Dental ImplantsNCT03580811
Clinical Effects of Hard and Soft Tissue Grafting With Dental Implants
A study testing Dental Implant &ADMG and Dental implant & ADMG & BDX in people with Dental Implants, run by University of Louisville at 1 site in United States.
Trial summary
The study will be done to see if Implant placement and simultaneous grafting using alloderm alone will result in the same facial ridge contour and soft tissue thickness as alloderm plus bovine derived xenograft. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- Dental Implant &ADMG and Dental implant & ADMG & BDX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2018to 30 Apr 2021
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have one edentulous site bordered by 2 teeth in maxillary sites from second premolar to second premolar (maxillary 4 to 13) to receive an implant with simultaneous grafting with an ADMG with or without BDX.
- Healthy persons at least 18 years old.
- Understands and has signed the informed consent.
Who cannot join
- Patients with uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium.
- Previous head and neck radiation.
- Patients who have taken oral bisphosphonates for > 3 years or any IV bisphosphonates.
- Smokers (or other tobacco habits that might interfere with soft tissue healing).
- Patients who need prophylactic antibiotics prior to dental procedures.
- Patients with allergies to any medication or material used in the study, or that would adversely affect study procedures.
Show all 11Show fewer
- Chemotherapy in the previous 12 months.
- Psychological problems that would interfere with treatment.
- Pregnant subjects will be excluded due to risk of miscarriage
- Patients unable or unwilling to sign the informed consent.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Graduate Periodontics University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: The Clinical Effect of Simultaneous Grafting With Implant Placement Comparing Soft Tissue Grafting Alone to Combined Hard and Soft Tissue Grafting
The study will be done to see if Implant placement and simultaneous grafting using alloderm alone will result in the same facial ridge contour and soft tissue thickness as alloderm plus bovine derived xenograft. Is the facial soft tissue contour and thickness for alloderm plus bovine derived xenograft is significantly increased compared to alloderm alone.
Read the detailed description
Thirty sequentially entered patients will have a dental implant placed in maxillary sites from 4 to 13. Any implant system is acceptable since the objective of the study is to evaluate soft tissue contour due to graft placement, not to evaluate the implant. Once selected for participation immediately prior to treatment, they are randomized for a treatment group by a coin toss. Fifteen patients will receive Alloderm alone (Positive Control Group) while another fifteen will receive Alloderm plus Bovine derived Xenograft (Test Group). The graft will be placed simultaneously with the dental implant. A blinded examiner Dr.Jodie Lusby will be used. Should the examiner become unblinded the subject will be excluded from the study. Means and standard deviations will be calculated for all parameters. A paired test will be used to evaluate the statistical significance of the differences between initial and final data. An unpaired t-test will be used to evaluate statistical differences between the test and control groups. A sample size of 12 will afford ≥ 80% statistical power to detect a difference of 0.4 mm soft tissue thickness between groups. P value will be set at p≤0.05.
- Conditions
- Dental Implants
- Being tested
- Dental Implant &ADMG, Dental implant & ADMG & BDX
- Keywords
- Alloderm, Dental Implants, Alveolar bone grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Implant &ADMGDevice
A dental implant will be placed and the buccal soft tissue will be grafted using ADMG .
Dental implant & ADMG & BDXDevice
Dental Implant will be placed with ADMG that covers the BDX
| Study group | Role | What they receive |
|---|---|---|
| Dental Implant & ADMG | Active comparator | Dental implant placed with simultaneous grafting using one layer of ADMG Receives: Device: Dental Implant &ADMG |
| Dental implant & ADMG & BDX | Experimental | Dental implant placed plus simultaneous grafting using ADMG with BDX Receives: Device: Dental Implant &ADMG; Device: Dental implant & ADMG & BDX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccal soft tissue contour around dental implant
Contour will be categorized as concave,flat or convex(subjective categories).
