Evaluating the Clinical Efficacy of Collagen Scaffold (Ossix VOLUMAX) With Piezo-Surgical Decortication in Enhancing Orthodontic Treatment Outcomes: A Randomized Controlled Trial

NCT07097714 | Recruiting DMC

• 1 other identifier: ДМ003
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Recent advances in orthodontic treatment have explored various materials to enhance treatment efficacy, particularly focusing on collagen scaffolds. Collagen, being a primary component of the bone matrix, has garnered attention for its biocompatibility, cell adhesion, and osteoconductivity properties. Studies have shown that collagen scaffolds undergo natural degradation, mimicking biological processes, and play a significant role in tissue engineering (International Journal of Implant Dentistry, 2023). This aligns with the growing interest in minimally invasive methods that accelerate orthodontic treatment and improve tissue regeneration. 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.

Conditions

Dental Crowding; Gingival Recession; Thin Phenotype

Keywords

Corticotomy, Soft Tissue Augmantation, Bone Augmentation, Ossix Volume, Collagene Scaffold, Orthodontics, Piezocision

Outcome Measures

Primary Outcomes (1)

• Increase in Gingival Thickness and Alveolar Bone Volume

  The primary endpoint is the quantifiable increase in gingival thickness and alveolar bone volume at the sites of orthodontic intervention. Gingival thickness will be defined as the distance from the gingival margin to the alveolar bone crest, and bone volume will be measured in cubic millimeters.

  Baseline measurements will be taken prior to the surgical intervention. Subsequent measurements will be taken at 1 month, 6 months, and 1 year post-surgery. Each measurement will be conducted by blinded examiners to maintain objectivity.

Secondary Outcomes (4)

• Risk Reduction of Gingival Recession

  Clinical periodontal probing and intraoral photographs will be used to measure and document changes in the gingival margin position.Measurements will be taken at baseline and at each subsequent follow-up visit, with comparison to pre-treatment levels.

• Decrease in Duration of Surgery

  Surgical duration will be precisely recorded in minutes by the operating team.

• Orthodontic Treatment Time

  Treatment duration will be monitored continuously, with records updated at each patient visit.

• Patient Satisfaction and Quality of Life

  Surveys will be administered at 6 months and 1 year post-treatment to capture both short- term and long-term satisfaction and quality of life.

Study Arms (2)

Intervention

EXPERIMENTAL

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):

Procedure: Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax)

Control

ACTIVE COMPARATOR

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

Procedure: control

Interventions

Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax) PROCEDURE

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.

Also known as: Volumax, Ribose cross-linked collagen scaffold, Ossix collagen matrix

Intervention

control PROCEDURE

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.

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Existing Periodontal Disease: Individuals with active periodontal disease or significant periodontal bone loss that contraindicates orthodontic treatment.

Sponsors & Collaborators

• NMSI DENTMASTER: lead

Study Sites (1)

Dental Clinic "Dental-Service" - Department of Oral and Maxillofacial Surgery, 77 S. Vanzetti Street

Novosibirsk, Novosibirsk Oblast, 630000, Russia

RECRUITING

MeSH Terms

Conditions

Crowding; Gingival Recession

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Central Study Contacts

Tatiana Gatilova Tatyana Andreevna

CONTACT

0079529399919; tagatilova@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention Group: 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.

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: July 31, 2025
• Study Start: June 25, 2024
• Primary Completion: September 25, 2025
• Study Completion (Estimated): September 25, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)