Tooth LossATTCSNCT06261255
Autotransplantation and Enamel Matrix Derivatives Case Series
A study testing ATT + EMD in people with Tooth Loss, run by Universidad Complutense de Madrid at 2 sites in Spain.
Trial summary
The goal of this prospective case series is to compare the adjunctive use of enamel matrix derivatives in the treatment of tooth autotransplantation in terms of clinical attachment level. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- ATT + EMD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jun 2020to 1 Dec 2023
- Phase
- Interventional
- 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
- adults (≥18 years old) capable of providing informed consent, teeth deemed unrestorable and in need of replacement
- presence of a viable, healthy, periodontally stable, and nonfunctional tooth (e.g., third molar) suitable for autotransplantation
- periodontally healthy individuals or those with stable periodontal conditions after periodontal therapy.
Who cannot join
- clinical attachment loss of the donor teeth
- 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
2 sites in 1 country.
Spain2 sites
Universidad Complutense de Madrid
Madrid, 28003
Universidad Complutense Madrid
Madrid
About this study
Official title: Efficacy of Digitally Tooth Autotransplantation With Adjunctive Use of Enamel Matrix Derivatives (EMD): A Prospective Case Series
The goal of this prospective case series 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 is:
- What is the benefit, in terms of clinical attachment level, of using enamel matrix derivatives adjunctive to tooth autotransplantation?
Participants will be subjected to a digitally protocol of tooth autotransplantation.Only one group (test) is assessed. It will be supplemented with the application of enamel matrix derivatives before the placement of the transplanted tooth into the surgically produced alveolus.
Read the detailed description
All surgical treatments will be performed by the same experienced periodontist (IP) after the administration of local anesthesia. Initially, tooth sectioning of the hopeless tooth (receptor) will be carried out using fissure carbide burs, and the remaining fragments will be extracted as minimally invasively as possible. A tooth-supported surgical guide will be used to prepare the recipient site following the 3D planning. Additional alveoloplasty procedures will be performed with round diamond burs if necessary to adapt the computed aid 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 osteotomy is required, and avoiding the use of elevators or forceps over the root surface. Extraorally, EMD will be applied to the root surface of the donor tooth.
After positioning the donor tooth onto the surgically created recipient bed, a semi-rigid orthodontic wire will be used to splint the tooth to the mesial and distal adjacent teeth, and sutures will be applied to closely adapt the soft tissues around the autotransplanted tooth. Occlusal adjustments will be made if necessary. Alternatively, orthodontic composite bite stops will be placed on top of adjacent teeth to obtain temporary dental disocclusion.
- Conditions
- Tooth Loss
- Being tested
- ATT + EMD
- Keywords
- emdogain, enamel matrix derivatives, tooth autotransplantation, tooth autogenous transplantation, digital planning
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATT + EMDProcedure or surgery
All surgical treatments will be performed by the same experienced periodontist (IP) after the administration of local anesthesia. Initially, tooth sectioning of the hopeless tooth (receptor) will be carried out using fissure carbide burs, and the remaining fragments will be extracted as minimally invasively as possible. A tooth-supported surgical guide will be used to prepare the recipient site following the 3D planning. Additional alveoloplasty procedures will be performed with round diamond burs if necessary to adapt the CARP model to the virtual planning position. The donor tooth will be extracted as atraumatically as possible, utilizing a piezoelectric surgical instrument if osteotomy is required, and avoiding the use of elevators or forceps over the root surface. Extraorally, EMD will be applied to the root surface of the donor tooth
| Study group | Role | What they receive |
|---|---|---|
| ATT + EMD | Experimental | There is only 1 arm, autotransplantation (ATT) + adjunctive EMD Receives: Procedure: ATT + EMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level (CAL)
CAL level changes on the donor tooth between the baseline situation and the last follow up visit.
