Dental CariesPhase 4NCT01567514
Postoperative Pulpal Complications in Posterior Resin Composite Restorations Without Glass-ionomer Cement Lining
A Phase 4 study testing Glass ionomer cement lining in people with Dental Caries, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to observe the effects of glass-ionomer cement (GIC) lining on risk of pulpal complications in deep occlusal cavities with resin-based restorations. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Glass ionomer cement lining
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2008to Mar 2011
- Phase
- Phase 4
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Deep dental caries on occlusal surfaces of molar teeth
Who cannot join
- Shallow and moderate-depth caries
- Caries exposed pulp
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 2-year Clinical Study on Postoperative Pulpal Complications Arising From the Absence of a Glass-ionomer Lining in Deep Occlusal Resin Composite Restorations
The purpose of this study is to observe the effects of glass-ionomer cement (GIC) lining on risk of pulpal complications in deep occlusal cavities with resin-based restorations.
Read the detailed description
Fifty three patients aged 18-30 years who had one or two deep occlusal carious lesions (≥ 3 mm in depth) in molars were recruited. Dental caries was removed and the prepared cavity was restored with resin composite using one of two restorative procedures: (1) without GIC lining; (2) with (resin-modified) GIC lining. Restored teeth were evaluated for any pulpal complications (subjective symptoms, objective signs or loss of tooth vitality) at one month (baseline), one year and two years after restoration.
- Conditions
- Dental Caries
- Being tested
- Glass ionomer cement lining
- Keywords
- Deep occlusal caries restored with resin composite, on Pit and Fissure Surface Penetrating Into Dentin
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glass ionomer cement liningProcedure or surgery
Also called Vitrebond (3M ESPE, St. Paul, MN, USA)
Resin-modified glass ionomer lining
| Study group | Role | What they receive |
|---|---|---|
| Glass-ionomer cement lining | Active comparator | Presence of glass-ionomer cement lining in posterior resin composite restorations. Receives: Procedure: Glass ionomer cement lining |
| No glass-ionomer cement lining | No intervention | Absence of glass-ionomer cement lining in posterior resin composite restorations Receives: Procedure: Glass ionomer cement lining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulpal complications
Signs and symptoms (subjective/objective) of pulpal \& periapical diseases. Response to electrical pulp testing.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMar 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Melbourne
- Responsible party
- Sponsor
- Investigators
- Emeritus Prof. Harold Messer, Ph.D., Study director, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567514
- Sponsor's protocol ID
- MU-IRB 2008/269.3110
- Status last verified
- Mar 2012
- First submitted
- 28 Mar 2012
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-year Clinical Study on Postoperative Pulpal Complications Arising From the Absence of a Glass-ionomer Lining in Deep Occlusal Resin Composite Restorations
- ClinicalTrials.gov ID
- NCT01567514
- Acronym / sponsor ID
- MU-IRB 2008/269.3110
- Conditions
- Dental Caries
- Keywords
- Deep occlusal caries restored with resin composite, on Pit and Fissure Surface Penetrating Into Dentin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- University of Melbourne
- Study start
- Mar 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 30 Mar 2012 (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 purpose of this study is to observe the effects of glass-ionomer cement (GIC) lining on risk of pulpal complications in deep occlusal cavities with resin-based restorations.
Detailed description
Fifty three patients aged 18-30 years who had one or two deep occlusal carious lesions (≥ 3 mm in depth) in molars were recruited. Dental caries was removed and the prepared cavity was restored with resin composite using one of two restorative procedures: (1) without GIC lining; (2) with (resin-modified) GIC lining. Restored teeth were evaluated for any pulpal complications (subjective symptoms, objective signs or loss of tooth vitality) at one month (baseline), one year and two years after restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glass-ionomer cement lining | Active comparator | Procedure: Glass ionomer cement liningPresence of glass-ionomer cement lining in posterior resin composite restorations. |
| No glass-ionomer cement lining | No intervention | Procedure: Glass ionomer cement liningAbsence of glass-ionomer cement lining in posterior resin composite restorations |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Deep dental caries on occlusal surfaces of molar teeth
Key exclusion criteria (2 listed)
- Shallow and moderate-depth caries
- Caries exposed pulp
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 |
|---|---|---|
| Glass ionomer cement liningAlso: Vitrebond (3M ESPE, St. Paul, MN, USA)Resin-modified glass ionomer lining | Procedure or surgery | Glass-ionomer cement lining, No glass-ionomer cement lining |
Primary outcome
Postoperative pulpal complications
Time frame: 2 years
Signs and symptoms (subjective/objective) of pulpal \& periapical diseases. Response to electrical pulp testing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
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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.
Emeritus Prof. Harold Messer, Ph.D. study director
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glass ionomer cement lining in people with Dental Caries, run by Mahidol University at 1 site in Thailand.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 30 Mar 2012. 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 Thailand. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pulpal complications (time frame: 2 years). 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 30 Mar 2012; AzTrials last refreshed its copy on 7 Nov 2026.