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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Socket Preservation
• Intervention / Treatment: Device: MinerOss® X Plug; Device: Striate+ Membrane

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:

1. 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.
2. To determine the safety of Striate+ membrane when primary flap closure over the membrane is not achieved in the socket preservation procedure.
3. 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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chia-Yu Chen, DDS, DMSc; Phone Number: 857-576-0279; Email: chia-yu_chen@hsdm.harvard.edu
• Study Contact Backup: Name: David M Kim, DDS, DMSc; Phone Number: 617-432-1472; Email: dkim@hsdm.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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%.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bone Graft Alone; Socket preservation sites with bone graft (MinerOss® X Plug) alone without complete flap closure (secondary intention healing) (n=10)	Device: MinerOss® X Plug; A xenograft composed of 80% bovine cancellous particulate and 20% bovine Type I collagen.
Experimental: Bone Graft + Membrane; 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; A xenograft composed of 80% bovine cancellous particulate and 20% bovine Type I collagen.; Device: Striate+ Membrane; A non-crosslinked collagen covering used to keep bacteria out and hold the bone graft in place.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiographic ridge width	To provide detailed evidence of new bone formation in patients undergoing socket preservation procedures.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gingival thickness	To assess soft tissue changes.	12 months
radiographic alveolar height	To assess radiographic hard tissue changes.	12 months
clinical alveolar height and width	To assess clinical hard tissue changes.	12 months

Collaborators and Investigators

• Sponsor: Harvard School of Dental Medicine
• Collaborators: BioHorizons, Inc.; Camlog Oral Reconstruction Foundation
• Investigators: Principal Investigator: David M Kim, DDS, DMSc, Harvard School of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Membrane; Bone Graft; Extraction
• Other Study ID Numbers: IRB23-0179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes