Determination of Beneficial Effect of Using Enamel Matrix Derivative During Implant TreatmentNCT05419102
Retrospective Study of Implants With Peri-implantitis Surgically Treated Using Enamel Matrix Derivative (EMD)
An observational study of Determination of Beneficial Effect of Using Enamel Matrix Derivative During Implant Treatment, run by North Dallas Dental Health at 1 site in United States.
Trial summary
The existing records of a private practice limited to the practice of periodontology were reviewed to locate patients who had been diagnosed with peri-implantitis (failing dental implant) and had been surgically treated utilizing enamel matrix derivative (Commercially available FDA product Emdogain sold by Straumann… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Determination of Beneficial Effect of Using Enamel Matrix Derivative During Implant Treatment
- What is being tested?
- peri-implantitis surgery with enamel matrix derivative
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 6 Jun 2022
- How long will I take part?
- 7 Years
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Routine adult patients in a private periodontal practice.
Who may be able to join
- all adult patients of record who presented with existing peri-implantitis that was clinically deemed treatable (the implant was not considered hopeless.)
Who cannot join
- none except for routine medical contraindications for periodontal surgery
Trial locations and contacts
1 site in 1 country.
About this study
The existing records of a private practice limited to the practice of periodontology were reviewed to locate patients who had been diagnosed with peri-implantitis (failing dental implant) and had been surgically treated utilizing enamel matrix derivative (Commercially available FDA product Emdogain sold by Straumann USA). Various clinical factors were gathered from the existing records. Some of the factors recorded were: retention of the implant, presence of bleeding, presence of further damage, and presence of inflammation. All patients had signed an informed consent for treatment and the anonymous use of their data for research purposes. All HIPA requirements were followed.
Read the detailed description
See brief summary.
- Conditions
- Determination of Beneficial Effect of Using Enamel Matrix Derivative During Implant Treatment
- Being tested
- peri-implantitis surgery with enamel matrix derivative
- Keywords
- dental implant, peri-implantitis, enamel matrix derivative
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peri-implantitis surgery with enamel matrix derivativeProcedure or surgery
surgical procedures around dental implants with peri-implantits to remove infectious material and apply enamel matrix derivative to the implant.
What is being measured
The primary outcome is the main question the study is designed to answer.
retention of the implant
Determine if the implant was still present at the time of reevaluation
Measured: 0.71 to 6.4 years
Secondary outcomes (1)
record the clinical condition of the implant at the time of reevaluation
Multiple standard measurements of the clinical condition of the implant were recorded at the time of reevaluation
Measured: 0.71 to 6.4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Apr 2022
- Primary completion15 May 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Determination of Beneficial Effect of Using Enamel Matrix Derivative During Implant TreatmentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 34 participants (actual)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- North Dallas Dental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas G Wilson, Jr. DDS, North Dallas Dental Health
- Investigators
- Thomas G Wilson, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419102
- Sponsor's protocol ID
- EMD Implant 1
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Implants With Peri-implantitis Surgically Treated Using Enamel Matrix Derivative (EMD)
- ClinicalTrials.gov ID
- NCT05419102
- Acronym / sponsor ID
- EMD Implant 1
- Conditions
- Determination of Beneficial Effect of Using Enamel Matrix Derivative During Implant Treatment
- Keywords
- dental implant, peri-implantitis, enamel matrix derivative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- North Dallas Dental HealthUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 15 Jun 2022 (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 existing records of a private practice limited to the practice of periodontology were reviewed to locate patients who had been diagnosed with peri-implantitis (failing dental implant) and had been surgically treated utilizing enamel matrix derivative (Commercially available FDA product Emdogain sold by Straumann USA). Various clinical factors were gathered from the existing records. Some of the factors recorded were: retention of the implant, presence of bleeding, presence of further damage, and presence of inflammation. All patients had signed an informed consent for treatment and the anonymous use of their data for research purposes. All HIPA requirements were followed.
Detailed description
See brief summary.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 7 Years
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Routine adult patients in a private periodontal practice.
Key inclusion criteria (1 listed)
- all adult patients of record who presented with existing peri-implantitis that was clinically deemed treatable (the implant was not considered hopeless.)
Key exclusion criteria (1 listed)
- none except for routine medical contraindications for periodontal surgery
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 |
|---|---|---|
| peri-implantitis surgery with enamel matrix derivativesurgical procedures around dental implants with peri-implantits to remove infectious material and apply enamel matrix derivative to the implant. | Procedure or surgery | – |
Primary outcome
retention of the implant
Time frame: 0.71 to 6.4 years
Determine if the implant was still present at the time of reevaluation
1 secondary outcome
record the clinical condition of the implant at the time of reevaluation
Time frame: 0.71 to 6.4 years
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 Jun 2022.
- Individual participant dataSharing planned: No
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.
Thomas G Wilson principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Determination of Beneficial Effect of Using Enamel Matrix Derivative During Implant Treatment, run by North Dallas Dental Health at 1 site in United States.
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 1 inclusion and 1 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 Jun 2022. 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 United States. 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?
retention of the implant (time frame: 0.71 to 6.4 years). 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 Jun 2022; AzTrials last refreshed its copy on 1 Nov 2026.