Comparison of Autologous Tooth and Bovine Xenograft in Periodontal Healing After Mandibular Third Molar Extraction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Complutense de Madrid

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Autologous Tooth Graft

    Biological/Vaccine

    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.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Autologous Tooth Graft (Test 1)Experimental treatment 1 intervention
Group B: Bovine Xenograft (Test 2)Active comparator 1 intervention
Group C: Blood Clot (Control)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (preoperative), 3 months, and 6 months post-extraction

Secondary outcomes

1

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.

Time frame
Preoperative, 48 hours, and 7 days post-extraction
2

Postoperative trismus

Maximum interincisal mouth opening measured in millimeters using a caliper.

Time frame
Preoperative, 48 hours, and 7 days post-extraction
3

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.

Time frame
48 hours, and 7 days post-extraction
4

Patient-reported quality of life

Assessed using the Postoperative Symptom Severity (PoSSe) scale, covering pain, function, daily activities, and social interaction after surgery.

Time frame
7 days post-extraction

Other outcomes

1

Surgical time

Minutes and seconds recorded intraoperatively

Time frame
Intraoperatively
2

Surgical difficulty

Classified according to the modified Parant scale: Types I-IV

Time frame
Intraoperatively

Sponsors and contacts

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