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Tooth Extraction Site HealingPhase 1/2RESTORENCT07078331

Safety and Performance, and Dose, of OsteoAdapt DE in Localized Alveolar Ridge Augmentations

A Phase 1/2 study testing OsteoAdapt DE (0.8 mg), OsteoAdapt DE (2.0 mg) and Xenograft Bone Graft in people with Tooth Extraction Site Healing and Ridge Augmentation, run by Theradaptive, Inc at 6 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study's objective is to evaluate OsteoAdapt DE's safety and performance in comparison to Xenograft particulate bone graft for alveolar ridge augmentation. Additionally, the study aims to optimize OsteoAdapt DE dosing for future studies by assessing two concentrations: a low dose (0.8 mg/cc) and a high dose (2.0… Read more about this study

Who is it for?
Ages 22 years and older
What is being tested?
OsteoAdapt DE (0.8 mg), OsteoAdapt DE (2.0 mg) and Xenograft Bone Graft
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
6 sitesin 2 countries
Study dates
17 Jul 2025to 31 Dec 2026
Phase
Phase 1/2
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 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 22 or older at the time of signing informed consent
  • Subject requires extraction of a single tooth due to extensive carious lesions, prosthetic or endodontic failure, root fracture, or other reasons with dental implant treatment planned at the site
  • Tooth root in position allowing a bone core sample to be harvested within the former socket
  • 6mm of alveolar bone height without impinging on the maxillary sinus or inferior alveolar canal
  • Dehiscence of ≤ 2 mm on the buccal bony wall at the time of extraction
  • Presence of other socket walls, mesial, distal and lingual walls
  • The subject is willing and able to be present for routine follow up visits, comply with postoperative management program, and is able to understand and sign the informed consent form
  • Willing to use a reliable method of contraception (for woman of childbearing potential and males with a partner who is of childbearing potential)

Who cannot join

  • Active localized or systemic infection
  • Untreated periodontal disease
  • Presence of a fenestration larger than 3 mm in diameter in the buccal wall at the time of extraction
  • Inadequate bone dimensions or restorative space to place a dental implant
  • The subject uses, or has used within 30 45 days of surgery, tobacco or nicotine or is prescribed steroids such as cortisone
  • Presence or history of malignancy (excludes surgically resected skin squamous cell or basal cell carcinoma), radiotherapy, or chemotherapy for any malignancy within the last 5 years. History of malignancy may include multiple exostoses syndrome (also known as multiple osteochondromas syndrome), an inherited condition associated with bumps of cartilage on the bones, which has been associated with an increased risk of chondrosarcoma); individuals with hereditary cancer syndromes are excluded. Examples of hereditary cancer syndromes are hereditary breast and ovarian cancer syndrome, Li-Fraumeni syndrome, Cowden syndrome, and Lynch syndrome. Also called family cancer syndrome and inherited cancer syndrome individuals who have undergone any transplant surgery and are on immunosuppressant therapy
Show all 16Show fewer
  • Has a history of any endocrine or metabolic disorder known to affect osteogenesis (e.g.: Paget's disease, renal osteodystrophy, Ehler-Danlos syndrome, or osteogenesis imperfecta)
  • Insulin dependent diabetes
  • History of exposure to any recombinant proteins or peptides used for bone formation (i.e., Infuse Bone Graft, AUGMENT Bone Graft, GEM21S, i-FACTOR Peptide Enhanced Bone Graft, or PepGen P-15 Synthetic Bone Graft)
  • Hypersensitivity or allergy to any components of the study treatments including, but not limited to, bone morphogenetic proteins (BMPs); tricalcium phosphate (TCP); PLGA polymer
  • History of any allergy resulting in anaphylaxis
  • Treatment with an investigational therapy (drug, device, and/or biologic) within 120 days (or 5 half-lives, whichever is greater) prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment; prior or planned use of rhBMP-2
  • Pregnant at final Screening evaluation prior to Day 1 pre-procedure or interested in trying to conceive a child (both females and males) in the next 12 months or nursing
  • Any condition that would interfere with the subject's ability to comply with study instructions or prohibit Radiographic assessments that might confound the interpretation of the study or put the subject at risk
  • Patients taking any drug known to interfere with bone/soft tissue healing. See "Medication protocol" section of the protocol.
  • Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Israel4 sites

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Assuta Medical Center

    Tel Aviv, 6971028

  • Sheba Medical Center

    Tel HaShomer, 5265601

Other trials in Israel

Armenia2 sites

  • Armenia Medical Center

    Yerevan, 0078

  • Medline Clinic

    Yerevan, 0078

Other trials in Armenia

About this study

Official title: A Prospective, Multi Center, Single-Blinded, Randomized, Controlled Study to Evaluate the Safety and Performance, and Dose, of OsteoAdapt DE in Localized Alveolar Ridge Augmentations for Defects Associated With Extraction Sockets - Feasibility Study

This study's objective is to evaluate OsteoAdapt DE's safety and performance in comparison to Xenograft particulate bone graft for alveolar ridge augmentation. Additionally, the study aims to optimize OsteoAdapt DE dosing for future studies by assessing two concentrations: a low dose (0.8 mg/cc) and a high dose (2.0 mg/cc).

