Nonterminal Premolar Needing ExtractionNCT06447844
OsteoGen Plug vs. Freeze-dried Bone Allograft With Collagen Barrier
A study testing OsteoGen Plug and BioGide in people with Nonterminal Premolar Needing Extraction, run by McGuire Institute at 9 sites in United States.
Trial summary
The study will be a multi-site, randomized, two-arm, controlled clinical trial using OsteoGen® Plug (Test) vs Freeze-dried Bone Allograft with collagen barrier (Control) for alveolar ridge preservation (ARP) in posterior extraction sites with intact buccal cortical plates. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonterminal Premolar Needing Extraction
- What is being tested?
- OsteoGen Plug and BioGide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 9 sitesUnited States
- Study dates
- 28 Mar 2024to 28 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 18 to 75-yrs of age.
- Subjects with a nonterminal premolar in need of extraction with intention to pursue implant replacement.
- Proposed treatment site must have intact buccal cortical plates > 1 mm in thickness (buccal bone dehiscence up to 25% root length is permissible). Apical lesions are acceptable which do not perforate the cortical plate).
- Proposed treatment site must have intact adjacent natural teeth. (no adjacent edentulous sites or implants).
- Subjects can provide self-care (oral hygiene) without disabilities requiring assistance with daily oral hygiene measures.
- Subjects will have read, understood, and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
- Subjects must be able and willing to follow study procedures and instructions.
Who cannot join
- Subjects with reported allergy or hypersensitivity to any of the products to be used in the study.
- Subjects with untreated / active periodontal disease.
- Subjects with vesiculobullous processes or other similar chronic oral lesions / conditions resulting in gingival irritation, discomfort/pain, or erosions.
- Tobacco/Cannabis users including cigarettes, vape, cigars, or smokeless tobacco.
- Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, cancer)
- Subjects who are lactating or pregnant or planning to become pregnant through their projected study duration.
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- Subjects who would require a tissue supported interim prosthesis i.e. acrylic / valplast RPD (tooth supported interim prostheses i.e. essix retainers are acceptable)
- Subjects with long-term history of oral bisphosphonates (> 10 years).
- Subjects with a history of intravenous bisphosphonates.
- Subjects taking medications known to affect gingival conditions. (e.g., hyperplasia)
- Subjects taking corticosteroids or immunosuppressants on a regular basis prior to baseline examination.
- Subjects taking anticoagulant medications such as warfarin or Plavix or Eliquis who are not medically cleared to hold medication prior to and during procedure.
- Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental).
- Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
McClain and Schallhorn Periodontics and Implant Dentistry
Aurora, Colorado, 80012-3260
The Perio Studio
Boston, Massachusetts, 02108
Colorado Gum Care
Broomfield, Colorado, 80020
Seven Lakes Periodontics
Fenton, Michigan, 48430
Perio Health Professionals
Houston, Texas, 77063-7229
WisNova Institute of Dental Specialists
Kenosha, Wisconsin, 53144-4292
Metro West Orthodontics and Periodontics
La Vista, Nebraska, 68128
Perio & Implant Associates of Middle TN
Nashville, Tennessee, 37215
Gulf Coast Periodontics
Victoria, Texas, 77904
About this study
Official title: OsteoGen® Plug vs Freeze-dried Bone Allograft With Collagen Barrier for Alveolar Ridge Preservation (ARP): A Randomized Controlled Trial
The study will be a multi-site, randomized, two-arm, controlled clinical trial using OsteoGen® Plug (Test) vs Freeze-dried Bone Allograft with collagen barrier (Control) for alveolar ridge preservation (ARP) in posterior extraction sites with intact buccal cortical plates.
Read the detailed description
After tooth extraction and debridement, sockets will be packed with either test product (OGP), or control product (BioGide). Subjects will then undergo follow-up assessments conducted at day 7 (+3 days), day 14 (+3 days), and day 30 (+3 days) for oral exam, PROs, AEs, and complication assessments. Subjects will undergo follow-up assessments conducted at day 60 (+3 days) and day 90 (+3 days), for oral exam, PROs, AEs, complication assessments, standardized PA radiographs. Subjects will undergo follow-up assessments conducted at day 120 (+3 days) for oral exam, PROs, AEs, complication assessments, standardized PA radiograph, intraoral scan, and CBCT.
OPTIONAL Subjects will undergo follow-up assessments conducted at day 135 (+14 days) for oral exam, AEs, complication assessments, histologic core procurement, additional grafting assessment, prosthetic driven implant placement assessment.
Subjects will undergo follow-up assessments conducted at day 143 (+5 days) for oral exam, AEs, end of study.
- Conditions
- Nonterminal Premolar Needing Extraction
- Being tested
- OsteoGen Plug, BioGide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteoGen PlugDevice
OsteoGen® Plug is contoured to fill the three roots of the socket. Plug is delivered dry into a thoroughly debrided and actively bleeding socket. The OsteoGen® Plug is condensed firmly into the socket.
