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

NCT ID: NCT06347640

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2027-12-01

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.

Detailed Description

The regeneration procedures have been focused on immature teeth since there is a need for a treatment modality to give a chance for root maturation, apical closure, and root canal walls thickening which cannot be achieved by other procedures like apexification. Immature teeth have a greater chance of pulp tissue regeneration. The presence of an open apex will allow the stem cells from the apical papilla to migrate into root canals.

In the case of mature teeth, the presence of complex anatomy causes difficulties in disinfection. In addition, the presence of narrow apical pathway for stem cells migration makes them weak candidates for regeneration. However, the use of conventional root canal therapy has many drawbacks.

A retrospective study reported that even though conventional root canal therapy had prolonged tooth survival, pulp removal still led to tooth loss in comparison with teeth with normal pulp. Losing the pulp means reduced levels of proprioception in addition to the innate immunity that is disallowed after root canal therapy leaving remaining bacterial colonies in the root canal system. By applying regeneration techniques in mature teeth, we have the chance to avoid the previously mentioned drawbacks of root canal therapy and restore the neurovascular system with immune cells that will act as a line of defense mechanism against microbial attacks.

A few studies and case reports have investigated the effectiveness of regeneration procedures using blood clot as a scaffold in treating mature necrotic teeth. The idea that led toward the use of platelet concentrates as a scaffold was that concentrated platelets and growth factors collected in plasma solutions could promote local healing. Comparing it to blood clot, it increased cell proliferation over time due to its increased concentration of growth factors.

Given the drawbacks of conventional root canal treatment and limited studies in the literature on using other treatment modalities in treating mature necrotic teeth, hence the need for a randomized clinical trial with large sample size and long follow-ups emerge. This clinical study will evaluate clinically and radiographically the effectiveness of PRF versus induced bleeding in treating mature necrotic teeth.

Conditions

Pulp Revascularization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Induced bleeding group

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

Group Type: ACTIVE_COMPARATOR

induced bleeding

Intervention Type: BIOLOGICAL

revascularization of tooth is achieved by induced bleeding

Platelet-rich fibrin (PRF) group

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

Group Type: EXPERIMENTAL

plasma rich fibrin

Intervention Type: BIOLOGICAL

revascularization of tooth is achieved by plasma rich fibrin

Interventions

induced bleeding

revascularization of tooth is achieved by induced bleeding

Intervention Type: BIOLOGICAL

plasma rich fibrin

revascularization of tooth is achieved by plasma rich fibrin

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Anterior or posterior mature tooth diagnosed with necrotic pulp in the presence of a periapical lesion,

2. Pulp space is not needed for post and core restoration.

3. Patients are not allergic to the medicaments necessary to complete the procedure.

Exclusion Criteria

1. Medically compromised patient.

2. Patient with generalized chronic periodontitis.

3. Teeth with previous root canal treatment.

4. Periodontal pocket larger than 3mm.

5. Teeth with vertical fractures

6. Non-restorable teeth

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jordan University of Science and Technology

OTHER

Sponsor Role: collaborator

King Abdullah University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lama Awawdeh

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lama Awawdeh

Role: STUDY_CHAIR

Jordan University of Science and Technology

Locations

Jordan University of Science and Technology

Irbid, , Jordan

Site Status: RECRUITING

Countries

Jordan

Central Contacts

Lama Awawdeh, MSc, PhD

Role: CONTACT

lawawdeh@just.edu.jo

0795412954

Facility Contacts

Lama A Awawdeh

Role: primary

lawawdeh@hotmail.com

0795412954

Other Identifiers

KingAbdullahUH2

Identifier Type: -

Identifier Source: org_study_id