Socket Preservation With BioHorizon's Striate+ Membrane and MinerOss X Plug

NCT05838651 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IRB23-0179
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Socket Preservation

Keywords

Bone Graft; Membrane; Extraction

Outcome Measures

Primary Outcomes (1)

• radiographic ridge width

  To provide detailed evidence of new bone formation in patients undergoing socket preservation procedures.

  12 months

Secondary Outcomes (3)

• gingival thickness

  12 months

• radiographic alveolar height

  12 months

• clinical alveolar height and width

  12 months

Study Arms (2)

Bone Graft Alone

ACTIVE COMPARATOR

Socket preservation sites with bone graft (MinerOss® X Plug) alone without complete flap closure (secondary intention healing) (n=10)

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)

Device: MinerOss® X Plug; Device: Striate+ Membrane

Interventions

MinerOss® X Plug DEVICE

A xenograft composed of 80% bovine cancellous particulate and 20% bovine Type I collagen.

Bone Graft + Membrane; Bone Graft Alone

Striate+ Membrane DEVICE

A non-crosslinked collagen covering used to keep bacteria out and hold the bone graft in place.

Bone Graft + Membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.
• 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.

Sponsors & Collaborators

• Harvard School of Dental Medicine: lead
• Camlog Oral Reconstruction Foundation: collaborator
• BioHorizons, Inc.: collaborator

Study Sites (1)

Harvard School of Dental Medicine

Boston, Massachusetts, 02115, United States

Location

Study Officials

• David M Kim, DDS, DMSc

  Harvard School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Oral Medicine, Infection, and Immunity

Model Details: Randomized Control Clinical Trial

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 1, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)