About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
Age under 18 years.
ASA physical status III, IV, V, or VI.
Pregnant or breastfeeding women.
Immunosuppressed patients.
Trial design
Crossover
Treatments tested in this trial
Autologous Tooth Graft
Biological/VaccineAutologous 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.
Treatment groups
Trial outcomes
Primary outcomes
Reduction in probing depth on the distal surface of the mandibular second molar
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 outcomes
Postoperative swelling
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
Maximum interincisal mouth opening measured in millimeters using a caliper.
Wound healing quality
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
Assessed using the Postoperative Symptom Severity (PoSSe) scale, covering pain, function, daily activities, and social interaction after surgery.
Other outcomes
Surgical time
Minutes and seconds recorded intraoperatively
Surgical difficulty
Classified according to the modified Parant scale: Types I-IV
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad Complutense de Madrid
Lead sponsor
Bioner
Collaborator