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Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04390854
Enrollment
30
Registered
2020-05-18
Start date
2018-07-06
Completion date
2020-08-30
Last updated
2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulp Necroses

Keywords

Regenerative endodontics, Open apex, Immature necrotic teeth

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.

Interventions

BIOLOGICALBlood clot scaffold

Bleeding will be induced in the canal by passing a size 30 sterile K-file 3 mm beyond the apex with the goal of having the entire canal filled with blood to the level of the cemento-enamel junction. Bleeding will be stopped just below the cemento enamel junction. Biodentine will be placed approximately 3-4 mm below the cementoenamel junction.

BIOLOGICALBlood clot scaffold combined with PRF

Platelet-rich fibrin will be prepared by drawing the patient blood into a 10mL test tube without the addition of an anticoagulant. To prevent the blood from coagulating after coming in contact with the glass tube, it will be centrifuged immediately using a table top centrifuge\*\* at 400 g force for 12 minutes. Then platelet-rich fibrin membrane will be placed into the canal space to a level 3 mm below the cemento-enamel junction using hand plugger following the induction of apical bleeding by passing a number 30 sterile hand file 3 mm beyond the apex of the tooth. Biodentine cap will be placed over the platelet-rich fibrin scaffold.

Sponsors

Alexandria University
CollaboratorOTHER
Nourhan M.Aly
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The radiographic specialist and the statistician will be blinded to treatment group

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Subjective pain assessment1 monthThe 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 pulp vitality1 monthPulp vitality will be assessed using thermal and electric pulp sensibility tests
Assessment of root development1 monthContinued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
Assessment of the size of periapical radiolucency1 monthSize of the lesion will be assessed using the periapical index score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026