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The Effect of Different Lining Strategies on Amalgam Restorations

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ClinicalTrials.gov Identifier: NCT02435459
Recruitment Status : Unknown
Verified May 2015 by Dominic Stewardson, University of Birmingham.
Recruitment status was:  Recruiting
First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Sponsor:
Collaborator:
Shirley Glasstone Hughes Trust Fund
Information provided by (Responsible Party):
Dominic Stewardson, 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.

Condition or disease Intervention/treatment Phase
Post-operative Pain Dental Caries Procedure: No lining Procedure: Calcium Hydroxide cement Procedure: RMGI cement Procedure: Resin Bonding Agent Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Different Lining Strategies on Amalgam Restorations
Study Start Date : April 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2017

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




Primary Outcome Measures :
  1. Post-operative sensitivity [ Time Frame: 28 days ]
    pain following placement reported by patient using a visual analog scale


Secondary Outcome Measures :
  1. Condition of test teeth [ Time Frame: 24 months ]
    Pulp vitality assessed using an electronic pulp tester

  2. Condition of restorations [ Time Frame: 24 months ]
    condition of restorations assessed visually using United States Public Health Service criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435459


Contacts
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Contact: Dominic A Stewardson, PhD 0121 4665489 d.a.stewardson@bham.ac.uk
Contact: Kirsty B Hill, PhD 0121 4665488 K.B.Hill@bham.ac.uk

Locations
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United Kingdom
University of Birmingham, School of Dentistry Recruiting
Birmingham, West Midlands, United Kingdom, B4 6NN
Contact: Dominic A Stewardson, PhD    0121 4665489    d.a.stewardson@bham.ac.uk   
Contact: Kirsty B Hill, PhD    0121 4665488    K.B.Hill@bham.ac.uk   
Sponsors and Collaborators
University of Birmingham
Shirley Glasstone Hughes Trust Fund
Investigators
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Principal Investigator: Dominic A Stewardson, PhD University of Birmingham, School of Dentistry
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Responsible Party: Dominic Stewardson, Senior Lecturer in Restorative Dentistry, University of Birmingham
ClinicalTrials.gov Identifier: NCT02435459    
Other Study ID Numbers: RG_12-054
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Dental Caries
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs