Tooth LossNCT03956251
Ridge Preservation With Putty Allografts
A study testing Combined Mineralized/Demineralized Putty Allograft and Demineralized Putty Allograft in people with Tooth Loss, run by University of Louisville at 1 site in United States.
Trial summary
The study will consist of randomized controlled clinical study trial comparing the results of a demineralized putty allorgraft versus a combined mineralized/demineralized putty allograft in approximately 30 patients, 15 per group. All materials used in the study are FDA approved. 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?
- Combined Mineralized/Demineralized Putty Allograft and Demineralized Putty Allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2019to 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
- Healthy male or female who is 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 diseases, or diseases that have a clinically significant effect on the periodontium.
- Presence or history of osteonecrosis of jaws.
- Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
- Patients who have been treated with oral bisphosphonates for more than three years.
- Patients with an allergy to any material or medication used in the study.
- Patients who need prophylactic antibiotics
Show all 10Show fewer
- Previous head and neck radiation therapy.
- Chemotherapy in the previous 12 months.
- Patients on long term NSAID or steroid therapy.
- Pregnant or lactating patients.
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 Clinical and Histologic Healing of Two Different Putty Allografts
The study will consist of randomized controlled clinical study trial comparing the results of a demineralized putty allorgraft versus a combined mineralized/demineralized putty allograft in approximately 30 patients, 15 per group. All materials used in the study are FDA approved.
Read the detailed description
Thirty patients will be treated using the principles of guided bone regeneration utilizing a full thickness flap for ridge preservation. Fifteen test patients will receive an intrasocket demineralized and mineralized combination putty allograft (MinerOss Putty, BioHorizons) covered with a regenerative tissue matrix membrane (AlloDerm GBR, BioHorizons). The positive control group of fifteen patients will receive an intrasocket demineralized putty allograft (Puros, Zimmer) covered with a regenerative tissue matrix membrane (AlloDerm GBR, BioHorizons). Approximately, four months post-surgery, a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.
Prior to surgery, each patient will receive a diagnostic work-up including standardized radiographs (periapicals), study casts, clinical photographs, and a clinical examination to record attachment level, probing depth, recession, and mobility of teeth adjacent to the extracted sites. Customized acrylic occlusal stents will be fabricated on the study casts to serve as fixed reference guides for the measurements. Detailed oral hygiene instructions will be provided.
For histology, trephine core specimens will be evaluated to determine percent vital bone, non-vital bone, and trabecular space. Step serial sections will be taken from each longitudinally sectioned core. The sections will be stained with hematoxylin and eosin. Ten slides per patients will be prepared with at least 4 sections per slide. For each patient, 6 of 10 slides will be assessed. The mean percentage of vital and nonvital bone, and trabecular space will be determined for each patient.
Soft tissue thickness will be measured prior to the procedure. The surgical procedure will consist of a full-thickness papilla preservation flaps performed on the buccal and palatal/lingual to expose the alveolar ridge and the tooth to be extracted. Following the extraction, vertical measurements will be taken with the acrylic occlusal stent in place, and horizontal measurements with a specially designed digital caliper. Both groups will receive an intrasocket graft covered by a regenerative tissue matrix membrane. The control group will receive a demineralized putty allograft. The test group will receive a combination mineralized and demineralized putty allograft. The surgical procedures will be documented with clinical photographs of teeth and/or intraoral structures.
Post surgical management includes all patients will be seen every 2 weeks until 8 weeks post-surgery. Patients will then be seen monthly until month 4 for the final examination and trephine core collection for histological analysis and implant placement. Patients will take doxycycline 100 mg qd for two weeks, Hydrocodone/Acetaminophen 5/325mg q4-6h as needed for pain, and naproxen 375mg q12h for one week for inflammation reduction. Postoperative visits will consist of supragingival plaque removal, and oral hygiene reinforcement Any patient who develops any significant post-operative complications or adverse reaction to the materials used or shows attachment loss greater or equal to 2 mm on teeth adjacent to the experimental site will be exited from the study and will receive appropriate treatment.
- Conditions
- Tooth Loss
- Being tested
- Combined Mineralized/Demineralized Putty Allograft, Demineralized Putty Allograft
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Mineralized/Demineralized Putty AllograftProcedure or surgery
At time of extraction, 15 test patients will receive ridge preservation using Combined Mineralized/Demineralized Putty Allograft
Demineralized Putty AllograftProcedure or surgery
At time of extraction, 15 control patients will receive ridge preservation using Demineralized Putty Allograft
| Study group | Role | What they receive |
|---|---|---|
| Combined Mineralized/Demineralized Putty Allograft | Experimental | Ridge preservation with a Mineralized/Demineralized Putty allograft Receives: Procedure: Combined Mineralized/Demineralized Putty Allograft |
| Demineralized Putty Allograft | Active comparator | Ridge preservation with Demineralized Putty allograft Receives: Procedure: Demineralized Putty Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in horizontal width from post-extraction site to 4-month.
Horizontal post-extraction ridge measurements at the mid-defect alveolar crest and 5 mm apical taken with a caliper.
Measured: 0 and 16 weeks
Secondary outcomes (3)
Change in post extraction ridge height.
Vertical post-extraction ridge measurements from a stent.
- Mid socket osseous crest on facial and lingual
- Mesial and distal socket border - facial and lingual osseous crest.
Measured: 0 and 16 weeks
Change in facial soft tissue thickness and final occlusal soft tissue thickness.
