The Effect of Different Lining Strategies on Amalgam Restorations

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02435459
Study type	Interventional
Source	University of Birmingham
Contact	Dominic A Stewardson, PhD
Phone	0121 4665489
Email	d.a.stewardson@bham.ac.uk
Status	Recruiting
Phase	N/A
Start date	April 2012
Completion date	December 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04127929` - Investigation of Glass Carbomer Performance	N/A
Completed	`NCT04769882` - Er:YAG Laser Effects on Microbial Population in Conservative Dentistry	N/A
Completed	`NCT04971317` - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages	N/A
Active, not recruiting	`NCT04475679` - Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy	N/A
Completed	`NCT05438381` - Comparison of Clinical and Radiographic Outcomes of SMART Technique vs ART in Primary Molars	N/A
Not yet recruiting	`NCT03037814` - Clinical Performance of Restorative Materials in Primary Teeth	N/A
Active, not recruiting	`NCT05202665` - Resin Infiltration and Fluoride Varnish Lesion Arresting Efficacy on Non-cavitated Proximal Lesion	N/A
Terminated	`NCT01147835` - Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers	N/A
Not yet recruiting	`NCT04033263` - Maintaining Oral Health With Bio-products	N/A
Enrolling by invitation	`NCT04438252` - Evaluation of Reliability of CarieScan PRO Compared With Digital Radiograph and ICDAS-II in Detection of Carious Lesions	N/A
Not yet recruiting	`NCT03609034` - Knowledge, Attitude and Practice of a Group of Egyptian Dental Interns Toward Caries Risk Assessment
Completed	`NCT02912000` - TEACH: Technology Evaluation to Address Child Health	N/A
Completed	`NCT02473107` - Impact of Detecting Initial and Active Caries Lesions in Primary Teeth	N/A
Active, not recruiting	`NCT02537184` - Impact of Two Recall Intervals on Dental Caries Incidence and Other Outcomes of Preschool Children	N/A
Completed	`NCT01950546` - Nanosilver Fluoride to Prevent Dental Biofilms Growth	Phase 1
Recruiting	`NCT02734420` - Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial	Phase 1
Completed	`NCT02020681` - Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions	N/A
Completed	`NCT02234609` - Effectiveness of Modified Class IV Atraumatic Restorative Treatment	N/A
Completed	`NCT02426619` - Arresting Active Dental Caries in Preschool Children by Topical Fluorides	Phase 2/Phase 3
Withdrawn	`NCT01224002` - A Comparative Feasibility Study to Assess the Prevalence and Severity of Dental Caries in Incarcerated People Who Abuse Methamphetamine	N/A