Dental WearNCT02961049
Influences of Gingival Cord Retractor in Retention Rate of Non-carious Cervical Lesions Restorations.
A study testing Gingival displacement, Enamel and dentin etched and Selective enamel etched in people with Dental Wear and Tooth Wear, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the retention rate of restorative protocols of Non-carious cervical lesion. The presence of gingival displacement with a retraction cord (yes or no) and the category of adhesive system (etch-and-rise and self-etching)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dental Wear, Tooth Wear
- What is being tested?
- Gingival displacement, Enamel and dentin etched and Selective enamel etched
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2016to Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Healthy volunteers; both genres; presence of at least four non carious cervical lesions of similar dimensions in the same arc and opposite quadrants; good oral hygiene.
Who cannot join
- Presence of cavities, cracks or enamel fractures; extensive or unsatisfactory restorations; recent restorations involving the labial surface; dentures or orthodontics; presence of periodontal disease and,or parafunctional habits; systemic disease and, or severe psychological; constant use of analgesic and, or anti-inflammatory or allergic response to dental products.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Uberlandia
Uberlândia, Minas Gerais, 381440617
Paulo V Soares, DDS, MS, PHD, +55 34 991615642, paulovsoares@yahoo.com.br
Alexandre C Machado, DDS, MS, +55 34 99133 5399, alexandrecoelhomachado@gmail.com
About this study
Official title: Influences of Gingival Cord Retractor in Retention Rate of Non-carious Cervical Lesions Restorations With Different Adhesive Systems. Randomized Clinical Trials.
The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the retention rate of restorative protocols of Non-carious cervical lesion. The presence of gingival displacement with a retraction cord (yes or no) and the category of adhesive system (etch-and-rise and self-etching) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.
Read the detailed description
Cervical wear is classified as a noncarious cervical lesion (NCCL), which is a pathological process characterized by loss of dental hard tissues near the cementoenamel junction (CEJ). The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the retention rate of restorative protocols of Non-carious cervical lesion. The presence of gingival displacement with a retraction cord and the category of adhesive system will be evaluated. Two hundred and twenty teeth, with NCCL of depth greater than 1.5mm, of 55 healthy patients of both sexes will be select. The teeth will be randomly divided into 4 different groups according to the gingival displacement with retraction cord (yes or no) and adhesive system category (etch-and-rise and self-etching). Data will be collected, tabulated and submitted to statistical analysis.
- Conditions
- Dental Wear, Tooth Wear
- Being tested
- Gingival displacement, Enamel and dentin etched, Selective enamel etched, Wash and dry, Total-etch adhesive system
- Medical subject headings
- Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival displacementProcedure or surgery
Gingival displacement with a gingival cord (#0, #00 or #000) with specific spatula.
Enamel and dentin etchedProcedure or surgery
Enamel and dentin etched with 35% phosphoric acid for 30 and 15 seconds, respectively.
Selective enamel etchedProcedure or surgery
Selective enamel etched with 35% phosphoric acid for 15 seconds.
Wash and dryProcedure or surgery
Wash and dry with absorbent paper.
Total-etch adhesive systemDevice
Two layers of pirmer/bond on enamel and dentin with a brush.
self-conditioning adhesive systemDevice
One layer of acid/pirmer on enamel and dentin with a brush following to one layer of bond with a brush.
PhotoactivatedProcedure or surgery
Photoactivated for 20 seconds
| Study group | Role | What they receive |
|---|---|---|
| Retraction and total-etch | Active comparator | Gingival displacement with a gingival cord (#0, #00 or #000) prior to the restoration. Application of total-etch adhesive system: enamel and dentin etched with 35% phosphoric acid, wash, dry, two layers of primer/bond application with a brush and photoactivated for 20 seconds. Receives: Procedure: Gingival displacement; Procedure: Enamel and dentin etched; Procedure: Wash and dry; Device: Total-etch adhesive system; Procedure: Photoactivated |
| No retraction and total-etch | Active comparator | Application of total-etch adhesive system: enamel and dentin etched with 35% phosphoric acid, wash, dry, two layers of primer/bond application with a brush and photoactivated for 20 seconds. Receives: Procedure: Enamel and dentin etched; Procedure: Wash and dry; Device: Total-etch adhesive system; Procedure: Photoactivated |
| Retraction and self-conditioning | Active comparator | Gingival displacement with a gingival cord (#0, #00 or #000) prior to the restoration. Application of self-conditioning adhesive system: selective enamel etched with 35% phosphoric acid, wash, dry, one layer of acid/pirmer on enamel and dentin with a brush, one layer of bond with a brush and photoactivated for 20 seconds. Receives: Procedure: Gingival displacement; Procedure: Selective enamel etched; Procedure: Wash and dry; Device: self-conditioning adhesive system; Procedure: Photoactivated |
| No retraction and self-conditioning | Active comparator | Application of self-conditioning adhesive system: selective enamel etched with 35% phosphoric acid, wash, dry, one layer of acid/pirmer on enamel and dentin with a brush, one layer of bond with a brush and photoactivated for 20 seconds. Receives: Procedure: Selective enamel etched; Procedure: Wash and dry; Device: self-conditioning adhesive system; Procedure: Photoactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of noncarious cervical lesions restorations according to the World Dental Federation criterion
Evaluate the success rate of NCCL restoration with a 36 mounths follow up
Measured: 36 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2017 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dental WearStudies 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
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PAULO VINICIUS SOARES, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961049
- Sponsor's protocol ID
- CAAE - 57032016.0.0000.5152
- Status last verified
- Nov 2016
- First submitted
- 8 Nov 2016
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Soares PV, Machado AC, Zeola LF, Souza PG, Galvao AM, Montes TC, Pereira AG, Reis BR, Coleman TA, Grippo JO. Loading and composite restoration assessment of various non-carious cervical lesions morphologies - 3D finite element analysis. Aust Dent J. 2015 Sep;60(3):309-16. doi: 10.1111/adj.12233.
PubMed 25312697Grippo JO, Simring M, Coleman TA. Abfraction, abrasion, biocorrosion, and the enigma of noncarious cervical lesions: a 20-year perspective. J Esthet Restor Dent. 2012 Feb;24(1):10-23. doi: 10.1111/j.1708-8240.2011.00487.x. Epub 2011 Nov 17.
PubMed 22296690Ritter AV, Grippo JO, Coleman TA, Morgan ME. Prevalence of carious and non-carious cervical lesions in archaeological populations from North America and Europe. J Esthet Restor Dent. 2009;21(5):324-34. doi: 10.1111/j.1708-8240.2009.00285.x.
PubMed 19796301Michael JA, Townsend GC, Greenwood LF, Kaidonis JA. Abfraction: separating fact from fiction. Aust Dent J. 2009 Mar;54(1):2-8. doi: 10.1111/j.1834-7819.2008.01080.x.
PubMed 19228125Loguercio AD, Luque-Martinez I, Lisboa AH, Higashi C, Queiroz VA, Rego RO, Reis A. Influence of Isolation Method of the Operative Field on Gingival Damage, Patients' Preference, and Restoration Retention in Noncarious Cervical Lesions. Oper Dent. 2015 Nov-Dec;40(6):581-93. doi: 10.2341/14-089-C. Epub 2015 Jul 9.
PubMed 26158415Kim SY, Lee KW, Seong SR, Lee MA, Lee IB, