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

Launched by NMSI DENTMASTER · Jul 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to improve orthodontic treatment (braces and teeth alignment) by using a special material called a collagen scaffold (Ossix VOLUMAX) along with a gentle bone procedure called piezo-surgical decortication. Collagen is a natural substance in our bones that helps with healing and tissue growth. The goal is to see if this combination can help patients with crowded teeth, thin gums, or gum recession heal faster and get better results from their orthodontic treatment.

People who might join the study are those with thin gums (less than 1 mm thick) and specific types of dental crowding or misaligned lower front teeth. They should have enough healthy teeth and bone to safely undergo orthodontic treatment and surgery. Participants need to be in good overall dental health, not currently have active gum disease, and must not have had orthodontic work in the last six months. Non-smokers or light smokers are preferred to ensure better healing. If you join, you’ll receive the treatment and attend regular follow-up visits to monitor progress. The study is looking for adults and teens who meet these requirements and are willing to commit to the entire treatment and follow-up schedule.

Gender

ALL

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.