The aim of this research is to compare the clinical outcome of amalgam restorations placed in conjunction with three different lining protocols, each of which represents a different therapeutic concept.
Patients attending one of eight, United Kingdom general dental practitioners for a new restoration in a posterior tooth will be recruited and informed consent obtained. Each dentist will place 20 amalgam restorations either unlined (control), or lined with calcium hydroxide cement, rmgi cement, or sealed with a resin bonding agent (total - 640). Pre-operative radiographs and pulp testing will be performed and measurement of cavity size to assess the remaining dental thickness. The pulp status and symptoms will be recorded at 6, 12, and 24 months. Post-operative sensitivity will be recorded by the patient at 1, 3, 7, 14 and 28 days using a visual analogue scale and diary. The dentists will be trained and calibrated to use United States Public Health Service criteria and the condition of the restoration will be assessed at 12 and 24 months. For each lining option, one product and one admixed amalgam will be provided for use by all the dentists. Training and instruction will be given on the application of the liners and on amalgam condensation to increase standardisation. The collected data will be assessed to identify any association between the outcome variables and the pre-treatment tooth condition or lining material used using logistic regression (α=0.05).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
640
No lining material placed under amalgam dental restorations
placement of lining material under amalgam dental restorations
placement of lining material under amalgam dental restorations
University of Birmingham, School of Dentistry
Birmingham, West Midlands, United Kingdom
RECRUITINGPost-operative sensitivity
pain following placement reported by patient using a visual analog scale
Time frame: 28 days
Condition of test teeth
Pulp vitality assessed using an electronic pulp tester
Time frame: 24 months
Condition of restorations
condition of restorations assessed visually using United States Public Health Service criteria
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
placement of lining material under amalgam dental restorations