The Effect of Different Lining Strategies on Amalgam Rest... | NCT02435459

Studies
The Effect of Different Lining Strategies on Amalgam Restorations

NCT02435459

Sponsor

University of Birmingham

Status

Unknown status

Last Update Posted

May 6, 2015Estimated

Enrollment

640Estimated

Phase

Not Applicable

Conditions

Post-operative Pain
Dental Caries

Interventions

No lining
Calcium Hydroxide cement
RMGI cement
Resin Bonding Agent

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Apr 21, 2015

First Submission Date that Met QC Criteria

May 5, 2015

First Posted Date

May 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2015

Last Update Posted Date

May 6, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dominic Stewardson, Senior Lecturer in Restorative Dentistry, University of BirminghamPrincipal Investigator

Lead Sponsor

University of BirminghamOTHER

Collaborators

Name	Class
Shirley Glasstone Hughes Trust Fund	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

640Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No lining	Placebo Comparator	No lining material placed under amalgam dental restoration	Procedure: No lining
Calcium hydroxide cement	Active Comparator	Placement of calcium hydroxide cement under amalgam dental restorations	Procedure: Calcium Hydroxide cement
Bonding agent	Active Comparator	Placement of Resin bonding agent under amalgam dental restorations	Procedure: Resin Bonding Agent
RMGI cement	Active Comparator	Placement of rmgi lining under amalgam dental restorations	Procedure: RMGI cement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No lining	Procedure	No lining material placed under amalgam dental restorations	No lining

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dominic A Stewardson, PhD	Contact	0121 4665489		d.a.stewardson@bham.ac.uk
Kirsty B Hill, PhD	Contact	0121 4665488		K.B.Hill@bham.ac.uk

Overall Officials

Name	Affiliation	Role
Dominic A Stewardson, PhD	University of Birmingham, School of Dentistry	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Birmingham, School of Dentistry	Recruiting	Birmingham	West Midlands	B4 6NN	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D003731	Dental Caries

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C031028	Cal-Mer cement
C069300	Tripton resin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided