The Effect of Different Lining Strategies on Amalgam Restorations

Dental Caries Clinical Trial

Official title:

The Effect of Different Lining Strategies on Amalgam Restorations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02435459
• Other study ID #: RG_12-054
• Status: Recruiting
• Phase: N/A
• First received: April 21, 2015
• Last updated: May 5, 2015
• Start date: April 2012
• Est. completion date: December 2017

Study information

• Verified date: May 2015
• Source: University of Birmingham
• Contact: Dominic A Stewardson, PhD
• Phone: 0121 4665489
• Email: d.a.stewardson[@]bham.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ? 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

Study Design

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

Related Conditions & MeSH terms

• Dental Caries
• Pain, Postoperative
• Post-operative Pain

Intervention

Procedure:
• No lining
No lining material placed under amalgam dental restorations
• Calcium Hydroxide cement
placement of lining material under amalgam dental restorations
• RMGI cement
placement of lining material under amalgam dental restorations
• Resin Bonding Agent
placement of lining material under amalgam dental restorations

Locations

Country	Name	City	State
United Kingdom	University of Birmingham, School of Dentistry	Birmingham	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
University of Birmingham	Shirley Glasstone Hughes Trust Fund

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative sensitivity	pain following placement reported by patient using a visual analog scale	28 days	No
Secondary	Condition of test teeth	Pulp vitality assessed using an electronic pulp tester	24 months	No
Secondary	Condition of restorations	condition of restorations assessed visually using United States Public Health Service criteria	24 months	No