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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorNMSI DENTMASTER

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax)

    Procedure/Surgery

    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.

  • control

    Procedure/Surgery

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Increase 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.

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

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