The Effect of Different Lining Strategies on Amalgam Restorations

Sponsor

University of Birmingham (Other)

Overall Status

Unknown status

CT.gov ID

NCT02435459

Collaborator

Shirley Glasstone Hughes Trust Fund (Other)

640

Enrollment

Location

Arms

Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Post-operative sensitivity [28 days]
pain following placement reported by patient using a visual analog scale

Secondary Outcome Measures

Condition of test teeth [24 months]
Pulp vitality assessed using an electronic pulp tester
Condition of restorations [24 months]
condition of restorations assessed visually using United States Public Health Service criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Birmingham, School of Dentistry	Birmingham	West Midlands	United Kingdom	B4 6NN

Sponsors and Collaborators

University of Birmingham
Shirley Glasstone Hughes Trust Fund

Investigators

Principal Investigator: Dominic A Stewardson, PhD, University of Birmingham, School of Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Last Update Posted:

May 6, 2015

Last Verified:

May 1, 2015

Additional relevant MeSH terms:

Dental Caries

Pain, Postoperative

Calcium

Study Results

No Results Posted as of May 6, 2015