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Assessment of Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Using Two Revascularization Protocols. (In Vivo Study)

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ClinicalTrials.gov Identifier: NCT04158232
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Ali, Minia University

Brief Summary:
Regenerative endodontic procedures have been used to successfully treat human mature permanent teeth with necrotic pulps and apical periodontitis. Many researchers have begun to apply regenerative endodontic procedures to mature teeth in adult patients. Several clinical case reports have shown complete resolution of signs and symptoms of pulp necrosis in mature teeth, even those with large periapical lesions, as well as signs of pulp canal obliteration. thevaim of this study is To assess the regenerative potential of mature permanent teeth with necrotic pulps with platelet-rich fibrin (PRF) and blood clot using radiographic and clinical methods.

Condition or disease Intervention/treatment Phase
Apical Periodontitis Other: Method Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Using Two Revascularization Protocols. (In Vivo Study)
Estimated Study Start Date : November 2, 2019
Estimated Primary Completion Date : September 2, 2020
Estimated Study Completion Date : November 2, 2020

Arm Intervention/treatment
Active Comparator: Blood clotting protocol for pulp regeneration
pulp regeneration for mature teeth using blood clotting protocol
Other: Method
treatment of mature teeth with apical periodontitis

Experimental: platelet rich fibrin for pulp regeneration
pulp regeneration for mature teeth using platelet rich fibrin (PRF)
Other: Method
treatment of mature teeth with apical periodontitis




Primary Outcome Measures :
  1. clinical success [ Time Frame: 9 months ]
    pulp vitality testing using electric pulp tester which detect response of pulp to electric current

  2. radiographic success [ Time Frame: 9 months ]
    healing of apical periodontitis by detecting change in apical radiolucency and absences of apical bone resorption



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Ages Eligible for Study:   11 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with mature teeth.
  • Patients with periapical periodontitis.
  • Maxillary anterior teeth only will be involved.
  • Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
  • 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.
  • Unrestorable teeth.
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Responsible Party: Ahmed Ali, assistant lecturer, Minia University
ClinicalTrials.gov Identifier: NCT04158232    
Other Study ID Numbers: 306
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019

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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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Periodontitis
Periapical Periodontitis
Dental Pulp Necrosis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Necrosis
Pathologic Processes
Periapical Diseases
Jaw Diseases
Dental Pulp Diseases
Tooth Diseases