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
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Miguel Ruiz Rincón, DDS
- Phone Number: +34 680276072
- Email: migrui02@ucm.es
Study Locations
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Madrid
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Madrid, Madrid, Spain, 28040
- Recruiting
- Postgrado de especialización en cirugía bucal e implantología, Facultad de Odontología, Universidad Complutense de Madrid
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Contact:
- Miguel Ruiz Rincón, DDS
- Phone Number: +34 680 27 60 72
- Email: migrui02@ucm.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
Other Names:
|
|
Active Comparator: 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.
Other Names:
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in probing depth on the distal surface of the mandibular second molar
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative swelling
Time Frame: 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.
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Preoperative, 48 hours, and 7 days post-extraction
|
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Postoperative trismus
Time Frame: 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
Time Frame: 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
Time Frame: 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.
|
7 days post-extraction
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Surgical time
Time Frame: Intraoperatively
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Minutes and seconds recorded intraoperatively
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Intraoperatively
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Surgical difficulty
Time Frame: Intraoperatively
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Classified according to the modified Parant scale: Types I-IV
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Intraoperatively
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: José María Martínez-González, MD,DMD,PhD,MDV, Department of Dental Clinical Specialties, Faculty of Dentistry, Complutense University of Madrid
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 25/636-EC_X
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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