Tooth LossNCT03580798
Ridge Preservation Comparing Simultaneous vs. Delayed Grafting
A study testing Delayed graft and Simultaneous graft in people with Tooth Loss, run by University of Louisville at 1 site in United States.
Trial summary
Comparison of the clinical healing of simultaneous vs. delayed grafting for dental implant placement. 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?
- Delayed graft and Simultaneous graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2018to 26 Apr 2019
- 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
- Have one non-molar maxillary tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by 2 teeth.
- Healthy persons at least 18 years old.
- Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.
Who cannot join
- Patients with debilitating systemic disease, or diseases that have a clinically significant effect on the periodontium.
- Exclude any molar tooth.
- Presence of or history of osteonecrosis of jaws.
- Patients with current or previous history of IV bisphosphonates, irrespective of duration.
- Patients taking oral bisphosphonates for ≥ 3 years.
- Pregnant women.
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- Allergy to any material or medication used in the study.
- Patients who need prophylactic antibiotics prior to dental procedures.
- Previous head and neck radiation therapy.
- Chemotherapy in the previous 12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Graduate Periodontics, UofL School of Dentistry
Louisville, Kentucky, 40202
About this study
Official title: Ridge Preservation Comparing the Traditional Approach vs. Early Implant Placement With Simultaneous Contour Augmentation
Comparison of the clinical healing of simultaneous vs. delayed grafting for dental implant placement.
Read the detailed description
The primary aims of this study are to compare the clinical and histologic results of a traditional ridge preservation with implant placement at 16 weeks (control group) with early implant placement (8 weeks) with simultaneous contour augmentation as described by Buser (test group).
- Conditions
- Tooth Loss
- Being tested
- Delayed graft, Simultaneous graft
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed graftProcedure or surgery
8 weeks post-extraction 15 test patients will receive implant placement plus osseous grafting.
Simultaneous graftProcedure or surgery
At the time of extraction osseous graft will be placed in the socket and implant placed 4 months later.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Grafting | Experimental | 8 weeks after extraction implant placement and simultaneous osseous grafting. Receives: Procedure: Delayed graft |
| Simultaneous Grafting | Active comparator | At the time of extraction the socket will be grafted and implant placed 4 months later. Receives: Procedure: Simultaneous graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final ridge width for simultaneous and delayed grafting treatment.
Measure final ridge width to determine if adequate bone is available.
Measured: 16 to 20 weeks
Secondary outcomes (3)
Soft tissue thickness
Facial and occlusal
Measured: 16 to 20 weeks
Histology
Histologic composition for control group only
Measured: 16 weeks
Implant dehiscence
Implant dehiscence
Measured: 20 weeks
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 start8 Nov 2018
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Why it stopped: Not enough patients available
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.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 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, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580798
- Sponsor's protocol ID
- 18.0348
- Status last verified
- Sep 2020
- First submitted
- 13 Jun 2018
- Last updated
- 10 Sep 2020
- 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 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Preservation Comparing the Traditional Approach vs. Early Implant Placement With Simultaneous Contour Augmentation
- ClinicalTrials.gov ID
- NCT03580798
- Acronym / sponsor ID
- 18.0348
- Conditions
- Tooth Loss
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patients available
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (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.
Comparison of the clinical healing of simultaneous vs. delayed grafting for dental implant placement.
Detailed description
The primary aims of this study are to compare the clinical and histologic results of a traditional ridge preservation with implant placement at 16 weeks (control group) with early implant placement (8 weeks) with simultaneous contour augmentation as described by Buser (test group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Grafting | Experimental | Procedure: Delayed graft8 weeks after extraction implant placement and simultaneous osseous grafting. |
| Simultaneous Grafting | Active comparator | Procedure: Simultaneous graftAt the time of extraction the socket will be grafted and implant placed 4 months later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have one non-molar maxillary tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by 2 teeth.
- Healthy persons at least 18 years old.
- Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.
Key exclusion criteria (10 listed)
- Patients with debilitating systemic disease, or diseases that have a clinically significant effect on the periodontium.
- Exclude any molar tooth.
- Presence of or history of osteonecrosis of jaws.
- Patients with current or previous history of IV bisphosphonates, irrespective of duration.
- Patients taking oral bisphosphonates for ≥ 3 years.
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 |
|---|---|---|
| Delayed graft8 weeks post-extraction 15 test patients will receive implant placement plus osseous grafting. | Procedure or surgery | Delayed Grafting |
| Simultaneous graftAt the time of extraction osseous graft will be placed in the socket and implant placed 4 months later. | Procedure or surgery | Simultaneous Grafting |
Primary outcome
Final ridge width for simultaneous and delayed grafting treatment.
Time frame: 16 to 20 weeks
Measure final ridge width to determine if adequate bone is available.
3 secondary outcomes
Soft tissue thickness
Time frame: 16 to 20 weeks
Histology
Time frame: 16 weeks
Implant dehiscence
Time frame: 20 weeks
Results and safety
The study was stopped early (reason given: Not enough patients available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- 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.
Henry Greenwell, DMD 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 Delayed graft and Simultaneous graft in people with Tooth Loss, 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 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: stopped early, as of the sponsor's last update on 10 Sep 2020. 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 was stopped early (reason given: Not enough patients available). Results are not available in the source record.
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?
Final ridge width for simultaneous and delayed grafting treatment. (time frame: 16 to 20 weeks). 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 Sep 2020.