Teeth; LesionNCT03802539
5-year Clinical Evaluation of Cavity Lining on the Restoration
A study testing Glass Liner in people with Teeth; Lesion and Dental Root Caries, run by Hacettepe University.
Trial summary
The purpose of this double-blind, randomized trial is to compare the clinical performance of a composite restorations in root surface carious lesions with or without resin modified glass ionomer lining. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Teeth; Lesion, Dental Root Caries
- What is being tested?
- Glass Liner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jan 2020
- 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 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-hospitalized, healthy patients that were seeking dental treatment for caries lesions on the root surface
Who cannot join
- Patients who were under the age of 18 years
- Complex medical history
- Severe or chronic periodontitis
- Extreme carious activity
- Heavy bruxism
- Very deep or superficial carious lesions
- Previously restored and abutment teeth
About this study
Official title: 5-year Clinical Evaluation of Cavity Lining on the Restoration of Root Surface Caries Lesions: A Controlled Randomized Clinical Trial
The purpose of this double-blind, randomized trial is to compare the clinical performance of a composite restorations in root surface carious lesions with or without resin modified glass ionomer lining.
Read the detailed description
Thirty-nine patients with at least one pair of equivalent root caries lesions and a mean age of 39.6 years (range 18-65 years; median 39 years) were enrolled in this study. After caries removal, the depth, length, and width of the cavity were measured. Lesions in the same patient was randomly divided into two groups, and the dentin surfaces were either lined with resin-modified glass ionomer liner (Glass liner II, Willmann \& Pein GmbH Dental, Barmstedt, Germany) or not. All cavities were restored with nanohybrid composite resin (Clearfil Majesty Esthetic, Kuraray, Tokyo, Japan). A total of 100 restorations (50 lined, 50 unlined) were placed according to manufacturer's instructions. The restorations will be evaluated at baseline and at 6, 12, 24, 36, 48 months and 5-year after placement using the modified Haveman Criteria for marginal adaptation, anatomic form, marginal staining, anatomic form, caries in adjacent tooth structure, caries at the cavosurface margin and sensitivity. Statistical analysis will be conducted using the Chi- Square, Fisher's Exact, Mann Whitney-U and Cochran Q tests at a significance level of 5% (P < 0.05).
- Conditions
- Teeth; Lesion, Dental Root Caries
- Being tested
- Glass Liner
- Keywords
- Root caries, Cavity lining, Composite resin restorations, Self-etch adhesive
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glass LinerDevice
restoration of root caries according to two different protocols
| Study group | Role | What they receive |
|---|---|---|
| Glass Liner | Experimental | Tooth restoration with a glass ionomer liner material under a nanohybrid composite resin Receives: Device: Glass Liner |
| No liner | No intervention | Tooth restoration without a glass ionomer liner material under a nanohybrid composite resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Outcome
1.Retention Alpha for at least 90% of the restorations The primary factor for determining the clinical performance of a restorative material is the retention rate. It represents the survival rates of the restorations after a period of time. According to ADA (American Dental Association) guidelines, a restorative material should show at leat 90% alpha retention rate after 18 months to be considered as clinically acceptable. The retention is assessed as alpha (retentive restoration) or charlie (failed restoration). Clinical evaluation is performed to examine if the restoration is in place or has fallen.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start1 Jan 2014
- Primary completion1 Jul 2016
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Teeth; LesionStudies of the same condition, open and under way.
- More trials run by Hacettepe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uzay Koc, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802539
- Sponsor's protocol ID
- HEK 11/54-8
- Status last verified
- Jan 2019
- First submitted
- 6 Jan 2019
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koc Vural U, Gokalp S, Kiremitci A. Effect of cavity lining on the restoration of root surface carious lesions: a split-mouth, 5-year randomized controlled clinical trial. Clin Oral Investig. 2020 Feb;24(2):979-989. doi: 10.1007/s00784-019-03001-z. Epub 2019 Jul 4.
PubMed 31273529
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5-year Clinical Evaluation of Cavity Lining on the Restoration of Root Surface Caries Lesions: A Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03802539
- Acronym / sponsor ID
- HEK 11/54-8
- Conditions
- Teeth; Lesion, Dental Root Caries
- Keywords
- Root caries, Cavity lining, Composite resin restorations, Self-etch adhesive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 14 Jan 2019 (actual)
- 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 double-blind, randomized trial is to compare the clinical performance of a composite restorations in root surface carious lesions with or without resin modified glass ionomer lining.
Detailed description
Thirty-nine patients with at least one pair of equivalent root caries lesions and a mean age of 39.6 years (range 18-65 years; median 39 years) were enrolled in this study. After caries removal, the depth, length, and width of the cavity were measured. Lesions in the same patient was randomly divided into two groups, and the dentin surfaces were either lined with resin-modified glass ionomer liner (Glass liner II, Willmann \& Pein GmbH Dental, Barmstedt, Germany) or not. All cavities were restored with nanohybrid composite resin (Clearfil Majesty Esthetic, Kuraray, Tokyo, Japan). A total of 100 restorations (50 lined, 50 unlined) were placed according to manufacturer's instructions. The restorations will be evaluated at baseline and at 6, 12, 24, 36, 48 months and 5-year after placement using the modified Haveman Criteria for marginal adaptation, anatomic form, marginal staining, anatomic form, caries in adjacent tooth structure, caries at the cavosurface margin and sensitivity. Statistical analysis will be conducted using the Chi- Square, Fisher's Exact, Mann Whitney-U and Cochran Q tests at a significance level of 5% (P < 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glass Liner | Experimental | Device: Glass LinerTooth restoration with a glass ionomer liner material under a nanohybrid composite resin |
| No liner | No intervention | –Tooth restoration without a glass ionomer liner material under a nanohybrid composite resin |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-hospitalized, healthy patients that were seeking dental treatment for caries lesions on the root surface
Key exclusion criteria (7 listed)
- Patients who were under the age of 18 years
- Complex medical history
- Severe or chronic periodontitis
- Extreme carious activity
- Heavy bruxism
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 Linerrestoration of root caries according to two different protocols | Device | Glass Liner |
Primary outcome
Retention Outcome
Time frame: 5 years
1.Retention Alpha for at least 90% of the restorations The primary factor for determining the clinical performance of a restorative material is the retention rate. It represents the survival rates of the restorations after a period of time. According to ADA (American Dental Association) guidelines, a restorative material should show at leat 90% alpha retention rate after 18 months to be considered as clinically acceptable. The retention is assessed as alpha (retentive restoration) or charlie (failed restoration). Clinical evaluation is performed to examine if the restoration is in place or has fallen.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Derived from this study: PubMed 31273529Koc Vural U, Gokalp S, Kiremitci A. Effect of cavity lining on the restoration of root surface carious lesions: a split-mouth, 5-year randomized controlled clinical trial. Clin Oral Investig. 2020 Feb;24(2):979-989. doi: 10.1007/s00784-019-03001-z. Epub 2019 Jul 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Glass Liner in people with Teeth; Lesion and Dental Root Caries, run by Hacettepe University.
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 7 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 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
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?
Retention Outcome (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03802539, which also lists 1 linked publication.
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 14 Jan 2019.