Non-carious Cervical LesionsNCT03086720

Deproteinization as a Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions

A study testing Sodium hypochlorite and Water in people with Non-carious Cervical Lesions, run by Federal University of Pelotas at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This study will verify the effect of the application of a substance (10% sodium hypoclorite -NaOCL) in dentin on noncarious cervical lesions, with the aim of increasing the longevity of the restorations performed in this type of lesion. 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?: Sodium hypochlorite and Water
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteBrazil
Study dates: Jul 2012to Dec 2018
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 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

Federal University of Pelotas - School of Dentistry
Pelotas, Rio Grande do Sul, 96015560

Other trials in Brazil

About this study

Official title: Effect of Sodium Hypochlorite Pre-treatment on the Retention of Restorations for Non-carious Cervical Lesions: A Randomized Controlled Trial

The hypothesis of the present study is that the application of deproteinization solution after acid etching does not influence the failure rate of the restorations.

Read the detailed description

The purpose of this study will be to evaluate the failure rates of composite restorations of non-carious cervical lesions (NCCL) performed with or without the pre-treatment with 10% sodium hypochlorite (NaOCl) on etched dentin.

A randomized controlled split-mouth and double blind clinical trial will be carried out. Patients with at least two NCCL will be selected. Each patient will be received at least one pair of composite restorations (Filtek Z350/3M ESPE), bonded either with 2 techniques: control (acid etching + placebo solution for 60 seconds + Adper Single Bond 2/3M ESPE) or experimental (acid etching + 10% NaOCl for 60 seconds + Adper Single Bond 2). A calibrated examiner will be evaluated the restorations (baseline, 6-, 12-, 24- and 36-month) using the FDI criteria. The primary outcome is retention of the restoration.

Conditions: Non-carious Cervical Lesions
Being tested: Sodium hypochlorite, Water
Keywords: Adhesive system, Controlled clinical trial, Dental restoration, Noncarious cervical lesions, Dental restoration failure, Sodium hypochlorite

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sodium hypochloriteProcedure or surgery
Application of 10% sodium hypochlorite (60 seconds) after the etching procedure and before the adhesive system.
WaterProcedure or surgery
Treatment of acid etched dentin with sterilized water for 60 s before adhesive system application

Study groups in NCT03086720
Study group	Role	What they receive
Sodium hypochlorite	Experimental	Dentin pre-treatment with a experimental solution (sodium hupochlorite), after the dentin acid etching Receives: Procedure: Sodium hypochlorite
Water	Placebo comparator	Application of water (placebo) after dentin acid etching Receives: Procedure: Water

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
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, 24, 36 and 60 months

Secondary outcomes (2)

Change from baseline in Post-operative sensitivity
At each time-point, patients will be recalled and interviewed regarding any symptom related to each restorations placed.
Measured: 6, 12, 24, 36 and 60 months
Change from baseline in marginal staining rates
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, 24, 36 and 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Dec 2018

First posted22 Mar 2017
Study startJul 2012
Primary completionDec 2018 (estimated)
Study completionDec 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03086720
Sponsor's protocol ID: UFPEL- PPGO 0019
Status last verified: Mar 2017
First submitted: 16 Mar 2017
Last updated: 22 Mar 2017
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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
Favetti M, Schroeder T, Montagner AF, Correa MB, Pereira-Cenci T, Cenci MS. Effectiveness of pre-treatment with chlorhexidine in restoration retention: A 36-month follow-up randomized clinical trial. J Dent. 2017 May;60:44-49. doi: 10.1016/j.jdent.2017.02.014. Epub 2017 Feb 22.
PubMed 28237629
Favetti M, Schroeder T, Montagner AF, Moraes RR, Pereira-Cenci T, Cenci MS. NaOCl Application after Acid Etching and Retention of Cervical Restorations: A 3-Year Randomized Clinical Trial. Oper Dent. 2022 May 1;47(3):268-278. doi: 10.2341/20-166-C.
PubMed 35584331

