Clinical trial NCT05838651: Socket Preservation With BioHorizon's Striate+ Membrane and MinerOss X Plug
Official title: The Combination of BioHorizon's Striate+ Membrane in Conjunction With MinerOss X Plug for Providing Hard Tissue Regeneration in Socket Preservation Procedure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Socket Preservation
Keywords: Bone Graft
Membrane
Extraction
Lead sponsor: Harvard School of Dental Medicine
Sponsor class: OTHER
Collaborators: name: Camlog Oral Reconstruction Foundation
name: BioHorizons, Inc.
First posted: 2023-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Clinical Trial
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: radiographic ridge width
timeFrame: 12 months
Secondary outcomes:
measure: gingival thickness
timeFrame: 12 months
measure: radiographic alveolar height
timeFrame: 12 months
measure: clinical alveolar height and width
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Harvard School of Dental Medicine
name: David M Kim, DDS, DMSc
role: PRINCIPAL_INVESTIGATOR
References: