A new clinical trial aims to assess the effects of two major maxillary expansion methods—Mini-Screw Assisted Rapid Palatal Expansion (MARPE) and Surgically Assisted Rapid Maxillary Expansion (SARME)—on nasomaxillary structures. Sponsored by Merve Kulaksız, the study is currently recruiting participants.
What changed?
The trial introduces an evaluation of MARPE and SARME, targeting conditions such as maxillary expansion and transverse deficiency. Both methods aim to address these dental conditions effectively while impacting the nasomaxillary region differently. These methods are currently under systematic evaluation to understand their comparative safety, efficacy, and overall impact on patient outcomes. Recruitment is already underway as of January 10, 2026.
About the study
Interventions and conditions
The trial focuses on addressing maxillary transverse deficiency—a condition often associated with dental crowding, crossbite, and compromised airway function. The primary interventions include MARPE and SARME:
- MARPE: A minimally invasive device-based technique that expands the maxillary region using mini-screws to anchor the palatal expander, targeting both dental and skeletal components.
- SARME: A surgical procedure combined with orthodontic treatment designed to increase maxillary width. It involves cutting the maxilla mechanically before expanding it.
This study investigates the structural and functional effects of these methods on nasomaxillary anatomy, considering specific clinical parameters.
Sponsorship and oversight
The research is spearheaded by Merve Kulaksız, reflecting clinical and regulatory interest in advancing maxillary expansion solutions. The updated ClinicalTrials.gov listing provides transparency about interventions, sponsor integrity, and recruitment criteria.
Who should take note?
This trial primarily interests clinical, regulatory, and quality assurance teams:
- Regulatory professionals: To monitor clinical outcomes tied to SARME and MARPE devices under MDR (Medical Device Regulation) technical documentation requirements, particularly regarding intended purpose, safety, and performance.
- Orthodontists and maxillofacial surgeons: To gain insights into comparative efficacy of MARPE and SARME, guiding evidence-based decisions in practice.
- Medical device developers: To evaluate innovation opportunities, design outcomes, and competitive advantages in maxillary expansion devices.
Each stakeholder can use outcomes from this study to align strategies with clinical evidence and patient-centric safety measures.
Frequently Asked Questions
- What does MARPE stand for?
MARPE stands for Mini-Screw Assisted Rapid Palatal Expansion, a non-surgical method to correct transverse deficiencies by targeting skeletal expansion. - What are the main differences between MARPE and SARME?
MARPE relies on mini-screws for anchorage, avoiding surgical cuts, while SARME involves surgical assistance for bone expansion, typically reserved for severe cases. - What are the eligibility criteria to join the study?
Details about recruitment and criteria can be found at the official trial page on ClinicalTrials.gov.
Conclusion
This study will provide valuable data on two contrasting approaches, MARPE and SARME, for maxillary expansion. Key clinical and regulatory insights are expected to emerge, offering better guidance for both healthcare providers and device manufacturers. Stakeholders should monitor upcoming results to adapt to the latest evidence-based practices.
Disclaimer
This article is intended for informational purposes only and should not be considered legal or regulatory advice. Always refer to official sources for clinical and regulatory decisions.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07326345?term=medical+device