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Search / Trial NCT01925924

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

Dental Cements Orthodontic Adhesives Glass Ionomer Cement Tooth Demineralization

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.

Locations

Cork, , Ireland

Crewe, Cheshire, United Kingdom

Stevenage, Hertfordshire, United Kingdom

Sheffield, South Yorkshire, United Kingdom

Sheffield, South Yorkshire, United Kingdom

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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