ClinicalTrials.gg
RecruitingNCT07824518Updated Oct 1, 2026

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

An interventional study of Autologous Tooth Graft in Periodontal Defects After Third Molar Extraction and Periodontal Disease, sponsored by Universidad Complutense de Madrid. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Sep 2025, registered Sep 2026).
  • Started Sep 2025; still recruiting 1 year 2 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 26 studies in Periodontal Diseases with a site in Spain — 10 open to participants now, 10 under way, none of them phase 3. Periodontal Diseases · Spain.

Planned enrollment
7th of 18
30 · median 29
Started
2025
with 1 other
No phase
16 of 26
7 open now
Registered
26th of 26
by date
Lead sponsor
4 of 26
Universidad Complutense de Madrid

Among the 26 studies in Periodontal Diseases with a site in Spain, this one is the 7th largest by planned enrollment of the 18 interventional ones that give a count, is one of 2 that started in 2025, is one of 16 with no phase, and was the 26th registered.

Periodontal Diseases

867 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.

Browse Periodontal Diseases studies →

Open to participants now

10 of the 26 studies in Periodontal Diseases with a site in Spain are open now. Recruiting first, the newest first:

4 more — sign in →

All 10 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 101 Periodontal Diseases studies recruiting now, 47 (47%) set no upper age limit and 42 (42%) stop at 75 or younger; 5 take children under 18; 58 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study 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.

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.

03

Conditions studied

  • Periodontal Defects After Third Molar Extraction
  • Periodontal Disease

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 or ASA II (according to the American Society of Anesthesiologists).
  • Willingness to participate voluntarily and sign .

Exclusion criteria

Exclusion Criteria:

  • Age under 18 years.
  • III, IV, V, or VI.
  • Pregnant or breastfeeding women.
  • patients.
  • Current treatment with NSAIDs, anticoagulants, or acetylsalicylic acid.
  • Previous or current treatment with bisphosphonates.
  • Presence of oral dysplasia or precancerous lesions.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Autologous Tooth Graft (Test 1)

    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.

    Biological: Autologous Tooth Graft

  • Active comparator
    Bovine Xenograft (Test 2)

    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.

    Biological: Autologous Tooth Graft

  • No intervention
    Blood Clot (Control)

    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.

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.

    Also known as: Smart Dentin Grinder®

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Postgrado de especialización en cirugía bucal e implantología, Facultad de Odontología, Universidad Complutense de Madrid
    Madrid, Madrid 28040, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: IPD will be available beginning 6 months after publication of the primary study results and will remain accessible for 5 years.

Access criteria: Data will be available to researchers who submit a written request describing the purpose of the analysis and who agree to a data use agreement ensuring confidentiality and appropriate use. Requests will be reviewed by the Principal Investigator or designated study committee.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Sep 2026, 12 months after the start.

Of 312 non-industry interventional studies with no phase under Periodontal Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's planned 12 months is close to that.

Counting every sponsor, half of 331 studies reached it within 13 months; a quarter within 8 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2026
First posted
Sep 17, 2026
StartActual
Sep 1, 2025
Primary completionEst.
Sep 30, 2026
CompletionEst.
Sep 30, 2026
Last update
Oct 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: index terms, verification date and conditions
1 update, last Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Minor edits only
    + 3 other changes: index terms, verification date and conditions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07824518
Collaborators
Bioner
Responsible party
Miguel Ruiz Rincón (Department of Dental Clinical Specialties, Faculty of Dentistry, Complutense University of Madrid, Madrid, Spain., Universidad Complutense de Madrid) — Principal investigator
First posted
Sep 17, 2026
Start date
Sep 1, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Oct 1, 2026

Study contacts

Miguel Ruiz Rincón, DDS
Contact
migrui02@ucm.es
680276072 ext. +34
José María Martínez-González, MD,DMD,PhD,MDV
study director · Department of Dental Clinical Specialties, Faculty of Dentistry, Complutense University of Madrid

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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