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

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.

Gingival Phenotype: Participants must be diagnosed with a thin phenotype of gingiva. This could be measured using a periodontal probe to assess the thickness of the gingiva, typically less than 1 mm is considered thin. In this area may be gingival recession 1,2 Cairo type.

Dental Health: Participants must have a sufficient number of teeth and bone support to undergo orthodontic treatment. A minimum number of teeth or specific dental conditions may be outlined to ensure that the treatment can be applied effectively.

Malocclusion: Participants must be diagnosed with malocclusion, specifically requiring correction in the mandibular incisors. The type and severity of malocclusion can be classified according to a recognized system such as the Angle classification or the Index of Orthodontic Treatment Need (IOTN).

Medical History: Participants must not have any contraindications to dental surgery or orthodontic treatment, such as uncontrolled diabetes, bisphosphonate therapy, or a history of radiation to the jaws.

Consent: Participants must be able to understand the nature of the study and provide informed consent to participate in the trial.

Availability: Participants must be available for the duration of the study and able to attend all scheduled appointments for treatment and follow-up assessments.

Periodontal Health: Participants should have good periodontal health or controlled periodontitis. This may involve a preliminary periodontal assessment, ensuring that there are no active diseases that could complicate the orthodontic treatment or surgical interventions.

Orthodontic Treatment Status: Participants must not have undergone any orthodontic treatment in the past six months to ensure that any previous treatments do not affect the outcomes of the current study.

No Concurrent Dental Procedures: Participants should not be undergoing concurrent dental procedures that could affect the outcomes of the orthodontic treatment, such as implants or extensive restorative work, not coordinated with the current treatment plan Radiographic Evaluation: Suitable candidates must have clear radiographic evidence that supports the diagnosis of malocclusion and allows for the assessment of alveolar bone volume and gingival thickness. This may include recent CBCT scans or panoramic radiographs.

Non-smoker Status:

Non-smokers or individuals who have smoke less than 10 cigarettes per day may be included to avoid the confounding effects of smoking on periodontal health and healing.

Exclusion criteria

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