Using a collagen scaffold (Ossix VOLUMAX) with piezo-surgical decortication to improve orthodontic outcomes in adults with thin gums

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

This study tests whether adding a collagen scaffold (Ossix VOLUMAX) to minimally invasive piezo-surgical decortication helps adults with thin gingiva and lower front tooth crowding gain thicker gums, more bone, less recession, and faster orthodontic correction.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: NMSI DENTMASTER (other)
• Drugs / interventions: radiation
• Locations: 1 site (Novosibirsk, Novosibirsk Oblast)
• Trial ID: NCT07097714 on ClinicalTrials.gov

What this trial studies

Adult patients with a thin gingival phenotype and malocclusion affecting the mandibular incisors are randomized to one of two surgical approaches performed alongside orthodontic treatment. The intervention arm receives piezocision plus a ribose cross-linked collagen matrix (Ossix VOLUMAX) placed to support soft- and hard-tissue regeneration, while the control arm receives piezocision with a connective tissue graft (standard approach). Outcomes include changes in gingival thickness, alveolar bone volume, incidence of gingival recession, surgical morbidity, and treatment duration. The trial compares tissue regeneration and clinical outcomes between the two groups over the postoperative and orthodontic treatment period.

Who should consider this trial

Good fit: Ideal candidates are adults with a thin gingival phenotype (typically <1 mm), malocclusion involving the mandibular incisors, sufficient teeth and bone for orthodontic treatment, and no contraindications to oral surgery.

Not a fit: Patients with normal or thick gingival phenotype, insufficient tooth or bone support, or contraindications such as uncontrolled systemic disease or bisphosphonate therapy are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the combined approach could lead to thicker gums, increased alveolar bone volume, fewer recessions, and shorter or less morbid surgical procedures for affected patients.

How similar studies have performed: Collagen scaffolds have shown promise for soft- and hard-tissue regeneration in dental and implant contexts, but using Ossix VOLUMAX together with piezo-surgical decortication specifically for orthodontic acceleration is relatively novel and not widely tested.

Eligibility criteria

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.

Where this trial is running

Novosibirsk, Novosibirsk Oblast

• Dental Clinic "Dental-Service" - Department of Oral and Maxillofacial Surgery, 77 S. Vanzetti Street — Novosibirsk, Novosibirsk Oblast, Russia (RECRUITING)

Study contacts

• Study coordinator: Tatiana Gatilova Tatyana Andreevna

Conditions: Dental Crowding, Gingival Recession, Thin Phenotype, Corticotomy, Soft Tissue Augmantation, Bone Augmentation, Ossix Volume, Collagene Scaffold, Orthodontics, Piezocision