Non-carious Cervical LesionsNCT01947192
Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions
A study testing Treatment with chlorhexidine and Water pre-treatment in people with Non-carious Cervical Lesions, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
This study aims to evaluate the effect of chlorhexidine digluconate (CRX) application in etched dentin on the retention of noncarious cervical lesions restorations. A randomized controlled split-mouth and blind trial will be carried out. Patients with at least two non-carious cervical lesions (NCL) will be selected. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-carious Cervical Lesions
- What is being tested?
- Treatment with chlorhexidine and Water pre-treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Nov 2012
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients presenting at least two non-carious cervical lesions (NCL) in anterior, canine or pre-molars;
- Patients who had more than 20 teeth in the mouth;
- Patients who were at least 18 years of age at the time of treatment and capable to understand and sign the written informed consent;
- NCL with at least 1 mm of depth in a vital permanent incisor, canine or premolar of the upper as the lower jaw.
- NCL in the facial surface of the teeth with sometimes a small part extending interproximally;
- Patients with good periodontal heath.
Who cannot join
- Patients with smoking habits, practicing bruxism, severe systemic diseases, using active orthodontic treatment, malocclusion (Angle Class II or Class III);
- Tooth with the NCL with the absent of antagonist;
- NCL wear facets upper than 50% of the incisal/occlusion surface, as a result of tooth attrition;
- Presence of caries or restorations in the area to be treated;
- Full-mouth visible plaque index (VPI) or full-mouth gingival bleeding index upper than 20%, probing depth and clinical attachment loss values exceeding 4 mm with bleeding on probing;
- Unwillingness to return for follow-ups or refuse to participate.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry, Federal University of Pelotas
Pelotas, Rio Grande do Sul, 96015-560
About this study
Official title: Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions and Failure-prognostic Variables: A Randomized Controlled Trial
This study aims to evaluate the effect of chlorhexidine digluconate (CRX) application in etched dentin on the retention of noncarious cervical lesions restorations.
A randomized controlled split-mouth and blind trial will be carried out. Patients with at least two non-carious cervical lesions (NCL) will be selected. NCL will be randomly assigned according the type of teeth (incisors, canine or pre-molars) into two groups: control or experimental group (application of 2% CRX for 60 seconds after the acid etching procedure). Class V restorations will be performed out with an etch-and-rinse adhesive system (Adper Single Bond 2-3M ESPE) and a composite resin (Filtek Z350-3M ESPE) according the manufacture instructions, by previously trained operators. The restorations will be evaluated by a calibrate examiner at 1 week (baseline), and 6-month, 12-month and 24-month, using the World Dental Federation (FDI) criteria. The outcome is retention of the restoration.
- Conditions
- Non-carious Cervical Lesions
- Being tested
- Treatment with chlorhexidine, Water pre-treatment
- Keywords
- Chlorhexidine, Matrix metalloproteinases (MMP) inhibitor, Adhesive system, Controlled clinical trial, Dental restoration, Noncarious cervical lesions, Dental restoration failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with chlorhexidineProcedure or surgery
Application of 2% chlorhexidine digluconate (60 seconds) after the etching procedure and before the adhesive system.
Water pre-treatmentProcedure or surgery
Treatment of acid etched dentin with sterilized water for 60 s before adhesive system application
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine | Experimental | Dentin pre-treatment with a experimental solution (chlorhexidine), after the dentin acid etching Receives: Procedure: Treatment with chlorhexidine |
| Water | Placebo comparator | Application of water (placebo) after dentin acid etching. Receives: Procedure: Water pre-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Retention rates of the restoration at 24 months
Patients will be reevaluated at each specified time point and all restoration sites will be evaluated to check if the restoration will be still in place, or if it is missing, or if there is partial retention
Measured: 6, 12 and 24 months
Secondary outcomes (2)
Change from baseline in Post-operative sensitivity at 6-month
At each time-point, patients will be recalled and interviewed regarding any symptom related to each restorations placed.
Measured: baseline and 6-month
Change from baseline in marginal staining rates at 6. 12 and 24 months
At each time-point, patients will be recalled and restorations will be reassessed in order to record changes in the rates of marginal staining, using the World Dental Federation (FDI) criteria for restorations assessment (Hickel et al 2010).