Soft tissue thickness measurements at the crest, 5mm apical, and mid-occlusal post treatment only taken with a #40 endodontic reamer.
Measured: 0 and 16 weeks
Histologic composition. (Histologic percent vital bone, nonvital bone and trabecular space.
Obtain via trephine core
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start29 Aug 2019
- 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 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
- 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 MSc, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956251
- Sponsor's protocol ID
- 19.0516
- Status last verified
- Jun 2021
- First submitted
- 16 May 2019
- 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
- Ridge Preservation Comparing the Clinical and Histologic Healing of Two Different Putty Allografts
- ClinicalTrials.gov ID
- NCT03956251
- Acronym / sponsor ID
- 19.0516
- Conditions
- Tooth Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 20 May 2019 (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 consist of randomized controlled clinical study trial comparing the results of a demineralized putty allorgraft versus a combined mineralized/demineralized putty allograft in approximately 30 patients, 15 per group. All materials used in the study are FDA approved.
Detailed description
Thirty patients will be treated using the principles of guided bone regeneration utilizing a full thickness flap for ridge preservation. Fifteen test patients will receive an intrasocket demineralized and mineralized combination putty allograft (MinerOss Putty, BioHorizons) covered with a regenerative tissue matrix membrane (AlloDerm GBR, BioHorizons). The positive control group of fifteen patients will receive an intrasocket demineralized putty allograft (Puros, Zimmer) covered with a regenerative tissue matrix membrane (AlloDerm GBR, BioHorizons). Approximately, four months post-surgery, a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.
Prior to surgery, each patient will receive a diagnostic work-up including standardized radiographs (periapicals), study casts, clinical photographs, and a clinical examination to record attachment level, probing depth, recession, and mobility of teeth adjacent to the extracted sites. Customized acrylic occlusal stents will be fabricated on the study casts to serve as fixed reference guides for the measurements. Detailed oral hygiene instructions will be provided.
For histology, trephine core specimens will be evaluated to determine percent vital bone, non-vital bone, and trabecular space. Step serial sections will be taken from each longitudinally sectioned core. The sections will be stained with hematoxylin and eosin. Ten slides per patients will be prepared with at least 4 sections per slide. For each patient, 6 of 10 slides will be assessed. The mean percentage of vital and nonvital bone, and trabecular space will be determined for each patient.
Soft tissue thickness will be measured prior to the procedure. The surgical procedure will consist of a full-thickness papilla preservation flaps performed on the buccal and palatal/lingual to expose the alveolar ridge and the tooth to be extracted. Following the extraction, vertical measurements will be taken with the acrylic occlusal stent in place, and horizontal measurements with a specially designed digital caliper. Both groups will receive an intrasocket graft covered by a regenerative tissue matrix membrane. The control group will receive a demineralized putty allograft. The test group will receive a combination mineralized and demineralized putty allograft. The surgical procedures will be documented with clinical photographs of teeth and/or intraoral structures.
Post surgical management includes all patients will be seen every 2 weeks until 8 weeks post-surgery. Patients will then be seen monthly until month 4 for the final examination and trephine core collection for histological analysis and implant placement. Patients will take doxycycline 100 mg qd for two weeks, Hydrocodone/Acetaminophen 5/325mg q4-6h as needed for pain, and naproxen 375mg q12h for one week for inflammation reduction. Postoperative visits will consist of supragingival plaque removal, and oral hygiene reinforcement Any patient who develops any significant post-operative complications or adverse reaction to the materials used or shows attachment loss greater or equal to 2 mm on teeth adjacent to the experimental site will be exited from the study and will receive appropriate treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Mineralized/Demineralized Putty Allograft | Experimental | Procedure: Combined Mineralized/Demineralized Putty AllograftRidge preservation with a Mineralized/Demineralized Putty allograft |
| Demineralized Putty Allograft | Active comparator | Procedure: Demineralized Putty AllograftRidge preservation with Demineralized Putty allograft |
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 tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
- Healthy male or female who is 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 diseases, or diseases that have a clinically significant effect on the periodontium.
- Presence or history of osteonecrosis of jaws.
- Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
- Patients who have been treated with oral bisphosphonates for more than three years.
- Patients with an allergy to any material or medication used in the study.
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 |
|---|---|---|
| Combined Mineralized/Demineralized Putty AllograftAt time of extraction, 15 test patients will receive ridge preservation using Combined Mineralized/Demineralized Putty Allograft | Procedure or surgery | Combined Mineralized/Demineralized Putty Allograft |
| Demineralized Putty AllograftAt time of extraction, 15 control patients will receive ridge preservation using Demineralized Putty Allograft | Procedure or surgery | Demineralized Putty Allograft |
Primary outcome
Change in horizontal width from post-extraction site to 4-month.
Time frame: 0 and 16 weeks
Horizontal post-extraction ridge measurements at the mid-defect alveolar crest and 5 mm apical taken with a caliper.
3 secondary outcomes
Change in post extraction ridge height.
Time frame: 0 and 16 weeks
Change in facial soft tissue thickness and final occlusal soft tissue thickness.
Time frame: 0 and 16 weeks
Histologic composition. (Histologic percent vital bone, nonvital bone and trabecular space.
Time frame: 16 weeks
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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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 MSc 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 Combined Mineralized/Demineralized Putty Allograft and Demineralized Putty Allograft 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: 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?
Change in horizontal width from post-extraction site to 4-month. (time frame: 0 and 16 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 3 Jun 2021.