticals necessary to complete the trial.
  • Non-restorable coronal portion of teeth involved in the trial.
  • Vital teeth
  • immature teeth
  • Traumatized teeth
  • Radiographic evidence of external or internal root resorption.
  • Any criterion, not mentioned in the inclusion criteria

Sites / Locations

  • Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Laser Group

Nano irrigant Group

Conventional irrigation protocol group

Arm Description

Disinfection using biostimulating LASER

Disinfection using Nano irrigant

disinfection using normal irrigation protocols

Outcomes

Primary Outcome Measures

Periapical Healing
Bone healing

Secondary Outcome Measures

Survival of tooth
tooth survival after procedure
Sensitivity
assess sensitivity using pulp tester

Full Information

First Posted
August 28, 2018
Last Updated
February 19, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03652129
Brief Title
Digitized Assessment for the Survival of Mature Anterior Teeth With Periapical Lesion After One Step Regenerative Approach Using Different Asepsis Maneuvers
Acronym
RCT
Official Title
Digitized Assessment for the Survival of Mature Anterior Teeth With Periapical Lesion After One Step Regenerative Approach Using Different Asepsis Maneuvers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 22, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Trial is designed to allow revascularization and tissue engineering in necrotic teeth with peripical lesion in a single visit approach. different disinfection protocols is used to ensure that adequate disinfection of root canals is achieved to allow stem cells to differentiate and proliferate generating pulp like tissue and turning back tooth to live with periapical healing of resorbed bone.
Detailed Description
Preservation of the natural dentition had always been a primary objective in endodontic practice. When the pulp is diseased or requires removal for restorative reasons, it is replaced with an artificial filling material during conventional root canal treatment. Root canal treatment has lots of controversies, starting with weakening of remaining tooth structure, affecting the tooth survival. Also Root canal treated teeth are considered to be weaker than vital tooth, requiring the placement of a post and core, which itself is doubtful whether it increases fracture resistance of the tooth or it weakens it.1 The most important controversy is that the survival of affected pulp is hindered by the conventional root canal treatment2. Thus a new treatment approach was introduced utilizing the body ability to regenerate, called Pulp Regeneration. Regeneration was first introduced in the dental field as a solution for immature apex treatment, as it is very difficult to treat them using the conventional root canal treatment3 American Dental Association adopted the tissue engineering concept and pulp regeneration in 20114. Regeneration was focused on the treatment of immature necrotic teeth so as to allow root completion, improving both the functionality and durability of the affected tooth. Depending on the success of pulp regeneration in treating immature teeth, ambitious dentists started to look forward on treating mature teeth as a substitution to the conventional root canal treatment. 5 A shift to tissue engineering took place. Utilizing a blood clot in the affected tooth with immature roots was very beneficial, as it acts as a scaffold for the migration of stem cells and morphogens to allow regeneration .6 On the other hand, lots of clinicians were very doubtful about treating mature teeth with the same protocol, as the small apical foramen might not provide a good portal for the entry of stem cells and growth factors, which in turn is very important for the success of pulp regeneration.7 These doubts encouraged researchers to look for an alternative to the stem cells other than the apical papilla, from this concept the idea for using an alternative source of stem cells and growth factors as platelet rich plasma (PRP) emerged. The use of Platelet Rich Plasma (PRP) as a potentially ideal scaffold for regenerative endodontic therapy has been documented8. However, the use of bovine thrombin for the activation of PRP has been an issue of controversy, as it requires non autologous anticoagulant known to hinder the process of pulp regeneration 9. This led to the development of the second generation, Platelet concentrate known as Choukroun's Platelet Rich Fibrin (PRF) which is totally autologous in nature. Platelet rich fibrin (PRF) was very promising, but it is debatable whether to use PRP or PRF10. One protocol of the regenerative approach is the use of Antibiotic paste as intra canal medicament in a 2 step procedures, due to the world wide trend of limitation of the use of antibiotics systemically and locally the assessment of the outcome of single visit regenerative approach is mandatory, and because the main limitation for such intervention is adequate disinfection of root canal assessment of different asepsis maneuvers is also of great importance since literature and evidence based information lack any studies assessing such techniques. The clinician at the end of this study must determine which disinfection protocol allows for more survival of tooth, revitalization of the affected mature tooth and faster healing of periapical lesion following one step regenerative approach. Healing will be measured using digital radiography and cone beam computed topography11. Repair of the tooth neural innervation will be tested by electric pulp tester12.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Necrosis, Dental Pulp Disease, Dental Pulp; Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser Group
Arm Type
Experimental
Arm Description
Disinfection using biostimulating LASER
Arm Title
Nano irrigant Group
Arm Type
Experimental
Arm Description
Disinfection using Nano irrigant
Arm Title
Conventional irrigation protocol group
Arm Type
Active Comparator
Arm Description
disinfection using normal irrigation protocols
Intervention Type
Procedure
Intervention Name(s)
Disinfection
Intervention Description
Disinfection maneuver using LASER and nano irrigant
Primary Outcome Measure Information:
Title
Periapical Healing
Description
Bone healing
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Survival of tooth
Description
tooth survival after procedure
Time Frame
1 year
Title
Sensitivity
Description
assess sensitivity using pulp tester
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Patients who are free from any physical or mental handicapping condition with no underlying systemic diseases. Non-pregnant females Single canalled anterior teeth. Patients having non-vital, mature, anterior teeth, radiographic evidence of periapical lesion. Positive patient/Guardian compliance for participation in the study. Exclusion criteria: Any known sensitivity or adverse reactions to medicaments or pharmaceuticals necessary to complete the trial. Non-restorable coronal portion of teeth involved in the trial. Vital teeth immature teeth Traumatized teeth Radiographic evidence of external or internal root resorption. Any criterion, not mentioned in the inclusion criteria
Facility Information:
Facility Name
Faculty of Dentistry
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Digitized Assessment for the Survival of Mature Anterior Teeth With Periapical Lesion After One Step Regenerative Approach Using Different Asepsis Maneuvers

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