Tooth ExtractionPhase 4NCT07059247
Periodontal Regeneration at the Distal Site of Second Molars After the Extraction of Lower Included Third Molars
A Phase 4 study testing Application of Enamel Matrix Derivatives and Extraction of the impacted third molar in people with Tooth Extraction and Wisdom Tooth Removal, run by Universidad Complutense de Madrid.
Trial summary
From an exclusively periodontal point of view, the extraction of third molars (3M) or wisdom teeth is relatively frequently recommended, either because they show reduced bone support or to avoid periodontal damage to the supporting bone of the adjacent second molar (2M). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Extraction, Wisdom Tooth Removal, Periodontal Regeneration
- What is being tested?
- Application of Enamel Matrix Derivatives and Extraction of the impacted third molar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Sep 2026
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (< 18 years old) patients with impacted or semi-impacted lower third molars and with indication of extraction
- Systemically healthy patients
- Non-smokers or less than 10 cigarettes per day
Who cannot join
- Patients with uncontrolled systemic diseases (ASA III-IV)
- Medication that potentially affects bone metabolism
- Absence of adjacent lower second molar
- Presence of crowns, distal caries or distal fillings of the adjacent second molar
About this study
From an exclusively periodontal point of view, the extraction of third molars (3M) or wisdom teeth is relatively frequently recommended, either because they show reduced bone support or to avoid periodontal damage to the supporting bone of the adjacent second molar (2M). There are anatomical conditions that make plaque control difficult for the patient, and it is common to find periodontal pockets with significantly increased depths on the distal side of second molars that are or have been closely associated with an impacted third molar.
Among the periodontal considerations regarding impacted third molars, two aspects have traditionally been included: 1)The periodontal damage that certain impactions can cause to the periodontal health of the second molar, and 2) the periodontal sequelae or complications that the extraction of a wisdom tooth may leave on the distal surface of that second molar.
Read more
Various therapeutic approaches have been described in the literature to prevent periodontal damage following the surgical intervention involved in the extraction of a fully or partially impacted wisdom tooth. These include scaling of the distal surface of the 2M after extraction, modifications in the surgical technique - such as flap design or suturing method - and various regenerative techniques.
Within this context, the clinical research in which we invite the patients to participate will be developed. We will study the changes in bone levels on the posterior part of the second molar that is in contact with or close to the third molar, as well as the health of the soft tissues, after performing a conventional extraction protocol of the impacted lower third molar. This protocol includes the placement of a regenerative material of porcine origin (test procedure; enamel matrix derivatives) and will be compared to extraction without such material - and therefore without any attempt at periodontal regeneration (standard procedure). The patients will be closely followed up to one year after the surgical performance. This follow-up will be performed clinically and radiographically.
- Being tested
- Application of Enamel Matrix Derivatives, Extraction of the impacted third molar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Enamel Matrix DerivativesBiological
After the extraction of the impacted lower third molar, EMD will be applied on the distal site of the second molar
Extraction of the impacted third molarProcedure or surgery
Extraction of the impacted third molar
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Application of EMD after the extraction Receives: Biological: Application of Enamel Matrix Derivatives; Procedure: Extraction of the impacted third molar |
| Control | Sham comparator | No application of EMD after the extraction Receives: Procedure: Extraction of the impacted third molar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Level
Measured: From enrollment to the end of treatment at 1 year
Secondary outcomes (2)
Pocket Probing Depth
Measured: From enrollment to the end of treatment at 1 year
Radiographic Bone Level Changes
Measured: From enrollment to the end of treatment at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059247
- Sponsor's protocol ID
- 23/308-EC_X
- Status last verified
- Mar 2025
- First submitted
- 1 Jul 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Regeneration at the Distal Site of Second Molars After the Extraction of Lower Included Third Molars
- ClinicalTrials.gov ID
- NCT07059247
- Acronym / sponsor ID
- 23/308-EC_X
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 10 Jul 2025 (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.
From an exclusively periodontal point of view, the extraction of third molars (3M) or wisdom teeth is relatively frequently recommended, either because they show reduced bone support or to avoid periodontal damage to the supporting bone of the adjacent second molar (2M). There are anatomical conditions that make plaque control difficult for the patient, and it is common to find periodontal pockets with significantly increased depths on the distal side of second molars that are or have been closely associated with an impacted third molar.
Among the periodontal considerations regarding impacted third molars, two aspects have traditionally been included: 1)The periodontal damage that certain impactions can cause to the periodontal health of the second molar, and 2) the periodontal sequelae or complications that the extraction of a wisdom tooth may leave on the distal surface of that second molar.
Various therapeutic approaches have been described in the literature to prevent periodontal damage following the surgical intervention involved in the extraction of a fully or partially impacted wisdom tooth. These include scaling of the distal surface of the 2M after extraction, modifications in the surgical technique - such as flap design or suturing method - and various regenerative techniques.
Within this context, the clinical research in which we invite the patients to participate will be developed. We will study the changes in bone levels on the posterior part of the second molar that is in contact with or close to the third molar, as well as the health of the soft tissues, after performing a conventional extraction protocol of the impacted lower third molar. This protocol includes the placement of a regenerative material of porcine origin (test procedure; enamel matrix derivatives) and will be compared to extraction without such material - and therefore without any attempt at periodontal regeneration (standard procedure). The patients will be closely followed up to one year after the surgical performance. This follow-up will be performed clinically and radiographically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Biological: Application of Enamel Matrix Derivatives, Procedure: Extraction of the impacted third molarApplication of EMD after the extraction |
| Control | Sham comparator | Procedure: Extraction of the impacted third molarNo application of EMD after the extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (< 18 years old) patients with impacted or semi-impacted lower third molars and with indication of extraction
- Systemically healthy patients
- Non-smokers or less than 10 cigarettes per day
Key exclusion criteria (4 listed)
- Patients with uncontrolled systemic diseases (ASA III-IV)
- Medication that potentially affects bone metabolism
- Absence of adjacent lower second molar
- Presence of crowns, distal caries or distal fillings of the adjacent second molar
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 |
|---|---|---|
| Application of Enamel Matrix DerivativesAfter the extraction of the impacted lower third molar, EMD will be applied on the distal site of the second molar | Biological | Test group |
| Extraction of the impacted third molarExtraction of the impacted third molar | Procedure or surgery | Control, Test group |
Primary outcome
Clinical Attachment Level
Time frame: From enrollment to the end of treatment at 1 year
2 secondary outcomes
Pocket Probing Depth
Time frame: From enrollment to the end of treatment at 1 year
Radiographic Bone Level Changes
Time frame: From enrollment to the end of treatment at 1 year
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 10 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Application of Enamel Matrix Derivatives and Extraction of the impacted third molar in people with Tooth Extraction and Wisdom Tooth Removal, run by Universidad Complutense de Madrid.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment Level (time frame: From enrollment to the end of treatment at 1 year). 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 10 Jul 2025.