Comparison of Autologous Tooth and Bovine Xenograft in Periodontal Healing After Mandibular Third Molar Extraction
Evaluation of Changes in Probing Depth Following Surgical Extraction of Mandibular Third Molars Using Particulated Autologous Tooth vs. Particulated Bovine Xenograft vs. Blood Clot: A Randomized Clinical Trial
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This study investigates the healing of periodontal defects on the distal surface of the second lower molars after the surgical extraction of impacted third molars. Specifically, it compares the effectiveness of autologous tooth graft particles (derived from the extracted third molar) with bovine xenograft particles, using blood clot healing as a control.
Lower third molars are the most frequently impacted teeth, and their extraction can sometimes lead to or worsen periodontal defects on the adjacent second molar. Previous studies have shown positive outcomes using various bone regeneration materials; however, autologous tooth grafts have recently emerged as a biocompatible, osteoconductive, and osteoinductive alternative with promising results. Despite this, there are no clinical studies directly comparing autologous tooth grafts and bovine xenografts in this context-justifying the present research.
A prospective, randomized split-mouth clinical trial with three arms will be conducted at the Complutense University of Madrid. Each patient will undergo bilateral lower third molar extractions under three conditions:
Group A (Test 1): socket filled with autologous tooth graft,
Group B (Test 2): socket filled with bovine xenograft,
Group C (Control): socket left to heal naturally with a blood clot.
The main objective is to evaluate the reduction in probing depth on the distal surface of the second molar six months post-extraction.
Secondary outcomes include postoperative pain, inflammation, trismus, complications, wound healing, and patient-reported outcomes (PoSSe questionnaire).
Approximately 30 patients will be included, with triple randomization (side of first extraction, use of graft, and graft type). Clinical and radiographic evaluations will be performed preoperatively, and follow-ups will occur at 48 hours, one week, three months, and six months.
The null hypothesis (H₀) states that there will be no periodontal differences between the two graft materials, while the alternative hypothesis (H₁) proposes superior periodontal outcomes with the autologous tooth graft compared to the bovine xenograft.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Miguel Ruiz Rincón, DDS
- Número de telefone: +34 680276072
- E-mail: migrui02@ucm.es
Locais de estudo
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Madrid
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Madrid, Madrid, Espanha, 28040
- Recrutamento
- Postgrado de especialización en cirugía bucal e implantología, Facultad de Odontología, Universidad Complutense de Madrid
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Contato:
- Miguel Ruiz Rincón, DDS
- Número de telefone: +34 680 27 60 72
- E-mail: migrui02@ucm.es
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Adults (≥18 years old) of any sex, able to understand and follow study instructions.
- Patients requiring bilateral surgical extraction of impacted lower third molars in horizontal or mesioangular position.
- Presence of both lower second molars.
- Classified as ASA I or ASA II (according to the American Society of Anesthesiologists).
- Willingness to participate voluntarily and sign informed consent.
Exclusion Criteria:
- Age under 18 years.
- ASA physical status III, IV, V, or VI.
- Pregnant or breastfeeding women.
- Immunosuppressed patients.
- Current treatment with NSAIDs, anticoagulants, or acetylsalicylic acid.
- Previous or current treatment with bisphosphonates.
- Presence of oral dysplasia or precancerous lesions.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Autologous Tooth Graft (Test 1)
After surgical extraction of the impacted lower third molar, the socket will be filled with autologous tooth graft particles obtained from the extracted tooth using the Smart Dentin Grinder®.
The graft particles (300-1200 µm) will be decontaminated, rinsed, and placed on the distal surface of the second molar.
The graft will be covered with a resorbable hemostatic sponge (Roeko Gelatamp®) before suturing.
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Autologous tooth graft particles are prepared from the extracted third molar using the Smart Dentin Grinder®.
The tooth is cleaned, dried, and ground to particles of 300-1200 µm, decontaminated with 0.5 M sodium hydroxide and 20% ethanol, rinsed with sterile saline, and placed on the distal surface of the second molar.
The graft is covered with a resorbable hemostatic sponge (Roeko Gelatamp®) prior to wound closure.
Outros nomes:
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Comparador Ativo: Bovine Xenograft (Test 2)
After extraction of the impacted lower third molar, the socket will be filled with particulate bovine xenograft (InterOss®) hydrated in sterile saline.
The material will be placed on the distal surface of the second molar and covered with a resorbable hemostatic sponge before suturing.
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Autologous tooth graft particles are prepared from the extracted third molar using the Smart Dentin Grinder®.
The tooth is cleaned, dried, and ground to particles of 300-1200 µm, decontaminated with 0.5 M sodium hydroxide and 20% ethanol, rinsed with sterile saline, and placed on the distal surface of the second molar.
The graft is covered with a resorbable hemostatic sponge (Roeko Gelatamp®) prior to wound closure.
Outros nomes:
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Sem intervenção: Blood Clot (Control)
Following extraction of the impacted lower third molar, the socket will be left to heal naturally through blood clot formation, without placement of any graft material or hemostatic sponge.
Standard wound closure and postoperative care will be provided.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Reduction in probing depth on the distal surface of the mandibular second molar
Prazo: Baseline (preoperative), 3 months, and 6 months post-extraction
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Periodontal probing depth (in millimeters) measured on the distal surface of the lower second molar using a calibrated periodontal probe (CP12).
The reduction in probing depth will be compared among the three groups (autologous tooth graft, bovine xenograft, and blood clot control) to evaluate periodontal healing following extraction of the lower third molars.
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Baseline (preoperative), 3 months, and 6 months post-extraction
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Postoperative swelling
Prazo: Preoperative, 48 hours, and 7 days post-extraction
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Facial swelling measured as the linear distance between anatomical landmarks (tragus-commissure, tragus-gonion, and gonion-commissure) using a suture thread and caliper.
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Preoperative, 48 hours, and 7 days post-extraction
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Postoperative trismus
Prazo: Preoperative, 48 hours, and 7 days post-extraction
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Maximum interincisal mouth opening measured in millimeters using a caliper.
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Preoperative, 48 hours, and 7 days post-extraction
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Wound healing quality
Prazo: 48 hours, and 7 days post-extraction
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linical evaluation of the surgical site according to Blum's criteria (good, acceptable, poor), based on mucosal color, bleeding, wound margins, and closure.
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48 hours, and 7 days post-extraction
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Patient-reported quality of life
Prazo: 7 days post-extraction
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Assessed using the Postoperative Symptom Severity (PoSSe) scale, covering pain, function, daily activities, and social interaction after surgery.
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7 days post-extraction
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Surgical time
Prazo: Intraoperatively
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Minutes and seconds recorded intraoperatively
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Intraoperatively
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Surgical difficulty
Prazo: Intraoperatively
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Classified according to the modified Parant scale: Types I-IV
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Intraoperatively
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: José María Martínez-González, MD,DMD,PhD,MDV, Department of Dental Clinical Specialties, Faculty of Dentistry, Complutense University of Madrid
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Outros números de identificação do estudo
- 25/636-EC_X
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