Evaluating the Clinical Efficacy of Collagen Scaffold (Ossix VOLUMAX) With Piezo-Surgical Decortication in Enhancing Orthodontic Treatment Outcomes: A Randomized Controlled Trial
NCT ID: NCT07097714
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2024-06-25
2026-09-25
Brief Summary
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In this context, the application of collagen scaffolds, such as Ossix VOLUMAX, in conjunction with piezo-surgical decortication, presents a novel approach. This study aims to build upon the existing knowledge, exploring the efficacy of collagen scaffolds in enhancing orthodontic treatment outcomes, especially in patients with specific dental conditions like a thin gingival phenotype and malocclusion. The study\'s hypothesis is grounded in the promising properties of collagen-based materials in dental and orthodontic applications, as evidenced by recent research in the field.
Detailed Description
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The application of a Collagen Scaffold (Ossix VOLUMAX) in conjunction with piezo- surgical decortication enhances the efficacy of orthodontic treatment by increasing the thickness of gingiva and volume of alveolar bone in adults with a thin phenotype of gingiva and malocclusion, particularly in the mandibular incisors, more effectively than piezo- surgical decortication with a connective tissue graft alone. This combined treatment also reduces morbidity, decreases the risk of gingival recessions, and shortens the duration of surgery compared to the control group.
Study Groups:
In this clinical trial, the participants are divided into two groups to compare the outcomes of different surgical interventions in conjunction with orthodontic treatment:
Intervention Group:
This group will receive the novel treatment combination. Participants in this arm will undergo piezocisions, a minimally invasive surgical technique that aids in orthodontic tooth movement by creating vertical corticotomy grooves in the alveolar bone to facilitate its remodeling. Along with this procedure, a Collagen Scaffold (specifically, Ossix VOLUMAX) will be applied. The scaffold is likely designed to support the regeneration of bone and soft tissue, potentially enhancing the effects of the decortication and improving clinical outcomes such as bone volume and gingival thickness.
Control Group:
The control group will receive piezocisions will be performed in strategic locations to accelerate as well ensuring that any effects due to the decortication process itself are not attributed to the novel treatment.Instead of the collagen scaffold, participants of this group will receive a Deepitelized Free Gingival Graft (DFGG), which is a well-established technique for increasing a soft tissue volume and treating gingival recession. The DFGG serves as a standard comparison to evaluate the added benefit, if any of the collagen scaffold used in the intervention group.
Treatment methods:
Intervention Group: Collagen Scaffold with Piezocision
Piezcision:
Procedure: Decortication in alveolar bone was done using piezotome handpiece with piezo surgical knife, precise and selective vertical corticotomy grooves which are about 1.5-2 mm in depth will be made in the cortical bone around teeth that are targeted for movement in the interradicular area.
Technique: A minimally invasive full thickness flap will be raised to expose the alveolar bone. Vertical corticotomy grooves will be performed in strategic locations to accelerate orthodontic tooth movement.
Parameters: Vertical corticotomy grooves will be performed in strategic locations in the interradicular area which are about 1.5-2 mm in depth by gently working around the root of the tooth without damaging it, and distribution of the cuts will be standardized based on the best available evidence and will be documented for each patient.
Collagen Scaffold (Osssix VOLUMAX):
Application: After the decortication, the collagen scaffold will be applied directly onto the bone surface.
Characteristics: The scaffold is composed sugar cross-linked of byoresobable collagene 1 type (porcine), 1.5 mm thikness, resorption time 4 month.
Post-Operative Care: Standardized instructions will be provided for home care, including oral hygiene and medication, if any, to support scaffold integration.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Participants in this arm will undergo piezocisions, a minimally invasive surgical technique that aids in orthodontic tooth movement by creating vertical corticotomy grooves in the alveolar bone to facilitate its remodeling. Along with this procedure, a Collagen Scaffold will be applied. The scaffold is likely designed to support the regeneration of bone and soft tissue, potentially enhancing the effects of the decortication .
The control group will receive piezocisions will be performed in strategic locations to accelerate as well ensuring that any effects due to the decortication process itself are not attributed to the novel treatment.Instead of the collagen scaffold, participants of this group will receive a Deepitelized Free Gingival Graft (DFGG), which is a well-established technique for increasing a soft tissue volume and treating gingival recession.
OTHER
DOUBLE
Study Groups
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Intervention
Description of Arm:
This group will receive the novel treatment combination. Participants will undergo piezocision-a minimally invasive surgical technique that creates vertical corticotomy grooves in the alveolar bone to stimulate bone remodeling and accelerate orthodontic tooth movement. In addition, a ribose cross-linked collagen matrix (Ossix® Volumax) will be applied over the decorticated bone surface. All participants are undergoing active orthodontic treatment with fixed appliances prior to the surgical procedure.
Intervention Name:
Procedure/Surgery: Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax)
Intervention Description:
A minimally invasive full-thickness flap will be elevated to expose the alveolar bone. Vertical corticotomy grooves (piezocision) will be performed in strategic locations. The collagen matrix (Ossix® Volumax) will be trimmed and applied over the exposed decorticated bone to support bone and soft tissue regeneration.
Other Name(s):
Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax)
A full-thickness mucoperiosteal flap will be elevated to expose the alveolar bone. Vertical corticotomy grooves (piezocision) will be created in strategic locations to accelerate orthodontic tooth movement. The Ossix® Volumax collagen matrix will be trimmed and applied directly onto the decorticated bone surface to support bone regeneration and soft tissue augmentation.
Control
Description of Arm:
This group will receive the control treatment. Piezocision will be performed similarly to the experimental group, creating vertical corticotomy grooves to accelerate tooth movement. However, instead of a collagen matrix, participants will receive a deepithelialized free gingival graft (DFGG) harvested from the palatal mucosa. This well-established technique is commonly used to increase gingival thickness and volume and serves as a comparator for evaluating the potential added benefit of the collagen scaffold.
Intervention Name:
Procedure/Surgery: Piezocision with deepithelialized free gingival graft (DFGG)
Intervention Description:
A full-thickness mucoperiosteal flap will be elevated to expose the alveolar bone. Vertical corticotomy grooves will be created (piezocision) in strategic locations to accelerate orthodontic tooth movement. A deepithelialized free gingival graft harvested from the palate will then be placed and stabilized over the decorticated bone
control
A minimally invasive full thickness flap will be raised to expose the alveolar bone. Vertical corticotomy grooves will be performed in strategic locations to accelerate orthodontic tooth movement. The Deepitelized Free Gingival Graft (DFGG) will be placed and secured over the areas of decortication to promote soft tissue healing and augmentation.
Interventions
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Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax)
A full-thickness mucoperiosteal flap will be elevated to expose the alveolar bone. Vertical corticotomy grooves (piezocision) will be created in strategic locations to accelerate orthodontic tooth movement. The Ossix® Volumax collagen matrix will be trimmed and applied directly onto the decorticated bone surface to support bone regeneration and soft tissue augmentation.
control
A minimally invasive full thickness flap will be raised to expose the alveolar bone. Vertical corticotomy grooves will be performed in strategic locations to accelerate orthodontic tooth movement. The Deepitelized Free Gingival Graft (DFGG) will be placed and secured over the areas of decortication to promote soft tissue healing and augmentation.
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
18 Years
50 Years
ALL
No
Sponsors
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NMSI DENTMASTER
OTHER
Responsible Party
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Locations
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Dental Clinic "Dental-Service" - Department of Oral and Maxillofacial Surgery, 77 S. Vanzetti Street
Novosibirsk, Novosibirsk Oblast, Russia
Countries
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Central Contacts
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Facility Contacts
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Tatiana Andreevna Gatilova, DDS
Role: primary
Tatiana Andreevna Gatilova, DDS
Role: backup
Other Identifiers
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ДМ003
Identifier Type: -
Identifier Source: org_study_id