Periodontal Defects After Third Molar Extraction
Conditions
Brief summary
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.
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.
Interventions
BIOLOGICALAutologous Tooth Graft
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.
Sponsors
Universidad Complutense de Madrid
Bioner
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Each participant will receive two different interventions on opposite sides of the mandible in a randomized split-mouth design, comparing autologous tooth graft, bovine xenograft, and natural healing (blood clot).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in probing depth on the distal surface of the mandibular second molar | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative swelling | 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. |
| Postoperative trismus | Preoperative, 48 hours, and 7 days post-extraction | Maximum interincisal mouth opening measured in millimeters using a caliper. |
| Wound healing quality | 48 hours, and 7 days post-extraction | linical evaluation of the surgical site according to Blum's criteria (good, acceptable, poor), based on mucosal color, bleeding, wound margins, and closure. |
| Patient-reported quality of life | 7 days post-extraction | Assessed using the Postoperative Symptom Severity (PoSSe) scale, covering pain, function, daily activities, and social interaction after surgery. |
Countries
Spain
Contacts
CONTACTMiguel Ruiz Rincón, DDS
STUDY_DIRECTORJosé María Martínez-González, MD,DMD,PhD,MDV
Department of Dental Clinical Specialties, Faculty of Dentistry, Complutense University of Madrid
Outcome results
None listed