The Effect of Different Lining Strategies on Amalgam Restorations
NCT ID: NCT02435459
Last Updated: 2015-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
640 participants
INTERVENTIONAL
2012-04-30
2017-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No lining
No lining material placed under amalgam dental restoration
No lining
No lining material placed under amalgam dental restorations
Calcium hydroxide cement
Placement of calcium hydroxide cement under amalgam dental restorations
Calcium Hydroxide cement
placement of lining material under amalgam dental restorations
Bonding agent
Placement of Resin bonding agent under amalgam dental restorations
Resin Bonding Agent
placement of lining material under amalgam dental restorations
RMGI cement
Placement of rmgi lining under amalgam dental restorations
RMGI cement
placement of lining material under amalgam dental restorations
Interventions
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No lining
No lining material placed under amalgam dental restorations
Calcium Hydroxide cement
placement of lining material under amalgam dental restorations
RMGI cement
placement of lining material under amalgam dental restorations
Resin Bonding Agent
placement of lining material under amalgam dental restorations
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Shirley Glasstone Hughes Trust Fund
UNKNOWN
University of Birmingham
OTHER
Responsible Party
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Dominic Stewardson
Senior Lecturer in Restorative Dentistry
Principal Investigators
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Dominic A Stewardson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Birmingham, School of Dentistry
Locations
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University of Birmingham, School of Dentistry
Birmingham, West Midlands, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RG_12-054
Identifier Type: -
Identifier Source: org_study_id
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