BioGideDevice
BioGide is a resorbable collagen membrane
| Study group | Role | What they receive |
|---|---|---|
| OsteoGen Plug | Experimental | OsteoGen® Plug (OGP) is a combination of bovine achilles tendon collagen matrix sourced from Australia or New Zealand and bioactive resorbable calcium apatite crystals intended for ARP. It is provided to clinicians in 3 different sizes to be placed in extraction socket. Receives: Device: OsteoGen Plug |
| BioGide | Active comparator | This product is SOC treatment and will be used per packaging instructions. Receives: Device: BioGide |
What is being measured
The primary outcome is the main question the study is designed to answer.
New bone formation
new bone formation will be determined by Cone Beam Cat Scan (CBCT) at Day 120
Measured: 120 days
Secondary outcomes (1)
Change in ridge height compared to screening as determined by Cone Beam Cat Scan (CBCT)
two CBCTs will be compared, one from screening, the other at 120 days.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start28 Mar 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion28 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonterminal Premolar Needing ExtractionStudies 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
- a multi-site, randomized, two-arm, controlled clinical trial using OsteoGen® Plug (Test) vs Freeze-dried Bone Allograft with collagen barrier
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGuire Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Impladent LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447844
- Sponsor's protocol ID
- OGP2024-01
- Status last verified
- May 2026
- First submitted
- 29 May 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OsteoGen® Plug vs Freeze-dried Bone Allograft With Collagen Barrier for Alveolar Ridge Preservation (ARP): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06447844
- Acronym / sponsor ID
- OGP2024-01
- Conditions
- Nonterminal Premolar Needing Extraction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- McGuire InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Impladent LTD
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 28 Nov 2027 (estimated)
- First posted
- 7 Jun 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 study will be a multi-site, randomized, two-arm, controlled clinical trial using OsteoGen® Plug (Test) vs Freeze-dried Bone Allograft with collagen barrier (Control) for alveolar ridge preservation (ARP) in posterior extraction sites with intact buccal cortical plates.
Detailed description
After tooth extraction and debridement, sockets will be packed with either test product (OGP), or control product (BioGide). Subjects will then undergo follow-up assessments conducted at day 7 (+3 days), day 14 (+3 days), and day 30 (+3 days) for oral exam, PROs, AEs, and complication assessments. Subjects will undergo follow-up assessments conducted at day 60 (+3 days) and day 90 (+3 days), for oral exam, PROs, AEs, complication assessments, standardized PA radiographs. Subjects will undergo follow-up assessments conducted at day 120 (+3 days) for oral exam, PROs, AEs, complication assessments, standardized PA radiograph, intraoral scan, and CBCT.
OPTIONAL Subjects will undergo follow-up assessments conducted at day 135 (+14 days) for oral exam, AEs, complication assessments, histologic core procurement, additional grafting assessment, prosthetic driven implant placement assessment.
Subjects will undergo follow-up assessments conducted at day 143 (+5 days) for oral exam, AEs, end of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a multi-site, randomized, two-arm, controlled clinical trial using OsteoGen® Plug (Test) vs Freeze-dried Bone Allograft with collagen barrier
| Arm | Type | Receives |
|---|---|---|
| OsteoGen Plug | Experimental | Device: OsteoGen PlugOsteoGen® Plug (OGP) is a combination of bovine achilles tendon collagen matrix sourced from Australia or New Zealand and bioactive resorbable calcium apatite crystals intended for ARP. It is provided to clinicians in 3 different sizes to be placed in extraction socket. |
| BioGide | Active comparator | Device: BioGideThis product is SOC treatment and will be used per packaging instructions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects 18 to 75-yrs of age.
- Subjects with a nonterminal premolar in need of extraction with intention to pursue implant replacement.
- Proposed treatment site must have intact buccal cortical plates > 1 mm in thickness (buccal bone dehiscence up to 25% root length is permissible). Apical lesions are acceptable which do not perforate the cortical plate).
- Proposed treatment site must have intact adjacent natural teeth. (no adjacent edentulous sites or implants).
- Subjects can provide self-care (oral hygiene) without disabilities requiring assistance with daily oral hygiene measures.
Key exclusion criteria (14 listed)
- Subjects with reported allergy or hypersensitivity to any of the products to be used in the study.
- Subjects with untreated / active periodontal disease.
- Subjects with vesiculobullous processes or other similar chronic oral lesions / conditions resulting in gingival irritation, discomfort/pain, or erosions.
- Tobacco/Cannabis users including cigarettes, vape, cigars, or smokeless tobacco.
- Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, cancer)
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 |
|---|---|---|
| OsteoGen PlugOsteoGen® Plug is contoured to fill the three roots of the socket. Plug is delivered dry into a thoroughly debrided and actively bleeding socket. The OsteoGen® Plug is condensed firmly into the socket. | Device | OsteoGen Plug |
| BioGideBioGide is a resorbable collagen membrane | Device | BioGide |
Primary outcome
New bone formation
Time frame: 120 days
new bone formation will be determined by Cone Beam Cat Scan (CBCT) at Day 120
1 secondary outcome
Change in ridge height compared to screening as determined by Cone Beam Cat Scan (CBCT)
Time frame: 120 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OsteoGen Plug and BioGide in people with Nonterminal Premolar Needing Extraction, run by McGuire Institute at 9 sites 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 7 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
New bone formation (time frame: 120 days). 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 29 May 2026.