Socket PreservationNCT05838651
Socket Preservation With BioHorizon's Striate+ Membrane and MinerOss X Plug
A study testing MinerOss® X Plug and Striate+ Membrane in people with Socket Preservation, run by Harvard School of Dental Medicine at 1 site in United States.
Trial summary
The primary objective of this proposed clinical trial is to provide detailed comparison and evidence of new bone formation in patients undergoing socket preservation utilizing MinerOss® X Plug with and without Striate+ Membrane to maintain ridge dimension after a tooth extraction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Socket Preservation
- What is being tested?
- MinerOss® X Plug and Striate+ Membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to May 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, between 20-70 years of age, who requests dental implant treatment option for rehabilitation.
- Subjects who are willing to sign an informed consent, participate and return for follow-up visits.
- Subjects without significant medical history and currently not on medications that might complicate our results.
- Has a single-rooted tooth (upper and lower premolars to premolars) requiring extraction with two neighboring teeth on either side of it and intact bony walls.
Who cannot join
- Subjects who do not meet all the inclusion criteria or who will not cooperate with the protocol schedule.
- Subjects who received and failed a previously placed dental implant.
- Subjects who require additional ridge augmentation procedure in the area to achieve adequate bone volume for the placement of dental implants.
- Subjects who have significant untreated periodontal disease, caries, infection or chronic inflammation in the oral cavity within two adjacent tooth positions of the clinical trial area.
- Subjects who have used nicotine-containing products within 3 weeks prior to surgery.
- Subjects who are insulin-dependent diabetic or if their Hgb1c levels > 6.5%.
Show all 14Show fewer
- Subjects who have had a history of malignancy within the past 5 years (except for basal or squamous cell carcinoma of the skin or in situ cervical carcinoma).
- Subjects who are nursing or pregnant.
- Subjects who are presently taking medications (except estrogen/progesterone therapy) or those who are undergoing treatment that in known to have an effect on bone turnover.
- Subjects who have diseases that affect bone metabolism (excluding idiopathic osteoporosis).
- Subjects with a history of an autoimmune disease, documented allergy or multiple allergies to any component of the agents used in this study.
- Difficult extraction with potential disruption / fracture of the alveolar bone.
- Acutely infected defect site.
- Subjects who are presently taking blood thinner medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard School of Dental Medicine
Boston, Massachusetts, 02115
About this study
Official title: The Combination of BioHorizon's Striate+ Membrane in Conjunction With MinerOss X Plug for Providing Hard Tissue Regeneration in Socket Preservation Procedure
The primary objective of this proposed clinical trial is to provide detailed comparison and evidence of new bone formation in patients undergoing socket preservation utilizing MinerOss® X Plug with and without Striate+ Membrane to maintain ridge dimension after a tooth extraction.
Read the detailed description
The primary objective of this proposed clinical trial is to provide detailed comparison and evidence of new bone formation in patients undergoing socket preservation utilizing two widely accepted treatment modalities that are used to maintain ridge dimension after a tooth extraction.
The specific aims of the study are:
- To demonstrate the efficacy of a Striate+ membrane in conjunction with a bone graft substitute for providing hard tissue regeneration in the socket preservation procedure.
- To determine the safety of Striate+ membrane when primary flap closure over the membrane is not achieved in the socket preservation procedure.
- To provide detailed evidence of new bone formation in patients undergoing socket preservation procedures by means of clinical, radiographic, histologic, and histomorphometric analyses.
It is currently unclear if one treatment is more effective than the other. The two treatments being compared are:
Treatment 1: Socket preservation sites with bone graft (MinerOss® X Plug) alone without complete flap closure (secondary intention healing) (n=10) Treatment 2: Socket preservation sites with bone graft (MinerOss® X Plug) and a non-crosslinked collagen membrane without complete flap closure (secondary intention healing) (n=10)
MinerOss® X Plug: A xenograft composed of 80% bovine cancellous particulate and 20% bovine Type I collagen. The 20% collagen prevents particulate migration.
Striate+ Membrane: A non-crosslinked collagen covering used to keep bacteria out and hold the bone graft in place.
Secondary intention healing (without complete flap closure): The wound edges are not brought together (i.e. knee scrape).
- Conditions
- Socket Preservation
- Being tested
- MinerOss® X Plug, Striate+ Membrane
- Keywords
- Bone Graft, Membrane, Extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinerOss® X PlugDevice
A xenograft composed of 80% bovine cancellous particulate and 20% bovine Type I collagen.
Striate+ MembraneDevice
A non-crosslinked collagen covering used to keep bacteria out and hold the bone graft in place.
| Study group | Role | What they receive |
|---|---|---|
| Bone Graft Alone | Active comparator | Socket preservation sites with bone graft (MinerOss® X Plug) alone without complete flap closure (secondary intention healing) (n=10) Receives: Device: MinerOss® X Plug |
| Bone Graft + Membrane | Experimental | Socket preservation sites with bone graft (MinerOss® X Plug) and a non-crosslinked collagen membrane without complete flap closure (secondary intention healing) (n=10) Receives: Device: MinerOss® X Plug; Device: Striate+ Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic ridge width
To provide detailed evidence of new bone formation in patients undergoing socket preservation procedures.
Measured: 12 months
Secondary outcomes (3)
gingival thickness
To assess soft tissue changes.
Measured: 12 months
radiographic alveolar height
To assess radiographic hard tissue changes.
Measured: 12 months
clinical alveolar height and width
To assess clinical hard tissue changes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 May 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Socket PreservationStudies 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
- Randomized Control Clinical Trial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Dental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Camlog Oral Reconstruction Foundation, BioHorizons, Inc.
- Responsible party
- Principal investigator, Chia-Yu Chen, Harvard School of Dental Medicine
- Investigators
- David M Kim, DDS, DMSc, Principal investigator, Harvard School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838651
- Sponsor's protocol ID
- IRB23-0179
- Status last verified
- Jan 2025
- First submitted
- 20 Apr 2023
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Khehra A, Montesano J, Tavelli L, Chen CY, Kim DM. Outcomes of alveolar ridge preservation using a collagenated bovine bone xenograft: A randomized controlled trial. J Periodontol. 2026 Jun;97(6):1157-1169. doi: 10.1002/jper.70036. Epub 2025 Dec 29.
PubMed 41457808
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of BioHorizon's Striate+ Membrane in Conjunction With MinerOss X Plug for Providing Hard Tissue Regeneration in Socket Preservation Procedure
- ClinicalTrials.gov ID
- NCT05838651
- Acronym / sponsor ID
- IRB23-0179
- Conditions
- Socket Preservation
- Keywords
- Bone Graft, Membrane, Extraction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Harvard School of Dental MedicineUniversity, hospital or other
- Collaborators
- Camlog Oral Reconstruction Foundation, BioHorizons, Inc.
- Study start
- 1 May 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 1 May 2023 (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 primary objective of this proposed clinical trial is to provide detailed comparison and evidence of new bone formation in patients undergoing socket preservation utilizing MinerOss® X Plug with and without Striate+ Membrane to maintain ridge dimension after a tooth extraction.
Detailed description
The primary objective of this proposed clinical trial is to provide detailed comparison and evidence of new bone formation in patients undergoing socket preservation utilizing two widely accepted treatment modalities that are used to maintain ridge dimension after a tooth extraction.
The specific aims of the study are:
- To demonstrate the efficacy of a Striate+ membrane in conjunction with a bone graft substitute for providing hard tissue regeneration in the socket preservation procedure.
- To determine the safety of Striate+ membrane when primary flap closure over the membrane is not achieved in the socket preservation procedure.
- To provide detailed evidence of new bone formation in patients undergoing socket preservation procedures by means of clinical, radiographic, histologic, and histomorphometric analyses.
It is currently unclear if one treatment is more effective than the other. The two treatments being compared are:
Treatment 1: Socket preservation sites with bone graft (MinerOss® X Plug) alone without complete flap closure (secondary intention healing) (n=10) Treatment 2: Socket preservation sites with bone graft (MinerOss® X Plug) and a non-crosslinked collagen membrane without complete flap closure (secondary intention healing) (n=10)
MinerOss® X Plug: A xenograft composed of 80% bovine cancellous particulate and 20% bovine Type I collagen. The 20% collagen prevents particulate migration.
Striate+ Membrane: A non-crosslinked collagen covering used to keep bacteria out and hold the bone graft in place.
Secondary intention healing (without complete flap closure): The wound edges are not brought together (i.e. knee scrape).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Bone Graft Alone | Active comparator | Device: MinerOss® X PlugSocket preservation sites with bone graft (MinerOss® X Plug) alone without complete flap closure (secondary intention healing) (n=10) |
| Bone Graft + Membrane | Experimental | Device: MinerOss® X Plug, Device: Striate+ MembraneSocket preservation sites with bone graft (MinerOss® X Plug) and a non-crosslinked collagen membrane without complete flap closure (secondary intention healing) (n=10) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, between 20-70 years of age, who requests dental implant treatment option for rehabilitation.
- Subjects who are willing to sign an informed consent, participate and return for follow-up visits.
- Subjects without significant medical history and currently not on medications that might complicate our results.
- Has a single-rooted tooth (upper and lower premolars to premolars) requiring extraction with two neighboring teeth on either side of it and intact bony walls.
Key exclusion criteria (14 listed)
- Subjects who do not meet all the inclusion criteria or who will not cooperate with the protocol schedule.
- Subjects who received and failed a previously placed dental implant.
- Subjects who require additional ridge augmentation procedure in the area to achieve adequate bone volume for the placement of dental implants.
- Subjects who have significant untreated periodontal disease, caries, infection or chronic inflammation in the oral cavity within two adjacent tooth positions of the clinical trial area.
- Subjects who have used nicotine-containing products within 3 weeks prior to 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 |
|---|---|---|
| MinerOss® X PlugA xenograft composed of 80% bovine cancellous particulate and 20% bovine Type I collagen. | Device | Bone Graft + Membrane, Bone Graft Alone |
| Striate+ MembraneA non-crosslinked collagen covering used to keep bacteria out and hold the bone graft in place. | Device | Bone Graft + Membrane |
Primary outcome
radiographic ridge width
Time frame: 12 months
To provide detailed evidence of new bone formation in patients undergoing socket preservation procedures.
3 secondary outcomes
gingival thickness
Time frame: 12 months
radiographic alveolar height
Time frame: 12 months
clinical alveolar height and width
Time frame: 12 months
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 3 Jan 2025.
- Derived from this study: PubMed 41457808Khehra A, Montesano J, Tavelli L, Chen CY, Kim DM. Outcomes of alveolar ridge preservation using a collagenated bovine bone xenograft: A randomized controlled trial. J Periodontol. 2026 Jun;97(6):1157-1169. doi: 10.1002/jper.70036. Epub 2025 Dec 29.
- Individual participant dataSharing planned: No
Related trials for Socket Preservation
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
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Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
Surgery, Oral
RecruitingPhase 4
Biotivity A-C Membrane Socket Preservation Study
Alveolar Ridge Preservation
Active, not recruiting
Vallomix Socket Preservation Study
Alveolar Ridge Augmentation
Not yet recruiting
Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
Alveolar Bone Loss, Tooth Loss / Rehabilitation
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.
David M Kim, DDS, DMSc principal investigator
Harvard School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MinerOss® X Plug and Striate+ Membrane in people with Socket Preservation, run by Harvard School of Dental Medicine 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 4 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 3 Jan 2025. 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?
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?
radiographic ridge width (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05838651, which also lists 1 linked publication.
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 Jan 2025.