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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Miguel Ruiz Rincón, DDS
- Telefonnummer: +34 680276072
- E-post: migrui02@ucm.es
Studieorter
-
-
Madrid
-
Madrid, Madrid, Spanien, 28040
- Rekrytering
- Postgrado de especialización en cirugía bucal e implantología, Facultad de Odontología, Universidad Complutense de Madrid
-
Kontakt:
- Miguel Ruiz Rincón, DDS
- Telefonnummer: +34 680 27 60 72
- E-post: migrui02@ucm.es
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
Andra namn:
|
|
Aktiv komparator: 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.
|
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.
Andra namn:
|
|
Inget ingripande: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Reduction in probing depth on the distal surface of the mandibular second molar
Tidsram: Baseline (preoperative), 3 months, and 6 months post-extraction
|
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.
|
Baseline (preoperative), 3 months, and 6 months post-extraction
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative swelling
Tidsram: Preoperative, 48 hours, and 7 days post-extraction
|
Facial swelling measured as the linear distance between anatomical landmarks (tragus-commissure, tragus-gonion, and gonion-commissure) using a suture thread and caliper.
|
Preoperative, 48 hours, and 7 days post-extraction
|
|
Postoperative trismus
Tidsram: Preoperative, 48 hours, and 7 days post-extraction
|
Maximum interincisal mouth opening measured in millimeters using a caliper.
|
Preoperative, 48 hours, and 7 days post-extraction
|
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Wound healing quality
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Surgical time
Tidsram: Intraoperatively
|
Minutes and seconds recorded intraoperatively
|
Intraoperatively
|
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Surgical difficulty
Tidsram: Intraoperatively
|
Classified according to the modified Parant scale: Types I-IV
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Intraoperatively
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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studierektor: José María Martínez-González, MD,DMD,PhD,MDV, Department of Dental Clinical Specialties, Faculty of Dentistry, Complutense University of Madrid
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 25/636-EC_X
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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- STUDY_PROTOCOL
- SAV
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