The Effect of Different Lining Strategies on Amalgam Restorations

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.

Study Overview

• Status: Unknown
• Conditions: Dental Caries; Post-operative Pain
• Intervention / Treatment: Procedure: No lining; Procedure: Calcium Hydroxide cement; Procedure: Resin Bonding Agent; Procedure: RMGI cement

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 Type: Interventional
• Enrollment (Anticipated): 640
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominic A Stewardson, PhD; Phone Number: 0121 4665489; Email: d.a.stewardson@bham.ac.uk
• Study Contact Backup: Name: Kirsty B Hill, PhD; Phone Number: 0121 4665488; Email: K.B.Hill@bham.ac.uk

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B4 6NN
      • Recruiting
      • University of Birmingham, School of dentistry
      • Contact: Dominic A Stewardson, PhD; Phone Number: 0121 4665489; Email: d.a.stewardson@bham.ac.uk
      • Contact: Kirsty B Hill, PhD; Phone Number: 0121 4665488; Email: K.B.Hill@bham.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: No lining; No lining material placed under amalgam dental restoration	Procedure: No lining; No lining material placed under amalgam dental restorations
Active Comparator: Calcium hydroxide cement; Placement of calcium hydroxide cement under amalgam dental restorations	Procedure: Calcium Hydroxide cement; placement of lining material under amalgam dental restorations
Active Comparator: Bonding agent; Placement of Resin bonding agent under amalgam dental restorations	Procedure: Resin Bonding Agent; placement of lining material under amalgam dental restorations
Active Comparator: RMGI cement; Placement of rmgi lining under amalgam dental restorations	Procedure: RMGI cement; placement of lining material under amalgam dental restorations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative sensitivity	pain following placement reported by patient using a visual analog scale	28 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Birmingham
• Collaborators: Shirley Glasstone Hughes Trust Fund
• Investigators: Principal Investigator: Dominic A Stewardson, PhD, University of Birmingham, School of dentistry

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: April 21, 2015
• First Submitted That Met QC Criteria: May 5, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Estimate): May 6, 2015
• Last Update Submitted That Met QC Criteria: May 5, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Pain, Postoperative; Dental Caries; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: RG_12-054