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

NCT07078331 | Recruiting Phase 1 FDA Device

• 1 other identifier: OADE.D1.ISR
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 6

Brief 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 mg/cc).

Conditions

Ridge Augmentation; Tooth Extraction Site Healing; Bone Graft

Outcome Measures

Primary Outcomes (3)

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

  6 months

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

  6 months

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

  6 months

Study Arms (3)

Low Dose OsteoAdapt DE

EXPERIMENTAL

OsteoAdapt DE with 0.8 mg AMP2 per cc of ReBOSSIS-J packed inside of the extraction socket

Device: OsteoAdapt DE (0.8 mg)

High Dose OsteoAdapt DE

EXPERIMENTAL

OsteoAdapt DE with 2.0 mg AMP2 per cc of ReBOSSIS-J packed inside of the extraction socket

Device: OsteoAdapt DE (2.0 mg)

Control (Xenograft)

ACTIVE COMPARATOR

Xenograft particulate bone graft packed inside of the extraction socket (SOC).

Device: Xenograft Bone Graft

Interventions

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

Low Dose OsteoAdapt DE

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

High Dose OsteoAdapt DE

Xenograft Bone Graft DEVICE

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

Control (Xenograft)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• mm 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)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Theradaptive, Inc: lead

Study Sites (6)

Armenia Medical Center

Yerevan, 0078, Armenia

RECRUITING

Medline Clinic

Yerevan, 0078, Armenia

RECRUITING

Hadassah Medical Center

Jerusalem, 9112001, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, 4941492, Israel

RECRUITING

Assuta Medical Center

Tel Aviv, 6971028, Israel

RECRUITING

Sheba Medical Center

Tel Litwinsky, 5265601, Israel

RECRUITING

Central Study Contacts

Jonathan Elsner, PhD, MBA

CONTACT

(240) 798-9014; jonathan.elsner@theradaptive.com

Lelia Halloran, MSc

CONTACT

lelia.halloran@theradaptive.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The Subjects will be blinded to their arm allocation whereas the treating physician will be unblinded (Single blinded study)
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 22, 2025
• Study Start: July 17, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

IL (4); AR (2)