Measured: through 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 posted15 Feb 2024
- Study start1 Jun 2020
- Primary completion1 Sep 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This clinical investigation is a single-center, prospective case series study and is reported in compliance with the Preferred Reporting of Case Series in Surgery (PROCESS) guidelines. The study was conducted at the Department of Periodontology of the University Complutense of Madrid between March 2021 and September 2023.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
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
- Investigators
- Ignacio Pedrinaci, DDS, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261255
- Sponsor's protocol ID
- ATT_CS
- Acronym
- ATTCS
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- 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 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Digitally Tooth Autotransplantation With Adjunctive Use of Enamel Matrix Derivatives (EMD): A Prospective Case Series
- ClinicalTrials.gov ID
- NCT06261255
- Acronym / sponsor ID
- ATTCS / ATT_CS
- Conditions
- Tooth Loss
- Keywords
- emdogain, enamel matrix derivatives, tooth autotransplantation, tooth autogenous transplantation, digital planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 15 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 prospective case series 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 is:
- What is the benefit, in terms of clinical attachment level, of using enamel matrix derivatives adjunctive to tooth autotransplantation?
Participants will be subjected to a digitally protocol of tooth autotransplantation.Only one group (test) is assessed. It will be supplemented with the application of enamel matrix derivatives before the placement of the transplanted tooth into the surgically produced alveolus.
Detailed description
All surgical treatments will be performed by the same experienced periodontist (IP) after the administration of local anesthesia. Initially, tooth sectioning of the hopeless tooth (receptor) will be carried out using fissure carbide burs, and the remaining fragments will be extracted as minimally invasively as possible. A tooth-supported surgical guide will be used to prepare the recipient site following the 3D planning. Additional alveoloplasty procedures will be performed with round diamond burs if necessary to adapt the computed aid 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 osteotomy is required, and avoiding the use of elevators or forceps over the root surface. Extraorally, EMD will be applied to the root surface of the donor tooth.
After positioning the donor tooth onto the surgically created recipient bed, a semi-rigid orthodontic wire will be used to splint the tooth to the mesial and distal adjacent teeth, and sutures will be applied to closely adapt the soft tissues around the autotransplanted tooth. Occlusal adjustments will be made if necessary. Alternatively, orthodontic composite bite stops will be placed on top of adjacent teeth to obtain temporary dental disocclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This clinical investigation is a single-center, prospective case series study and is reported in compliance with the Preferred Reporting of Case Series in Surgery (PROCESS) guidelines. The study was conducted at the Department of Periodontology of the University Complutense of Madrid between March 2021 and September 2023.
| Arm | Type | Receives |
|---|---|---|
| ATT + EMD | Experimental | Procedure: ATT + EMDThere is only 1 arm, autotransplantation (ATT) + adjunctive EMD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults (≥18 years old) capable of providing informed consent, teeth deemed unrestorable and in need of replacement
- presence of a viable, healthy, periodontally stable, and nonfunctional tooth (e.g., third molar) suitable for autotransplantation
- periodontally healthy individuals or those with stable periodontal conditions after periodontal therapy.
Key exclusion criteria (10 listed)
- clinical attachment loss of the donor teeth
- 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 |
|---|---|---|
| ATT + EMDAll surgical treatments will be performed by the same experienced periodontist (IP) after the administration of local anesthesia. Initially, tooth sectioning of the hopeless tooth (receptor) will be carried out using fissure carbide burs, and the remaining fragments will be extracted as minimally invasively as possible. A tooth-supported surgical guide will be used to prepare the recipient site following the 3D planning. Additional alveoloplasty procedures will be performed with round diamond burs if necessary to adapt the CARP model to the virtual planning position. The donor tooth will be extracted as atraumatically as possible, utilizing a piezoelectric surgical instrument if osteotomy is required, and avoiding the use of elevators or forceps over the root surface. Extraorally, EMD will be applied to the root surface of the donor tooth | Procedure or surgery | ATT + EMD |
Primary outcome
Clinical attachment level (CAL)
Time frame: through study completion, an average of 1 year
CAL level changes on the donor tooth between the baseline situation and the last follow up visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ignacio Pedrinaci, DDS principal investigator
Universidad Complutense de Madrid
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATT + EMD in people with Tooth Loss, run by Universidad Complutense de Madrid at 2 sites 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 3 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: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (CAL) (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 15 Feb 2024.