Measured: 3 months
Secondary outcomes (1)
Buccal soft tissue thickness around dental implants
The thickness will be measured with an endodontic file using a rubber stopper(objective measure of tissue thickness by penetrating tissue and measuring thickness in millimeters (mm).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start4 Dec 2018
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups of 15 patients . One with soft tissue grafting and implant placement and other with soft and hard tissue grafting with implant placement.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry Greenwell, University of Louisville
- Investigators
- Henry Greenwell, DMD, MSD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580811
- Sponsor's protocol ID
- 18.0470
- Status last verified
- Jun 2021
- First submitted
- 13 Jun 2018
- Last updated
- 3 Jun 2021
- 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 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect of Simultaneous Grafting With Implant Placement Comparing Soft Tissue Grafting Alone to Combined Hard and Soft Tissue Grafting
- ClinicalTrials.gov ID
- NCT03580811
- Acronym / sponsor ID
- 18.0470
- Conditions
- Dental Implants
- Keywords
- Alloderm, Dental Implants, Alveolar bone grafting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 9 Jul 2018 (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 study will be done to see if Implant placement and simultaneous grafting using alloderm alone will result in the same facial ridge contour and soft tissue thickness as alloderm plus bovine derived xenograft. Is the facial soft tissue contour and thickness for alloderm plus bovine derived xenograft is significantly increased compared to alloderm alone.
Detailed description
Thirty sequentially entered patients will have a dental implant placed in maxillary sites from 4 to 13. Any implant system is acceptable since the objective of the study is to evaluate soft tissue contour due to graft placement, not to evaluate the implant. Once selected for participation immediately prior to treatment, they are randomized for a treatment group by a coin toss. Fifteen patients will receive Alloderm alone (Positive Control Group) while another fifteen will receive Alloderm plus Bovine derived Xenograft (Test Group). The graft will be placed simultaneously with the dental implant. A blinded examiner Dr.Jodie Lusby will be used. Should the examiner become unblinded the subject will be excluded from the study. Means and standard deviations will be calculated for all parameters. A paired test will be used to evaluate the statistical significance of the differences between initial and final data. An unpaired t-test will be used to evaluate statistical differences between the test and control groups. A sample size of 12 will afford ≥ 80% statistical power to detect a difference of 0.4 mm soft tissue thickness between groups. P value will be set at p≤0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two groups of 15 patients . One with soft tissue grafting and implant placement and other with soft and hard tissue grafting with implant placement.
| Arm | Type | Receives |
|---|---|---|
| Dental Implant & ADMG | Active comparator | Device: Dental Implant &ADMGDental implant placed with simultaneous grafting using one layer of ADMG |
| Dental implant & ADMG & BDX | Experimental | Device: Dental Implant &ADMG, Device: Dental implant & ADMG & BDXDental implant placed plus simultaneous grafting using ADMG with BDX |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have one edentulous site bordered by 2 teeth in maxillary sites from second premolar to second premolar (maxillary 4 to 13) to receive an implant with simultaneous grafting with an ADMG with or without BDX.
- Healthy persons at least 18 years old.
- Understands and has signed the informed consent.
Key exclusion criteria (11 listed)
- Patients with uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium.
- Previous head and neck radiation.
- Patients who have taken oral bisphosphonates for > 3 years or any IV bisphosphonates.
- Smokers (or other tobacco habits that might interfere with soft tissue healing).
- Patients who need prophylactic antibiotics prior to dental procedures.
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 |
|---|---|---|
| Dental Implant &ADMGA dental implant will be placed and the buccal soft tissue will be grafted using ADMG . | Device | Dental Implant & ADMG, Dental implant & ADMG & BDX |
| Dental implant & ADMG & BDXDental Implant will be placed with ADMG that covers the BDX | Device | Dental implant & ADMG & BDX |
Primary outcome
Buccal soft tissue contour around dental implant
Time frame: 3 months
Contour will be categorized as concave,flat or convex(subjective categories).
1 secondary outcome
Buccal soft tissue thickness around dental implants
Time frame: 3 months
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 3 Jun 2021.
- Individual participant dataSharing planned: No
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L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
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The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
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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.
Henry Greenwell, DMD, MSD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Implant &ADMG and Dental implant & ADMG & BDX in people with Dental Implants, run by University of Louisville 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 3 inclusion and 11 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 3 Jun 2021. 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?
Buccal soft tissue contour around dental implant (time frame: 3 months). 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 3 Jun 2021.