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

The Outcome of Pulp Revascularization of Necrotic Mature Permanent Teeth With Periapical Lesion Using Platelet-rich Fibrin Versus Induced Bleeding: Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pulp Revascularization
• Intervention / Treatment: Biological: induced bleeding; Biological: plasma rich fibrin

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lama Awawdeh, MSc, PhD; Phone Number: 0795412954; Email: lawawdeh@just.edu.jo

Study Locations

• Jordan
  • Irbid, Jordan, POBOX 3030
    • Recruiting
    • Jordan University of Science and Technology
    • Contact: Lama A Awawdeh; Phone Number: 0795412954; Email: lawawdeh@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Induced bleeding group; revascularization of mature necrotic permanent teeth treated by induced bleeding though apex of the tooth	Biological: induced bleeding; revascularization of tooth is achieved by induced bleeding
Experimental: Platelet-rich fibrin (PRF) group; revascularization of mature necrotic permanent teeth treated using platelet-rich fibrin (PRF)	Biological: plasma rich fibrin; revascularization of tooth is achieved by plasma rich fibrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
regain the pulp sensibility	asses pulp sensibility using cold test	pulp sensibility will be evaluated one year after treatment

Collaborators and Investigators

• Sponsor: King Abdullah University Hospital
• Collaborators: Jordan University of Science and Technology
• Investigators: Study Chair: Lama Awawdeh, Jordan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 23, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis
• Other Study ID Numbers: KingAbdullahUH2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No