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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06347640
Enrollment
50
Registered
2024-04-04
Start date
2023-04-01
Completion date
2027-12-01
Last updated
2024-04-04

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

Conditions

Pulp Revascularization

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.

Interventions

BIOLOGICALinduced bleeding

revascularization of tooth is achieved by induced bleeding

BIOLOGICALplasma rich fibrin

revascularization of tooth is achieved by plasma rich fibrin

Sponsors

Jordan University of Science and Technology
CollaboratorOTHER
King Abdullah University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Complete healingtreated teeth will be evaluated from start of intervention up to 100 monthsAssess clinically and radiographically absence of symptoms and signs And evidence for continuation of root development after regeneration procedures

Secondary

MeasureTime frameDescription
regain the pulp sensibilitypulp sensibility will be evaluated one year after treatmentasses pulp sensibility using cold test

Countries

Jordan

Contacts

Primary ContactLama Awawdeh, MSc, PhD
lawawdeh@just.edu.jo0795412954

Outcome results

None listed

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