RMGI v Composite for Orthodontic Bonding
Launched by SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST · Aug 16, 2013
Trial Information
Current as of April 24, 2025
Completed
Keywords
ClinConnect Summary
Demineralization (dental decay) around fixed appliance components has been reported to occur in up to 95% of cases where brackets are bonded with composite resins. Although early lesions appear clinically as opaque white or brown areas, if mineral loss continues cavitation will occur. Following appliance removal, the lesions may regress or disappear but may still present an aesthetic problem more than 5 years after appliance removal. Fluoride is known to inhibit lesion development and to enhance remineralization following treatment. Resin-modified glass ionomer cements, which release and ab...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 11 years of age or older;
- • In good general health;
- • Brush his/her teeth at least once per day;
- • Have canine and incisor teeth fully erupted and of normal form on either side of upper/lower arch;
- • Require upper and/or lower pre-adjusted edgewise fixed appliance therapy;
- • Have given written informed consent;
- • Be willing and able to comply with the trial regime.
- Exclusion Criteria:
- • Undergoing orthognathic treatment;
- • Patients with a cleft of the lip or palate;
- • Patients with any heart condition or disease necessitating antibiotic cover;
- • Diabetes mellitus; epilepsy; physical or mental handicap;
- • Poor periodontal health, including the presence of supragingival calculus/subgingival calculus/periodontal pocketing greater than 3mm;
- • Gross or uncontrolled caries;
- • Labial demineralisation on a canine or incisor tooth;
- • Absent or peg-shaped lateral incisors;
- • Palatal canines and /or ectopic unerupted incisors.
Trial Officials
Philip E Benson, PhD
Principal Investigator
University of Sheffield
About Sheffield Teaching Hospitals Nhs Foundation Trust
Sheffield Teaching Hospitals NHS Foundation Trust is a leading healthcare institution in the UK, dedicated to delivering high-quality patient care, advancing medical research, and fostering education and training in the health sector. As a prominent sponsor of clinical trials, the Trust collaborates with various stakeholders to facilitate innovative research initiatives that aim to improve treatment outcomes and enhance patient safety. With a commitment to excellence, the organization leverages its extensive clinical expertise and resources to support the development of new therapies and interventions, ultimately contributing to the advancement of healthcare practices both locally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cork, , Ireland
Crewe, Cheshire, United Kingdom
Stevenage, Hertfordshire, United Kingdom
Sheffield, South Yorkshire, United Kingdom
Sheffield, South Yorkshire, United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials