NCT03652129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

August 28, 2018

Last Update Submit

February 19, 2020

Conditions

Dental Pulp NecrosisDental Pulp DiseaseDental Pulp; Degeneration

Outcome Measures

Primary Outcomes (1)

  • Periapical Healing

    Bone healing

    1 year

Secondary Outcomes (2)

  • Survival of tooth

    1 year

  • Sensitivity

    1 year

Study Arms (3)

Laser Group

EXPERIMENTAL

Disinfection using biostimulating LASER

Procedure: Disinfection

Nano irrigant Group

EXPERIMENTAL

Disinfection using Nano irrigant

Procedure: Disinfection

Conventional irrigation protocol group

ACTIVE COMPARATOR

disinfection using normal irrigation protocols

Procedure: Disinfection

Interventions

DisinfectionPROCEDURE

Disinfection maneuver using LASER and nano irrigant

Conventional irrigation protocol groupLaser GroupNano irrigant Group

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Pulp NecrosisDental Pulp Diseases

Interventions

Disinfection

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SterilizationInfection ControlCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Lecturer

Study Record Dates

First Submitted

August 28, 2018

First Posted

August 29, 2018

Study Start

August 22, 2018

Primary Completion

December 1, 2019

Study Completion

February 1, 2020

Last Updated

February 21, 2020

Record last verified: 2020-02

Locations

EG(1)