Periodontal Defects After Third Molar ExtractionNCT07824518
Comparison of Autologous Tooth and Bovine Xenograft in Periodontal Healing After Mandibular Third Molar Extraction
A study testing Autologous Tooth Graft in people with Periodontal Defects After Third Molar Extraction and Periodontal Disease, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Defects After Third Molar Extraction, Periodontal Disease
- What is being tested?
- Autologous Tooth Graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 30 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Postgrado de especialización en cirugía bucal e implantología, Facultad de Odontología, Universidad Complutense de Madrid
Madrid, Madrid, 28040
Miguel Ruiz Rincón, DDS, 680 27 60 72 ext. +34, migrui02@ucm.es
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Autologous Tooth Graft
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Tooth GraftBiological
Also called Smart Dentin Grinder®
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.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Tooth Graft (Test 1) | Experimental | 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. Receives: Biological: Autologous Tooth Graft |
| Bovine Xenograft (Test 2) | Active comparator | 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. Receives: Biological: Autologous Tooth Graft |
| Blood Clot (Control) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (preoperative), 3 months, and 6 months post-extraction
Secondary outcomes (4)
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.
Measured: Preoperative, 48 hours, and 7 days post-extraction
Postoperative trismus
Maximum interincisal mouth opening measured in millimeters using a caliper.
Measured: Preoperative, 48 hours, and 7 days post-extraction
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.
Measured: 48 hours, and 7 days post-extraction
Patient-reported quality of life
Assessed using the Postoperative Symptom Severity (PoSSe) scale, covering pain, function, daily activities, and social interaction after surgery.
Measured: 7 days post-extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Sep 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Defects After Third Molar ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Bioner
- Responsible party
- Principal investigator, Miguel Ruiz Rincón, Universidad Complutense de Madrid
- Investigators
- José María Martínez-González, MD,DMD,PhD,MDV, Study director, Department of Dental Clinical Specialties, Faculty of Dentistry, Complutense University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824518
- Sponsor's protocol ID
- 25/636-EC_X
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) from this study will be shared with qualified researchers after the publication of primary results. Shared data will include anonymized measurements of periodontal probing depth, postoperative outcomes (pain, swelling, trismus), PoSSe questionnaire responses, and relevant demographic and clinical variables. Data will be de-identified to protect participant confidentiality.