The Effect of Different Lining Strategies on Amalgam Restorations
1 other identifier
interventional
640
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Apr 2012
Longer than P75 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 21, 2015
CompletedFirst Posted
Study publicly available on registry
May 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 6, 2015
May 1, 2015
3.7 years
April 21, 2015
May 5, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Post-operative sensitivity
pain following placement reported by patient using a visual analog scale
28 days
Secondary Outcomes (2)
Condition of test teeth
24 months
Condition of restorations
24 months
Study Arms (4)
No lining
PLACEBO COMPARATORNo lining material placed under amalgam dental restoration
Calcium hydroxide cement
ACTIVE COMPARATORPlacement of calcium hydroxide cement under amalgam dental restorations
Bonding agent
ACTIVE COMPARATORPlacement of Resin bonding agent under amalgam dental restorations
RMGI cement
ACTIVE COMPARATORPlacement of rmgi lining under amalgam dental restorations
Interventions
placement of lining material under amalgam dental restorations
placement of lining material under amalgam dental restorations
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Replacement restorations
- Psychiatric conditions or medication which may affect pain perception.
- Cavities limited to the outer â…“ 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Birminghamlead
- Shirley Glasstone Hughes Trust Fundcollaborator
Study Sites (1)
University of Birmingham, School of Dentistry
Birmingham, West Midlands, B4 6NN, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dominic A Stewardson, PhD
University of Birmingham, School of Dentistry
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer in Restorative Dentistry
Study Record Dates
First Submitted
April 21, 2015
First Posted
May 6, 2015
Study Start
April 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2017
Last Updated
May 6, 2015
Record last verified: 2015-05