Clinical trial NCT06347640: Outcome of Pulp Revascularization of Necrotic Mature Permanent Teeth Using Platelet-rich Fibrin
Official title: The Outcome of Pulp Revascularization of Necrotic Mature Permanent Teeth With Periapical Lesion Using Platelet-rich Fibrin Versus Induced Bleeding: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulp Revascularization
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
Collaborators: name: Jordan University of Science and Technology
First posted: 2024-04-04
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Complete healing
timeFrame: treated teeth will be evaluated from start of intervention up to 100 months
Secondary outcomes:
measure: regain the pulp sensibility
timeFrame: pulp sensibility will be evaluated one year after treatment
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Lama Awawdeh
role: STUDY_CHAIR
References: