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

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ClinicalTrials.gov Identifier: NCT03591172
Recruitment Status : Unknown
Verified May 2018 by Maha Ahmed Nassar, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Maha Ahmed Nassar, Cairo University

Study Description
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Brief Summary:
this study will assess different irrigating materials on the success revascularization of necrotic mature teeth associated with PRF.

Condition or disease Intervention/treatment Phase
Post-operative Pain Drug: Propolis Drug: Nano-propolis Drug: saline Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Assessment of Implementing Nano-technology in the Irrigation Protocol of One Step Revascularization For Necrotic Mature Teeth
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: propolis
natural antibacterial, anti-inflammatory irrigation solution
 Drug: Propolis
Using propolis as a final irrigation in revascularization
Other Name: natural irrigant
Experimental: Nano-propolis
natural antibacterial, anti-inflammatory irrigation solution
 Drug: Nano-propolis
Using Nano-propolis as a final irrigation in revasculariztion
Other Name: Natural irrigant
Active Comparator: saline
sodium chloride irrigation solution
 Drug: saline
Using saline as a final irrigation in revasculariztion
Other Name: sodium chloride


Outcome Measures
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Primary Outcome Measures :
  1. post-operative pain: Visual analogue scale [ Time Frame: 1 year ]
    post-operative pain evaluated using Visual analogue scale , 0 no pain, 10 severe pain.


Secondary Outcome Measures :
  1. periapical healing [ Time Frame: 1 year ]
    evaluated radiographically

  2. sensitivity [ Time Frame: 1 year ]
    electric pulp tester

  3. survival [ Time Frame: 1 year ]
    clinical evaluation


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Maha Ahmed Nassar, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03591172    
Other Study ID Numbers: CEBD_CU_2018_05_29
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
 Neurologic Manifestations
Propolis
Anti-Infective Agents