Measured: 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startNov 2011
- Primary completionNov 2012
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 LesionsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximiliano Sergio Cenci, Federal University of Pelotas
- Investigators
- Maximiliano Cenci, PhD, Principal investigator, School of Dentistry-UFPel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947192
- Sponsor's protocol ID
- PPGO0017
- Status last verified
- Feb 2016
- First submitted
- 15 Aug 2013
- Last updated
- 24 Feb 2016
- Results posted
- No
Publications
Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
PubMed 20628774
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions and Failure-prognostic Variables: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01947192
- Acronym / sponsor ID
- PPGO0017
- Conditions
- Non-carious Cervical Lesions
- Keywords
- Chlorhexidine, Matrix metalloproteinases (MMP) inhibitor, Adhesive system, Controlled clinical trial, Dental restoration, Noncarious cervical lesions, Dental restoration failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- First posted
- 20 Sep 2013 (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.
This study aims to evaluate the effect of chlorhexidine digluconate (CRX) application in etched dentin on the retention of noncarious cervical lesions restorations.
A randomized controlled split-mouth and blind trial will be carried out. Patients with at least two non-carious cervical lesions (NCL) will be selected. NCL will be randomly assigned according the type of teeth (incisors, canine or pre-molars) into two groups: control or experimental group (application of 2% CRX for 60 seconds after the acid etching procedure). Class V restorations will be performed out with an etch-and-rinse adhesive system (Adper Single Bond 2-3M ESPE) and a composite resin (Filtek Z350-3M ESPE) according the manufacture instructions, by previously trained operators. The restorations will be evaluated by a calibrate examiner at 1 week (baseline), and 6-month, 12-month and 24-month, using the World Dental Federation (FDI) criteria. The outcome is retention of the restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine | Experimental | Procedure: Treatment with chlorhexidineDentin pre-treatment with a experimental solution (chlorhexidine), after the dentin acid etching |
| Water | Placebo comparator | Procedure: Water pre-treatmentApplication of water (placebo) after dentin acid etching. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients presenting at least two non-carious cervical lesions (NCL) in anterior, canine or pre-molars;
- Patients who had more than 20 teeth in the mouth;
- Patients who were at least 18 years of age at the time of treatment and capable to understand and sign the written informed consent;
- NCL with at least 1 mm of depth in a vital permanent incisor, canine or premolar of the upper as the lower jaw.
- NCL in the facial surface of the teeth with sometimes a small part extending interproximally;
Key exclusion criteria (6 listed)
- Patients with smoking habits, practicing bruxism, severe systemic diseases, using active orthodontic treatment, malocclusion (Angle Class II or Class III);
- Tooth with the NCL with the absent of antagonist;
- NCL wear facets upper than 50% of the incisal/occlusion surface, as a result of tooth attrition;
- Presence of caries or restorations in the area to be treated;
- Full-mouth visible plaque index (VPI) or full-mouth gingival bleeding index upper than 20%, probing depth and clinical attachment loss values exceeding 4 mm with bleeding on probing;
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 |
|---|---|---|
| Treatment with chlorhexidineApplication of 2% chlorhexidine digluconate (60 seconds) after the etching procedure and before the adhesive system. | Procedure or surgery | Chlorhexidine |
| Water pre-treatmentTreatment of acid etched dentin with sterilized water for 60 s before adhesive system application | Procedure or surgery | Water |
Primary outcome
Change from baseline in Retention rates of the restoration at 24 months
Time frame: 6, 12 and 24 months
Patients will be reevaluated at each specified time point and all restoration sites will be evaluated to check if the restoration will be still in place, or if it is missing, or if there is partial retention
2 secondary outcomes
Change from baseline in Post-operative sensitivity at 6-month
Time frame: baseline and 6-month
Change from baseline in marginal staining rates at 6. 12 and 24 months
Time frame: 6, 12 and 24 months
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 24 Feb 2016.
- Background: PubMed 20628774Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
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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.
Maximiliano Cenci, PhD principal investigator
School of Dentistry-UFPel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with chlorhexidine and Water pre-treatment in people with Non-carious Cervical Lesions, run by Federal University of Pelotas at 1 site in Brazil.
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 6 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 24 Feb 2016. 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 Brazil. 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?
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?
Change from baseline in Retention rates of the restoration at 24 months (time frame: 6, 12 and 24 months). 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 NCT01947192, 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 24 Feb 2016.