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PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth

1 de novembro de 2026 atualizado por: Ipek Eraslan Akyuz, TC Erciyes University

PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth: A Clinical Trial

This clinical trial will compare platelet-rich plasma (PRP)-assisted regenerative endodontic treatment with conventional root canal treatment in mature permanent teeth with pulp necrosis and apical periodontitis.

Ten participants will be included, and each participant will contribute two eligible single-rooted, single-canal teeth. Within each participant, one tooth will receive PRP-assisted regenerative endodontic treatment and the other tooth will receive conventional root canal treatment.

The primary objective is to compare radiographic periapical healing between the two treatments at 12 months. Secondary outcomes will include postoperative pain, analgesic use, clinical signs and symptoms, pulp sensibility, treatment success, tooth survival, and adverse events. Clinical and radiographic follow-up will be performed at 6, 12, and 24 months.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This prospective, single-center, within-patient clinical trial will evaluate platelet-rich plasma (PRP)-assisted regenerative endodontic treatment compared with conventional root canal treatment in mature permanent teeth with pulp necrosis and apical periodontitis.

Ten participants will be enrolled, and each participant will contribute two eligible mature, single-rooted, single-canal permanent teeth. Within each participant, one tooth will receive PRP-assisted regenerative endodontic treatment and the paired tooth will receive conventional root canal treatment. This paired design allows each participant to serve as his or her own control and is intended to reduce the influence of interindividual variability.

Both study teeth will undergo standardized chemomechanical preparation, irrigation, intracanal medication with calcium hydroxide, and a second treatment visit. In the PRP-assisted regenerative treatment arm, autologous PRP will be prepared from venous blood and introduced into the root canal after controlled apical stimulation. A bioceramic coronal barrier will then be placed, followed by definitive coronal restoration. In the conventional root canal treatment arm, the canal will be obturated with gutta-percha and bioceramic sealer and definitively restored.

Postoperative pain will be recorded separately for each study tooth at 6, 12, 24, and 48 hours and on days 3 through 7. Analgesic use will also be recorded.

Clinical and radiographic follow-up will be performed at 6, 12, and 24 months. The primary outcome will be radiographic periapical healing at 12 months, expressed as the percentage reduction in standardized periapical lesion area relative to baseline. Secondary outcomes will include postoperative pain trajectory, analgesic consumption, Periapical Index scores, complete radiographic healing, clinical success, cold and electric pulp sensibility responses, tooth survival, and adverse events.

Radiographic assessments will be performed using standardized periapical radiographs. Outcome assessors will be blinded to treatment allocation, and radiographic measurements will be performed by calibrated examiners.

Tipo de estudo

Intervencional

Inscrição (Estimado)

10

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Turquia (Türkiye)
    • Kayseri
      • Kayseri, Kayseri, Turquia (Türkiye), 38039
        • Erciyes University Faculty of Dentistry
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 45 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Age 18-45 years.
  • ASA physical status I or II.
  • Two restorable mature permanent teeth suitable for paired allocation.
  • Single-rooted, single-canal anatomy.
  • Closed apices and completed root development.
  • Diagnosis of pulp necrosis.
  • Radiographic evidence of apical periodontitis.
  • Periapical Index (PAI) score ≥3 for both study teeth.
  • Periapical radiolucency ≥5 mm at its greatest radiographic dimension for both study teeth.
  • Periodontal probing depth ≤3 mm and absence of advanced periodontal disease.
  • Absence of pathological mobility.
  • Adequate coronal tooth structure for definitive restoration and feasibility of rubber-dam isolation.
  • Ability and willingness to complete postoperative pain records and attend 6-, 12-, and 24-month follow-up visits.

