Outcome of Pulp Revascularization of Necrotic Mature Permanent Teeth Using Platelet-rich Fibrin

NCT06347640 | Recruiting

• 1 other identifier: KingAbdullahUH2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Regenerative endodontic procedures are intended to replace damaged tooth structures, including dentine and root structures, in addition to cells of the pulp-dentine complex. This treatment modality have been tested on immature necrotic teeth because they are anticipated to have a greater chance of pulp tissue regeneration. However, it has been recently suggested for treating fully formed mature necrotic permanent teeth with closed apices since the conventional root canal treatment yielded many drawbacks. A number of studies have evaluated the regeneration outcomes of using blood clot as a scaffold. However, there are limited studies in the literature on using other scaffolds such as platelet-rich fibrin (PRF). This clinical study will evaluate clinically and radiographically the effectiveness of PRF versus induced bleeding in treating mature necrotic teeth. Fifty patients with necrotic mature teeth with periapical lesions will be invited to participate in this study. Teeth will be treated using calcium hydroxide as intracanal medicament then using PRF (n=25) and blood clot (n=25) as scaffold. All teeth will be sealed coronally using NeoMTA Plus™. Treated teeth will be assessed clinically and radiographically using 2D periapical radiographs. The reported clinical and radiographic outcomes will be compared using SPSS.

Conditions

Pulp Revascularization

Outcome Measures

Primary Outcomes (1)

• Complete healing

  Assess clinically and radiographically absence of symptoms and signs And evidence for continuation of root development after regeneration procedures

  treated teeth will be evaluated from start of intervention up to 100 months

Secondary Outcomes (1)

• regain the pulp sensibility

  pulp sensibility will be evaluated one year after treatment

Study Arms (2)

Induced bleeding group

ACTIVE COMPARATOR

revascularization of mature necrotic permanent teeth treated by induced bleeding though apex of the tooth

Biological: induced bleeding

Platelet-rich fibrin (PRF) group

EXPERIMENTAL

revascularization of mature necrotic permanent teeth treated using platelet-rich fibrin (PRF)

Biological: plasma rich fibrin

Interventions

induced bleeding BIOLOGICAL

revascularization of tooth is achieved by induced bleeding

Induced bleeding group

plasma rich fibrin BIOLOGICAL

revascularization of tooth is achieved by plasma rich fibrin

Platelet-rich fibrin (PRF) group

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Anterior or posterior mature tooth diagnosed with necrotic pulp in the presence of a periapical lesion,
• Pulp space is not needed for post and core restoration.
• Patients are not allergic to the medicaments necessary to complete the procedure.

You may not qualify if:

• Medically compromised patient.
• Patient with generalized chronic periodontitis.
• Teeth with previous root canal treatment.
• Periodontal pocket larger than 3mm.
• Teeth with vertical fractures
• Non-restorable teeth

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Jordan University of Science and Technology

Irbid, POBOX 3030, Jordan

RECRUITING

Study Officials

• Lama Awawdeh

  Jordan University of Science and Technology

  STUDY CHAIR

Central Study Contacts

Lama Awawdeh, MSc, PhD

CONTACT

0795412954; lawawdeh@just.edu.jo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: April 4, 2024
• Study Start: April 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)