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Clinical Trials/NCT04390854
NCT04390854
Completed
Phase 2

Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth (A Randomized Controlled Clinical Trial)

Nourhan M.Aly1 site in 1 country30 target enrollmentJuly 6, 2018
ConditionsPulp Necroses

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Pulp Necroses
Sponsor
Nourhan M.Aly
Enrollment
30
Locations
1
Primary Endpoint
Assessment of pulp vitality
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The aim of the present study is to assess clinically and radio-graphically the regenerative potential of immature permanent teeth with necrotic pulp using blood clot and Platelet rich fibrin scaffolds.

Detailed Description

30 immature necrotic permanent teeth in patients will be allocated and divided into two groups. Group 1 will be treated by regenerative procedure using blood clot as a scaffold and Group 2 will be treated with regenerative procedures using combined blood clot and Platelet rich fibrin as a scaffold.

Registry
clinicaltrials.gov
Start Date
July 6, 2018
End Date
August 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nourhan M.Aly
Responsible Party
Sponsor Investigator
Principal Investigator

Nourhan M.Aly

Teaching Assistant of Dental Public Health and Statistician

University of Alexandria

Eligibility Criteria

Inclusion Criteria

  • Necrotic incisors with immature roots
  • Pulp space not needed for post and core.
  • The patient has to be free from any coagulation disorders, with normal platelets count.
  • Good oral hygiene
  • Cooperative patient

Exclusion Criteria

  • Internal or external root resorption.
  • Root fracture and/or alveolar fracture.
  • Previous root canal treatment.
  • Medically compromised patients
  • Uncooperative patient

Outcomes

Primary Outcomes

Assessment of pulp vitality

Time Frame: 12 months

Pulp vitality will be assessed using thermal and electric pulp sensibility tests

Assessment of the size of periapical radiolucency

Time Frame: 12 months

Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).

Subjective pain assessment

Time Frame: 12 months

The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain

Assessment of root development

Time Frame: 12 months

Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth

Study Sites (1)

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