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Two Year Clinical Performance of Ion-releasing and Non Ion-releasing Composite Restorative Systems in Restoring Cervical Carious Lesions.
Class V Dental Caries
Recruiting
Root Coverage Performance of Restorative Materials in Class V Cavities
Gingival Recession, Non-Carious Cervical Lesions (NCCLs)
Active, not recruiting
Different Modes of Universal Adhesive in Smokers and Non-Smokers
Healthy Participant
Not yet recruiting
Evaluation of Different Non-Invasive Methods in the Treatment of Dentin Hypersensitivity Associated With Non-Carious Cervical Lesions: A Split-Mouth Clinical Study
Non-Carious Cervical Lesions (NCCLs), Dentin Hypersensitivity
Active, not recruiting
Evaluating Universal Adhesives in Cervical Lesions
Cervical Lesion, Dental

All Non-carious Cervical Lesions trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Sodium Hypochlorite Pre-treatment on the Retention of Restorations for Non-carious Cervical Lesions: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03086720
Acronym / sponsor ID: UFPEL- PPGO 0019
Conditions: Non-carious Cervical Lesions
Keywords: Adhesive system, Controlled clinical trial, Dental restoration, Noncarious cervical lesions, Dental restoration failure, Sodium hypochlorite
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: Federal University of PelotasUniversity, hospital or other
Study start: Jul 2012
Primary completion: Dec 2018 (estimated)
Study completion: Dec 2018 (estimated)
First posted: 22 Mar 2017 (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 hypothesis of the present study is that the application of deproteinization solution after acid etching does not influence the failure rate of the restorations.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sodium hypochlorite	Experimental	Procedure: Sodium hypochloriteDentin pre-treatment with a experimental solution (sodium hupochlorite), after the dentin acid etching
Water	Placebo comparator	Procedure: WaterApplication 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 (4 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 in the facial surface of the teeth with sometimes a small part extending interproximally; Patients with good periodontal heath.

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
Sodium hypochloriteApplication of 10% sodium hypochlorite (60 seconds) after the etching procedure and before the adhesive system.	Procedure or surgery	Sodium hypochlorite
WaterTreatment 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
Time frame: 6, 12, 24, 36 and 60 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
Time frame: 6, 12, 24, 36 and 60 months
Change from baseline in marginal staining rates
Time frame: 6, 12, 24, 36 and 60 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
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.
Background: PubMed 28237629Favetti M, Schroeder T, Montagner AF, Correa MB, Pereira-Cenci T, Cenci MS. Effectiveness of pre-treatment with chlorhexidine in restoration retention: A 36-month follow-up randomized clinical trial. J Dent. 2017 May;60:44-49. doi: 10.1016/j.jdent.2017.02.014. Epub 2017 Feb 22.
Derived from this study: PubMed 35584331Favetti M, Schroeder T, Montagner AF, Moraes RR, Pereira-Cenci T, Cenci MS. NaOCl Application after Acid Etching and Retention of Cervical Restorations: A 3-Year Randomized Clinical Trial. Oper Dent. 2022 May 1;47(3):268-278. doi: 10.2341/20-166-C.
Individual participant dataSharing planned: No

Related trials for Non-carious Cervical Lesions

Active, not recruiting
Two Year Clinical Performance of Ion-releasing and Non Ion-releasing Composite Restorative Systems in Restoring Cervical Carious Lesions.
Class V Dental Caries
Recruiting
Root Coverage Performance of Restorative Materials in Class V Cavities
Gingival Recession, Non-Carious Cervical Lesions (NCCLs)
Active, not recruiting
Different Modes of Universal Adhesive in Smokers and Non-Smokers
Healthy Participant
Not yet recruiting
Evaluation of Different Non-Invasive Methods in the Treatment of Dentin Hypersensitivity Associated With Non-Carious Cervical Lesions: A Split-Mouth Clinical Study
Non-Carious Cervical Lesions (NCCLs), Dentin Hypersensitivity
Active, not recruiting
Evaluating Universal Adhesives in Cervical Lesions
Cervical Lesion, Dental

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, Federal University of Pelotas

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sodium hypochlorite and Water 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 4 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: status not confirmed, as of the sponsor's last update on 22 Mar 2017. 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?

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?

Change from baseline in Retention rates of the restoration (time frame: 6, 12, 24, 36 and 60 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 NCT03086720, which also lists 3 linked publications.

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 22 Mar 2017.