Post-operative PainNCT02435459
The Effect of Different Lining Strategies on Amalgam Restorations
A study testing No lining, Calcium Hydroxide cement and RMGI cement in people with Post-operative Pain and Dental Caries, run by University of Birmingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain, Dental Caries
- What is being tested?
- No lining, Calcium Hydroxide cement and RMGI cement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 640 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Allergy or idiosyncratic reaction to the study materials
- Inability to return for review
- Fractured or cracked teeth
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Birmingham, School of Dentistry
Birmingham, West Midlands, B4 6NN
Dominic A Stewardson, PhD, 0121 4665489, d.a.stewardson@bham.ac.uk
Kirsty B Hill, PhD, 0121 4665488, K.B.Hill@bham.ac.uk
About this study
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.
Read the 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).
- Conditions
- Post-operative Pain, Dental Caries
- Being tested
- No lining, Calcium Hydroxide cement, RMGI cement, Resin Bonding Agent
- Medical subject headings
- Pain, Postoperative, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No liningProcedure or surgery
No lining material placed under amalgam dental restorations
Calcium Hydroxide cementProcedure or surgery
placement of lining material under amalgam dental restorations
RMGI cementProcedure or surgery
placement of lining material under amalgam dental restorations
Resin Bonding AgentProcedure or surgery
placement of lining material under amalgam dental restorations
| Study group | Role | What they receive |
|---|---|---|
| No lining | Placebo comparator | No lining material placed under amalgam dental restoration Receives: Procedure: No lining |
| Calcium hydroxide cement | Active comparator | Placement of calcium hydroxide cement under amalgam dental restorations Receives: Procedure: Calcium Hydroxide cement |
| Bonding agent | Active comparator | Placement of Resin bonding agent under amalgam dental restorations Receives: Procedure: Resin Bonding Agent |
| RMGI cement | Active comparator | Placement of rmgi lining under amalgam dental restorations Receives: Procedure: RMGI cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative sensitivity
pain following placement reported by patient using a visual analog scale
Measured: 28 days
Secondary outcomes (2)
Condition of test teeth
Pulp vitality assessed using an electronic pulp tester
Measured: 24 months
Condition of restorations
condition of restorations assessed visually using United States Public Health Service criteria
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startApr 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Shirley Glasstone Hughes Trust Fund
- Responsible party
- Principal investigator, Dominic Stewardson, University of Birmingham
- Investigators
- Dominic A Stewardson, PhD, Principal investigator, University of Birmingham, School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435459
- Sponsor's protocol ID
- RG_12-054
- Status last verified
- May 2015
- First submitted
- 21 Apr 2015
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Lining Strategies on Amalgam Restorations
- ClinicalTrials.gov ID
- NCT02435459
- Acronym / sponsor ID
- RG_12-054
- Conditions
- Post-operative Pain, Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Shirley Glasstone Hughes Trust Fund
- Study start
- Apr 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No lining | Placebo comparator | Procedure: No liningNo lining material placed under amalgam dental restoration |
| Calcium hydroxide cement | Active comparator | Procedure: Calcium Hydroxide cementPlacement of calcium hydroxide cement under amalgam dental restorations |
| Bonding agent | Active comparator | Procedure: Resin Bonding AgentPlacement of Resin bonding agent under amalgam dental restorations |
| RMGI cement | Active comparator | Procedure: RMGI cementPlacement of rmgi lining under amalgam dental restorations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No liningNo lining material placed under amalgam dental restorations | Procedure or surgery | No lining |
| Calcium Hydroxide cementplacement of lining material under amalgam dental restorations | Procedure or surgery | Calcium hydroxide cement |
| RMGI cementplacement of lining material under amalgam dental restorations | Procedure or surgery | RMGI cement |
| Resin Bonding Agentplacement of lining material under amalgam dental restorations | Procedure or surgery | Bonding agent |
Primary outcome
Post-operative sensitivity
Time frame: 28 days
pain following placement reported by patient using a visual analog scale
2 secondary outcomes
Condition of test teeth
Time frame: 24 months
Condition of restorations
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominic A Stewardson, PhD principal investigator
University of Birmingham, School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No lining, Calcium Hydroxide cement and RMGI cement in people with Post-operative Pain and Dental Caries, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominic A Stewardson, PhD (0121 4665489, d.a.stewardson@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative sensitivity (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.