Read the detailed description

Prospective, Multi Center, Single-Blinded, Randomized, Controlled Study to Evaluate the Safety and Performance, and Dose, of OsteoAdapt DE in Localized Alveolar Ridge Augmentations for Defects Associated with Extraction Sockets - Feasibility Study.

Patients requiring a single tooth extraction (with the intent of placing a dental implant into the regenerated bone in the extraction socket) who signed the consent form and are found eligible for the study (meet the inclusion criteria and none of the exclusion criteria) will be randomized into one of 3 study Arms at a 1:1:1 ratio prior to the extraction procedure:

Study Arm 1 - Investigational (~15 subjects): OsteoAdapt DE with 0.8mg AMP-2 per cc of ReBOSSIS-J packed inside of the extraction socket.

Study Arm 2 - Investigational (~15 subjects): OsteoAdapt DE with 2.0mg AMP2 per cc of ReBOSSIS-J packed inside of the extraction socket.

Study Arm 3 - Control (~15 subjects): Xenograft particulate bone graft packed inside of the extraction socket (SOC).

The Subjects will be blinded to their arm allocation whereas the treating physician will be unblinded (Single blinded study). Grafting of the prepared socket will be performed at the time of tooth extraction, and all extraction sockets will be covered with a resorbable collagen membrane (e.g. BioGide from Geistlich) prior to reapproximation of buccal and lingual flaps. Primary closure of the extraction socket is not required.

Being tested
OsteoAdapt DE (0.8 mg), OsteoAdapt DE (2.0 mg), Xenograft Bone Graft

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OsteoAdapt DE (0.8 mg)Device

    Procedure of single tooth extraction and grafting along with related data collection:

    Implanted OsteoAdapt DE bone graft (0.8 mg) by a trained and qualified study investigator per the IFU, IB and CIP guidelines

  • OsteoAdapt DE (2.0 mg)Device

    Procedure of single tooth extraction and grafting along with related data collection:

    Implanted OsteoAdapt DE bone graft (2.0 mg) by a trained and qualified study investigator per the IFU, IB and CIP guidelines

  • Xenograft Bone GraftDevice

    Procedure of single tooth extraction and grafting along with related data collection:

    Implanted xenograft bone graft by a trained and qualified study investigator per the IFU, IB and CIP guidelines

Study groups in NCT07078331
Study groupRoleWhat they receive
Low Dose OsteoAdapt DEExperimentalOsteoAdapt DE with 0.8 mg AMP2 per cc of ReBOSSIS-J packed inside of the extraction socket
Receives: Device: OsteoAdapt DE (0.8 mg)
High Dose OsteoAdapt DEExperimentalOsteoAdapt DE with 2.0 mg AMP2 per cc of ReBOSSIS-J packed inside of the extraction socket
Receives: Device: OsteoAdapt DE (2.0 mg)
Control (Xenograft)Active comparatorXenograft particulate bone graft packed inside of the extraction socket (SOC).
Receives: Device: Xenograft Bone Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful placement of a dental implant with primary stability (>25 N cm)

    Measured: 6 months

  2. Rates of serious adverse events related to the grafting material and / or grafting procedure

    Measured: 6 months

  3. Occurrence of any unplanned additional procedures at the implantation site related to the grafting material or grafting procedure

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start17 Jul 2025
  3. Primary completion1 Apr 2026
  4. Study completion31 Dec 2026 (estimated)

Resources

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 1/2
Primary purpose
Device feasibility
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07078331
Sponsor's protocol ID
OADE.D1.ISR
Acronym
RESTORE
Status last verified
Apr 2026
First submitted
9 Jul 2025
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OsteoAdapt DE (0.8 mg), OsteoAdapt DE (2.0 mg) and Xenograft Bone Graft in people with Tooth Extraction Site Healing and Ridge Augmentation, run by Theradaptive, Inc at 6 sites in 2 countries.

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 8 inclusion and 16 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Israel, Armenia. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Successful placement of a dental implant with primary stability (>25 N cm) (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT07078331.

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 6 Apr 2026.

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