AutotransplantationPhase 4ATTEMDNCT06250088
Emdogain Adjunctive to Autotransplantation
A Phase 4 study testing Emdogain (EMD) - test in people with Autotransplantation and Emdogain, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The goal of this randomized clinical trial is to compare the adjunctive use of enamel matrix derivatives in the treatment of tooth autotransplantation in terms of clinical attachment level. The main question it aims to answer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autotransplantation, Emdogain, Autologous Transplantation
- What is being tested?
- Emdogain (EMD) - test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 12 Mar 2024to 1 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
None listed.
Who cannot join
- clinical attachment loss of the donor teeth (CAL less 6 mm)
- compromised general health or patients with systemic diseases that could influence the therapy outcome (uncontrolled diabetes mellitus, bone disorders, etc.)
- pregnant or nursing women
- chronic use of corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or immune-modulator drugs
- patients requiring medications that affect bone metabolism (bisphosphonates
- chronic oral mucosa diseases
Show all 10Show fewer
- evident signs of severe bruxism or clenching habits
- smokers of more than 10 cigarettes per day
- non-compliant patients with 25% plaque index at the time of re-evaluation after non-surgical periodontal therapy and oral hygiene instructions
- patients unable to attend study-related procedures and follow-up visits
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Complutense de Madrid
Madrid, 28003
Ignacio Pedrinaci, +34 656257658, ipedrinaci@gmail.com
Ignacio Pedrinaci
About this study
Official title: Efficacy of Enamel Matrix Derivatives Adjunctive to Closed-apex Teeth Autotransplantation A Randomized Clinical Trial
The goal of this randomized clinical trial is to compare the adjunctive use of enamel matrix derivatives in the treatment of tooth autotransplantation in terms of clinical attachment level. The main question it aims to answer. What is the benefit, in terms of clinical attachment level and probing depths, of using enamel matrix derivatives adjunctive to tooth autotransplantation? Participants will be subjected to a digitally guided surgery of tooth autotransplantation. The protocol of the test group will be supplemented with the application of enamel matrix derivatives before the placement of the transplanted tooth into the surgically produced alveolus.
- Being tested
- Emdogain (EMD) - test, Sham group
- Keywords
- Emdogain and tooth autotransplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emdogain (EMD) - testBiological
Initially, tooth sectioning of the hopeless tooth (receptor) will be carried out using fissure carbide burs, and the resulting fragments will be extracted with a minimally invasive approach. A multiple drilling axis tooth-supported surgical guide will be used to prepare the recipient site in accordance with the 3D planning. Additional alveoloplasty procedures will be performed with round diamond burs if necessary to adapt the computer assisted rapid prototyping (CARP) model to the virtual planning position. The donor tooth will be extracted as atraumatically as possible, utilizing a piezoelectric if ostectomy is required, and avoiding the use of elevators or forceps over the root surface. Extraorally, (Emdogain) EMD will be applied to the root surface of the donor tooth. Sutures will be applied to closely adapt the soft tissues around the autotransplanted tooth. A semi-rigid orthodontic wire will be used to splint the tooth to the mesial and distal adjacent teeth
Sham groupProcedure or surgery
Initially, tooth sectioning of the hopeless tooth (receptor) will be carried out using fissure carbide burs, and the resulting two fragments will be extracted with a minimally invasive approach. A multiple drilling axis tooth-supported surgical guide will be used to prepare the recipient site in accordance with the 3D planning. Additional alveoloplasty procedures will be performed with round diamond burs if necessary to adapt thecomputer assisted rapid prototyping (CARP) model to the virtual planning position. The donor tooth will be extracted as atraumatically as possible, utilizing a piezoelectric surgical instrument if ostectomy is required, and avoiding the use of elevators or forceps over the root surface. No Emdodain (EMD). Sutures will be applied to closely adapt the soft tissues around the autotransplanted tooth. A semi-rigid orthodontic wire will be used to splint the tooth to the mesial and distal adjacent teeth
| Study group | Role | What they receive |
|---|---|---|
| Emdogain (EMD) | Active comparator | Not described Receives: Biological: Emdogain (EMD) - test; Procedure: Sham group |
| Control | Sham comparator | Not described Receives: Procedure: Sham group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Level
measured as the distance in mm from the CEJ to the bottom of the pocket will be the primary outcome of this study.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Radiographic bone level
Changes in marginal bone levels (MBLs), measured as the change in interproximal bone levels between 4 weeks after autotransplantation, six months and one year postoperatively. MBLs are defined as the distance between the cementoenamel junction (CEJ) and to the crestal bone level at the mesial and distal aspect . These measurements will also be recorded at the adjacent teeth/implants. For standardization of the radiographic technique, a customized bite block will be constructed for each patient using a parallel technique X-ray film holder (i.e.Rinn System, x-ray system or similar) and heavy silicone. The obtained digital radiographs will be evaluated using the image software (OsiriX Imaging Software, Geneva, Switzerland), with previous calibration of the images by inserting a small metal object of known measures in the bite block
Measured: through study completion, an average of 1 year
Digital image assessment. Position of the Alveolar Ridge Measurements
For each patient, the baseline and the last follow-up visit STL files and Digital Imaging and Communications in Medicine (DICOM) files will be superimposed for best-fit alignment. Alveolar ridge width changes will also be evaluated at the buccal and lingual mesial, mid, and distal sites. A sagittal section at each area of interest will be made. Horizontal alveolar ridge width linear changes will be quantified in mm at three predetermined reference points established at 1, 3, and 5mm from the baseline gingival margin.
