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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07824518
- Acronym / sponsor ID
- 25/636-EC_X
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Bioner
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Autologous Tooth Graft (Test 1) | Experimental | Biological: Autologous Tooth GraftAfter 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. |
| Bovine Xenograft (Test 2) | Active comparator | Biological: Autologous Tooth GraftAfter 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Tooth GraftAlso: 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. | Biological | Autologous Tooth Graft (Test 1), Bovine Xenograft (Test 2) |
Primary outcome
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.
4 secondary outcomes
Postoperative swelling
Time frame: Preoperative, 48 hours, and 7 days post-extraction
Postoperative trismus
Time frame: Preoperative, 48 hours, and 7 days post-extraction
Wound healing quality
Time frame: 48 hours, and 7 days post-extraction
Patient-reported quality of life
Time frame: 7 days post-extraction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
José María Martínez-González, MD,DMD,PhD,MDV study director
Department of Dental Clinical Specialties, Faculty of Dentistry, Complutense University of Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miguel Ruiz Rincón, DDS (680276072 ext. +34, migrui02@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in probing depth on the distal surface of the mandibular second molar (time frame: Baseline (preoperative), 3 months, and 6 months post-extraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.