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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: tagatilova@gmail.com
• Phone: 0079529399919

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.