Non-carious Cervical LesionNCCLNCT05573243
Clinical Evaluation of Composite Restorations Using Two-steps Universal Adhesive in Non-carious Cervical Lesion (NCCL)
A study testing bonding strategies in people with Non-carious Cervical Lesion, run by Mahidol University at 1 site in Thailand.
Trial summary
The goal of this clinical study is to compare the clinical performance of a new 2-steps universal adhesive in patients with non-carious cervical lesions. The main question it aims to answer is: Is there any difference in clinical performance of a new 2-steps universal adhesives bonded with different etching… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-carious Cervical Lesion
- What is being tested?
- bonding strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteThailand
- Study dates
- 10 Nov 2023to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Available for follow-up visits
- Have at least 28 teeth/ 20 teeth under occlusion
- Have at least 3 non-carious cervical lesions without peri-apical lesion. The lesion is not nearly exposed pulp and no history of previous restoration.
Who cannot join
- Rampant / uncontrolled caries
- Advanced untreated periodontal disease
- >2 cigarette packs/day
- Systemic or local disorders that could not undergo dental procedures
- Xerostomia
- Severe bruxism, clenching, TMD
Show all 9Show fewer
- Pregnancy at the time of screening
- Known history of sensitivity to resin or related materials
- Fixed orthodontic appliance or planning to have orthodontic treatment within 3 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Clinical Evaluation of Composite Restoration Using Two-steps Universal Adhesive in Non-carious Cervical Lesion: a Randomized Clinical Trial
The goal of this clinical study is to compare the clinical performance of a new 2-steps universal adhesive in patients with non-carious cervical lesions. The main question it aims to answer is: Is there any difference in clinical performance of a new 2-steps universal adhesives bonded with different etching strategies.
Participants will have restorations using a new 2-steps universal adhesives in different etching strategies.
- etch-and-rinse
- selective enamel etching
- self-etch
- Conditions
- Non-carious Cervical Lesion
- Being tested
- bonding strategies
- Keywords
- clinical trial, universal adhesive, etch-and-rinse, selective enamel etching, self-etch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bonding strategiesOther
The universal adhesive can be bonded using 3 different bonding strategies. Therefore, three bonding strategies will be assigned for 3 arms: etch-and-rinse, selective enamel etching, self-etch
| Study group | Role | What they receive |
|---|---|---|
| Etch-and-rinse | Experimental | G2 Bond Universal bonded to NCCL using etch-and-rinse technique Receives: Other: bonding strategies |
| Selective enamel etching | Experimental | G2 Bond Universal bonded to NCCL using selective enamel etching technique Receives: Other: bonding strategies |
| self-etch | Experimental | G2 Bond Universal bonded to NCCL using self-etch technique Receives: Other: bonding strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity (modified USPHS)
tooth sensitivity to hot/cold water, tactile
Measured: 3 years
retention (modified USPHS)
retention rate of the restoration that retain in the mouth after treatment
Measured: 3 years
secondary caries (modified USPHS)
caries recurrent rate after restoration
Measured: 3 years
Secondary outcomes (1)
marginal adaptation (modified USPHS)
the quality of the restoration margin
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start10 Nov 2023
- Primary completionNov 2026 (estimated)
- Study completionJan 2028 (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 Non-carious Cervical LesionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pipop Saikaew, Mahidol University
- Investigators
- Pipop Saikaew, PhD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573243
- Sponsor's protocol ID
- 2022/DT086
- Acronym
- NCCL
- Status last verified
- Feb 2025
- First submitted
- 7 Oct 2022
- Last updated
- 21 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Paris Matos T, Perdigao J, de Paula E, Coppla F, Hass V, Scheffer RF, Reis A, Loguercio AD. Five-year clinical evaluation of a universal adhesive: A randomized double-blind trial. Dent Mater. 2020 Nov;36(11):1474-1485. doi: 10.1016/j.dental.2020.08.007. Epub 2020 Sep 12.
PubMed 32933775
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Clinical Evaluation of Composite Restoration Using Two-steps Universal Adhesive in Non-carious Cervical Lesion: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05573243
- Acronym / sponsor ID
- NCCL / 2022/DT086
- Conditions
- Non-carious Cervical Lesion
- Keywords
- clinical trial, universal adhesive, etch-and-rinse, selective enamel etching, self-etch
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 10 Oct 2022 (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 goal of this clinical study is to compare the clinical performance of a new 2-steps universal adhesive in patients with non-carious cervical lesions. The main question it aims to answer is: Is there any difference in clinical performance of a new 2-steps universal adhesives bonded with different etching strategies.
Participants will have restorations using a new 2-steps universal adhesives in different etching strategies.
- etch-and-rinse
- selective enamel etching
- self-etch
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Etch-and-rinse | Experimental | Other: bonding strategiesG2 Bond Universal bonded to NCCL using etch-and-rinse technique |
| Selective enamel etching | Experimental | Other: bonding strategiesG2 Bond Universal bonded to NCCL using selective enamel etching technique |
| self-etch | Experimental | Other: bonding strategiesG2 Bond Universal bonded to NCCL using self-etch technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Available for follow-up visits
- Have at least 28 teeth/ 20 teeth under occlusion
- Have at least 3 non-carious cervical lesions without peri-apical lesion. The lesion is not nearly exposed pulp and no history of previous restoration.
Key exclusion criteria (9 listed)
- Rampant / uncontrolled caries
- Advanced untreated periodontal disease
- >2 cigarette packs/day
- Systemic or local disorders that could not undergo dental procedures
- Xerostomia
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 |
|---|---|---|
| bonding strategiesThe universal adhesive can be bonded using 3 different bonding strategies. Therefore, three bonding strategies will be assigned for 3 arms: etch-and-rinse, selective enamel etching, self-etch | Other | Etch-and-rinse, Selective enamel etching, self-etch |
Primary outcome
sensitivity (modified USPHS)
Time frame: 3 years
tooth sensitivity to hot/cold water, tactile
retention (modified USPHS)
Time frame: 3 years
retention rate of the restoration that retain in the mouth after treatment
secondary caries (modified USPHS)
Time frame: 3 years
caries recurrent rate after restoration
1 secondary outcome
marginal adaptation (modified USPHS)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Results publication: PubMed 32933775de Paris Matos T, Perdigao J, de Paula E, Coppla F, Hass V, Scheffer RF, Reis A, Loguercio AD. Five-year clinical evaluation of a universal adhesive: A randomized double-blind trial. Dent Mater. 2020 Nov;36(11):1474-1485. doi: 10.1016/j.dental.2020.08.007. Epub 2020 Sep 12.
- Individual participant dataSharing planned: No
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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.
Pipop Saikaew, PhD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bonding strategies in people with Non-carious Cervical Lesion, 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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 21 Feb 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
sensitivity (modified USPHS) (time frame: 3 years). The study lists 3 primary outcomes in all. 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 NCT05573243, 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 21 Feb 2025.