Root CariesNCT03722758
36-Month Clinical Performance of Different Restorative Materials in the Treatment of Root Caries Lesions
A study testing Spectrum TPH3 and Riva LC in people with Root Caries, run by Hacettepe University.
Trial summary
This is a split-mouth, randomized clinical study that evaluating the 36-month performance of different restorative materials in the treatment of root caries lesions. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Root Caries
- What is being tested?
- Spectrum TPH3 and Riva LC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2016to 15 Nov 2019
- 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
- Root caries lesions (at least 1mm depth)
Who cannot join
- Complex medical history
- Poor dental hygiene/infrequent practise of oral hygiene habits
- Severe or chronic periodontitis
- Extreme carious activity
- Heavy bruxism
- Very deep (closer than 0.5 mm to the pulp) or superficial lesions (shallower than 1mm)
- Previously restored and abutment teeth for bridge or removable dental prostheses
About this study
Official title: Clinical Performance of a Micro-hybride Resin Based Composite in the Treatment of Cervical Caries Lesions: 36-month, Split-mouth, Randomized Clinical Trial
This is a split-mouth, randomized clinical study that evaluating the 36-month performance of different restorative materials in the treatment of root caries lesions. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18,24 and 36 months according to the USPHS criteria.
Read the detailed description
The aim of the study was to comparatively assess the 36-month clinical performance of a micro hybrid resin composite and resin-modified glass ionomer cement in root caries lesions.
Thirty-three patients with at least two root caries lesions participated in this study. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18, 24 and 36 months. The data were analyzed with Pearson's Chi-square, Cochran's Q, Friedman tests and Logistic Regression Analysis (p=0.05).
- Conditions
- Root Caries
- Being tested
- Spectrum TPH3, Riva LC
- Keywords
- micro hybrid resin composite, resin-modified glass ionomer, split-mouth randomized clinical trial
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectrum TPH3Device
Also called resin composite
tooth restoration with two different restorative materials
Riva LCDevice
Also called RMGİC
tooth restoration with two different restorative materials
| Study group | Role | What they receive |
|---|---|---|
| Spectrum TPH3, tooth restoration | Active comparator | Restoration with micro hybrid resin composite Receives: Device: Spectrum TPH3; Device: Riva LC |
| Riva LC, restorative material | Active comparator | Restoration with resin-modified glass ionomer cement Receives: Device: Spectrum TPH3; Device: Riva LC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal adaptation 0 for at least 90% restorations (marginal adaption score)
The primary factor for determining the clinical performance of a restorative material is the marginal adaption score. It represents the survival rates of the restorations after a period of time. According to ADA guidelines, a restorative material should show at least 90% survival rate after 18. The retention scored as 0 (restoration appears to adapt closely to the surface of the tooth with no crevice formation), 1 (an explorer caught lightly when run in both directions, and there was visible evidence of early crevice formation), 2 (an explorer got caught in both directions and penetrated a marginal crevice), 3 (the crevice had sufficient depth to expose the dentin, required replacement) or 4 (The restoration was fractured or lost).
Clinical evaluation is performed to examine if the restorations are in place or fallen.
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 posted29 Oct 2018
- Study start15 Jul 2016
- Primary completion15 Jul 2018
- Study completion15 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root CariesStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uzay Koc, Hacettepe University
- Investigators
- Uzay Koc-Vural, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722758
- Sponsor's protocol ID
- 2016/03-23 (KA-16003)
- Status last verified
- Jul 2019
- First submitted
- 24 Oct 2018
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of a Micro-hybride Resin Based Composite in the Treatment of Cervical Caries Lesions: 36-month, Split-mouth, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03722758
- Acronym / sponsor ID
- 2016/03-23 (KA-16003)
- Conditions
- Root Caries
- Keywords
- micro hybrid resin composite, resin-modified glass ionomer, split-mouth randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 15 Nov 2019 (estimated)
- First posted
- 29 Oct 2018 (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.
This is a split-mouth, randomized clinical study that evaluating the 36-month performance of different restorative materials in the treatment of root caries lesions. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18,24 and 36 months according to the USPHS criteria.
Detailed description
The aim of the study was to comparatively assess the 36-month clinical performance of a micro hybrid resin composite and resin-modified glass ionomer cement in root caries lesions.
Thirty-three patients with at least two root caries lesions participated in this study. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18, 24 and 36 months. The data were analyzed with Pearson's Chi-square, Cochran's Q, Friedman tests and Logistic Regression Analysis (p=0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spectrum TPH3, tooth restoration | Active comparator | Device: Spectrum TPH3, Device: Riva LCRestoration with micro hybrid resin composite |
| Riva LC, restorative material | Active comparator | Device: Spectrum TPH3, Device: Riva LCRestoration with resin-modified glass ionomer cement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Root caries lesions (at least 1mm depth)
Key exclusion criteria (7 listed)
- Complex medical history
- Poor dental hygiene/infrequent practise of oral hygiene habits
- 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 |
|---|---|---|
| Spectrum TPH3Also: resin compositetooth restoration with two different restorative materials | Device | Riva LC, restorative material, Spectrum TPH3, tooth restoration |
| Riva LCAlso: RMGİCtooth restoration with two different restorative materials | Device | Riva LC, restorative material, Spectrum TPH3, tooth restoration |
Primary outcome
Marginal adaptation 0 for at least 90% restorations (marginal adaption score)
Time frame: 24 months
The primary factor for determining the clinical performance of a restorative material is the marginal adaption score. It represents the survival rates of the restorations after a period of time. According to ADA guidelines, a restorative material should show at least 90% survival rate after 18. The retention scored as 0 (restoration appears to adapt closely to the surface of the tooth with no crevice formation), 1 (an explorer caught lightly when run in both directions, and there was visible evidence of early crevice formation), 2 (an explorer got caught in both directions and penetrated a marginal crevice), 3 (the crevice had sufficient depth to expose the dentin, required replacement) or 4 (The restoration was fractured or lost). Clinical evaluation is performed to examine if the restorations are in place or fallen.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
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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.
Uzay Koc-Vural principal investigator
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing Spectrum TPH3 and Riva LC in people with 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 15 Jul 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?
Marginal adaptation 0 for at least 90% restorations (marginal adaption score) (time frame: 24 months). 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 15 Jul 2019.