Exclusion Criteria:

  • Previous root canal treatment or previous endodontic surgery in either study tooth.
  • More than one root or more than one root canal.
  • Open apex, developmental anomaly, internal or external root resorption, root fracture, or suspected vertical root fracture.
  • Severe canal curvature or anatomy incompatible with standardized instrumentation.
  • Non-restorable tooth or inability to obtain adequate isolation.
  • Periodontal attachment loss or periodontal probing depth >3 mm.
  • Pregnancy or breastfeeding.
  • Systemic disease or medication likely to substantially alter inflammation, coagulation, pain perception, or healing.
  • Use of analgesics, anti-inflammatory drugs, systemic corticosteroids, or antibiotics within the predefined preoperative period.
  • Inability to comply with postoperative or long-term follow-up.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: PRP-Assisted Regenerative Endodontic Treatment

Participants will receive PRP-assisted regenerative endodontic treatment in one eligible mature necrotic tooth. After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, autologous platelet-rich plasma will be prepared from venous blood and introduced into the root canal at the second visit after controlled apical stimulation. A Biodentine coronal barrier will then be placed, followed by definitive resin composite restoration.
Procedimento: PRP-Assisted Regenerative Endodontic Treatment

After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, autologous platelet-rich plasma is prepared from venous blood and introduced into the root canal at the second visit after controlled apical stimulation. A Biodentine coronal barrier is placed, followed by definitive resin composite restoration.
Comparador Ativo: Conventional Root Canal Treatment

Participants will receive conventional root canal treatment in the paired eligible mature necrotic tooth. After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, the canal will be obturated at the second visit with gutta-percha and NeoSealer Flo bioceramic sealer using the cold lateral condensation technique. The access cavity will then be definitively restored with resin composite.
Procedimento: Conventional Root Canal Treatment

After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, the root canal is obturated at the second visit with gutta-percha and NeoSealer Flo bioceramic sealer using the cold lateral condensation technique. The access cavity is then definitively restored with resin composite.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage Reduction in Periapical Lesion Area
Prazo: Baseline to 12 months

Periapical lesion area will be measured on standardized digital periapical radiographs by calibrated blinded examiners using validated image-analysis software. Percentage lesion reduction will be calculated as [(baseline lesion area - 12-month lesion area) / baseline lesion area] × 100. Higher percentage values indicate greater radiographic healing.
Baseline to 12 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Postoperative Pain Intensity
Prazo: 6, 12, 24, and 48 hours and days 3, 4, 5, 6, and 7 after treatment

Postoperative pain will be recorded separately for each study tooth using a 100-mm visual analogue scale (VAS), where 0 represents no pain and 100 represents the worst imaginable pain. Participants will record tooth-specific pain scores at each predefined postoperative time point.
6, 12, 24, and 48 hours and days 3, 4, 5, 6, and 7 after treatment
Analgesic Consumption
Prazo: From treatment through postoperative day 7

Analgesic use will be recorded for each study tooth during the postoperative follow-up period. Participants will record the time and number of analgesic doses taken. Ibuprofen 400 mg will be recommended when required, with paracetamol 500 mg used when ibuprofen is contraindicated.
From treatment through postoperative day 7
Periapical Index Score
Prazo: 6, 12, and 24 months

Periapical healing will be assessed using the Periapical Index (PAI) on standardized periapical radiographs. PAI scores will be determined by calibrated blinded examiners at each follow-up visit.
6, 12, and 24 months
Complete Radiographic Healing
Prazo: 6, 12, and 24 months

Complete radiographic healing will be assessed on standardized periapical radiographs by calibrated blinded examiners. Complete healing will be recorded when the periapical radiolucency has resolved and no radiographic evidence of progressive periapical disease is present.
6, 12, and 24 months
Clinical Success
Prazo: 6, 12, and 24 months

Clinical success will be defined as a functional tooth without spontaneous pain, tenderness to percussion or palpation, swelling, sinus tract, or evidence of progressive periapical disease. Teeth requiring nonsurgical retreatment, endodontic surgery, extraction, or another intervention because of persistent endodontic disease will be classified as failures.
6, 12, and 24 months
Pulp Sensibility Response
Prazo: 6, 12, and 24 months

Pulp sensibility will be assessed using cold testing and electric pulp testing at follow-up visits. A positive response to either sensibility test will be recorded for each study tooth.
6, 12, and 24 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

TC Erciyes University

Investigadores

  • Investigador principal: ipek eraslan akyüz, DDS, TC Erciyes University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de janeiro de 2027

Conclusão Primária (Estimado)

1 de junho de 2028

Conclusão do estudo (Estimado)

1 de junho de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

1 de novembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de novembro de 2026

Primeira postagem (Real)

5 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ERU-ENDO-PRPREP-RCT-2026

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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