Using Three Different Final Irrigants and Showing Their Effects on the Success of Revascularization

July 18, 2018 updated by: Maha Ahmed Nassar, Cairo University

Assessment of Implementing Nano-technology in the Irrigation Protocol of One Step Revascularization For Necrotic Mature Teeth

this study will assess different irrigating materials on the success revascularization of necrotic mature teeth associated with PRF.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Nano-propolis and Propolis will be used as final endodontic irrigants and will be compared to saline in Revascularization of necrotic mature teeth.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

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

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mature teeth.
  • teeth with periapical periodontitis.
  • Maxillary anterior teeth
  • Patients should be free from any systemic disease
  • Patients who will agree to the consent and will commit to follow-up period.

Exclusion Criteria:

  • Patients with immature roots.
  • Patients with any systemic disease that may affect normal healing.
  • Patients with swelling. .Pregnant females. .Patients who could/would not participate in a 1-year follow-up. .Patients with fistula. .Patients with old age. .Teeth with periodontal involvement. .Teeth with vertical root fractures. .Non-restorable teeth.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: propolis
natural antibacterial, anti-inflammatory irrigation solution
Drug: Propolis
Using propolis as a final irrigation in revascularization
Other Names:
  • natural irrigant
Experimental: Nano-propolis
natural antibacterial, anti-inflammatory irrigation solution
Drug: Nano-propolis
Using Nano-propolis as a final irrigation in revasculariztion
Other Names:
  • Natural irrigant
Active Comparator: saline
sodium chloride irrigation solution
Drug: saline
Using saline as a final irrigation in revasculariztion
Other Names:
  • sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative pain: Visual analogue scale
Time Frame: 1 year
post-operative pain evaluated using Visual analogue scale , 0 no pain, 10 severe pain.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
periapical healing
Time Frame: 1 year
evaluated radiographically
1 year
sensitivity
Time Frame: 1 year
electric pulp tester
1 year
survival
Time Frame: 1 year
clinical evaluation
1 year

Collaborators and Investigators

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

Sponsor

Cairo University

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 (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

June 26, 2018

First Submitted That Met QC Criteria

July 18, 2018

First Posted (Actual)

July 19, 2018

Study Record Updates

Last Update Posted (Actual)

July 19, 2018

Last Update Submitted That Met QC Criteria

July 18, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD_CU_2018_05_29

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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