The Effect of Different Lining Strategies on Amalgam Restorations

Not Applicable

• Conditions: Post-operative Pain; Dental Caries
• Interventions: Procedure: Calcium Hydroxide cement; Procedure: No lining; Procedure: RMGI cement; Procedure: Resin Bonding Agent

• Registration Number: NCT02435459
• Lead Sponsor: University of Birmingham

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).

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2015-04-21
• Status Verified: 2015-05
• Study First Submitted QC: 2015-05-05
• Last Update Submitted: 2015-05-05
• Study First Posted: 2015-05-06
• Last Update Posted: 2015-05-06
• Primary Completion: 2015-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 640

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium hydroxide cement	Calcium Hydroxide cement	Placement of calcium hydroxide cement under amalgam dental restorations
No lining	No lining	No lining material placed under amalgam dental restoration
RMGI cement	RMGI cement	Placement of rmgi lining under amalgam dental restorations
Bonding agent	Resin Bonding Agent	Placement of Resin bonding agent under amalgam dental restorations

Primary Outcome Measures

Name	Time	Method
Post-operative sensitivity	28 days	pain following placement reported by patient using a visual analog scale

Secondary Outcome Measures

Name	Time	Method
Condition of test teeth	24 months	Pulp vitality assessed using an electronic pulp tester
Condition of restorations	24 months	condition of restorations assessed visually using United States Public Health Service criteria

Trial Locations

Locations (1)

University of Birmingham, School of Dentistry; 🇬🇧 Birmingham, West Midlands, United Kingdom