Measured: at the study completion. an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start12 Mar 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutotransplantationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Pedrinaci Peñalver, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250088
- Sponsor's protocol ID
- ATT_EMD_RCT
- Acronym
- ATTEMD
- Status last verified
- May 2024
- First submitted
- 23 Jan 2024
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Enamel Matrix Derivatives Adjunctive to Closed-apex Teeth Autotransplantation A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06250088
- Acronym / sponsor ID
- ATTEMD / ATT_EMD_RCT
- Keywords
- Emdogain and tooth autotransplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 8 Feb 2024 (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.
The goal of this randomized clinical trial is to compare the adjunctive use of enamel matrix derivatives in the treatment of tooth autotransplantation in terms of clinical attachment level. The main question it aims to answer. What is the benefit, in terms of clinical attachment level and probing depths, of using enamel matrix derivatives adjunctive to tooth autotransplantation? Participants will be subjected to a digitally guided surgery of tooth autotransplantation. The protocol of the test group will be supplemented with the application of enamel matrix derivatives before the placement of the transplanted tooth into the surgically produced alveolus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emdogain (EMD) | Active comparator | Biological: Emdogain (EMD) - test, Procedure: Sham group |
| Control | Sham comparator | Procedure: Sham group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- clinical attachment loss of the donor teeth (CAL less 6 mm)
- compromised general health or patients with systemic diseases that could influence the therapy outcome (uncontrolled diabetes mellitus, bone disorders, etc.)
- pregnant or nursing women
- chronic use of corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or immune-modulator drugs
- patients requiring medications that affect bone metabolism (bisphosphonates
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 |
|---|---|---|
| Emdogain (EMD) - testInitially, tooth sectioning of the hopeless tooth (receptor) will be carried out using fissure carbide burs, and the resulting fragments will be extracted with a minimally invasive approach. A multiple drilling axis tooth-supported surgical guide will be used to prepare the recipient site in accordance with the 3D planning. Additional alveoloplasty procedures will be performed with round diamond burs if necessary to adapt the computer assisted rapid prototyping (CARP) model to the virtual planning position. The donor tooth will be extracted as atraumatically as possible, utilizing a piezoelectric if ostectomy is required, and avoiding the use of elevators or forceps over the root surface. Extraorally, (Emdogain) EMD will be applied to the root surface of the donor tooth. Sutures will be applied to closely adapt the soft tissues around the autotransplanted tooth. A semi-rigid orthodontic wire will be used to splint the tooth to the mesial and distal adjacent teeth | Biological | Emdogain (EMD) |
| Sham groupInitially, tooth sectioning of the hopeless tooth (receptor) will be carried out using fissure carbide burs, and the resulting two fragments will be extracted with a minimally invasive approach. A multiple drilling axis tooth-supported surgical guide will be used to prepare the recipient site in accordance with the 3D planning. Additional alveoloplasty procedures will be performed with round diamond burs if necessary to adapt thecomputer assisted rapid prototyping (CARP) model to the virtual planning position. The donor tooth will be extracted as atraumatically as possible, utilizing a piezoelectric surgical instrument if ostectomy is required, and avoiding the use of elevators or forceps over the root surface. No Emdodain (EMD). Sutures will be applied to closely adapt the soft tissues around the autotransplanted tooth. A semi-rigid orthodontic wire will be used to splint the tooth to the mesial and distal adjacent teeth | Procedure or surgery | Control, Emdogain (EMD) |
Primary outcome
Clinical Attachment Level
Time frame: through study completion, an average of 1 year
measured as the distance in mm from the CEJ to the bottom of the pocket will be the primary outcome of this study.
2 secondary outcomes
Radiographic bone level
Time frame: through study completion, an average of 1 year
Digital image assessment. Position of the Alveolar Ridge Measurements
Time frame: at the study completion. an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
Related trials for Autotransplantation
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
Not yet recruiting
Allograft vs. Autograft Nonunion
Nonunion Fracture
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Not yet recruiting
Dry Needling and Quad Strength After Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Reconstruction Rehabilitation, Dry Needling
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Emdogain (EMD) - test in people with Autotransplantation and Emdogain, 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 0 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 9 May 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment Level (time frame: through study completion, an average of 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 9 May 2024.