Dental Caries, Post-operative Pain
Conditions
Brief summary
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.
Detailed description
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).
Interventions
PROCEDURENo lining
No lining material placed under amalgam dental restorations
PROCEDURECalcium Hydroxide cement
placement of lining material under amalgam dental restorations
PROCEDURERMGI cement
placement of lining material under amalgam dental restorations
PROCEDUREResin Bonding Agent
placement of lining material under amalgam dental restorations
Sponsors
Shirley Glasstone Hughes Trust Fund
University of Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults over 18 years * Presence of one or more carious cavities extending beyond the outer 1/3 of the dentine * Able to give valid consent to participate in study * Willing to receive an amalgam restoration in a target tooth * Teeth free from pain * Teeth with vital pulps
Exclusion criteria
* Replacement restorations * Psychiatric conditions or medication which may affect pain perception. * Cavities limited to the outer ⅓ of dentine. * Teeth with existing symptoms or sensitivity * Patients under 18 years * Non-vital teeth * Allergy or idiosyncratic reaction to the study materials * Inability to return for review * Fractured or cracked teeth * Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative sensitivity | 28 days | pain following placement reported by patient using a visual analog scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Condition of restorations | 24 months | condition of restorations assessed visually using United States Public Health Service criteria |
| Condition of test teeth | 24 months | Pulp vitality assessed using an electronic pulp tester |
Countries
United Kingdom
Contacts
Primary ContactDominic A Stewardson, PhD
Backup ContactKirsty B Hill, PhD
Outcome results
None listed