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.
Hypothesis: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
70
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.
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.
Dental Clinic "Dental-Service" - Department of Oral and Maxillofacial Surgery, 77 S. Vanzetti Street
Novosibirsk, Novosibirsk Oblast, Russia
RECRUITINGIncrease 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.
Time frame: 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.
Risk Reduction of Gingival Recession
A decrease in the incidence of gingival recession post-treatment, characterized by the exposure of the roots of the teeth as measured from the cementoenamel junction (CEJ) to the gingival margin.
Time frame: 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
This refers to the actual time taken to complete the surgical aspect of the treatment, from the initial incision to the final suture or equivalent closing procedure.
Time frame: Surgical duration will be precisely recorded in minutes by the operating team.
Orthodontic Treatment Time
The time required from the initiation of orthodontic appliance placement to the achievement of the desired dental alignment and occlusion
Time frame: Treatment duration will be monitored continuously, with records updated at each patient visit.
Patient Satisfaction and Quality of Life
This endpoint assesses the patient's subjective satisfaction with the treatment outcomes and the impact on their quality of life. Measurement Tools: Validated questionnaires such as the Oral Health Impact Profile (OHIP) and patient satisfaction surveys will be utilized.
Time frame: 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.
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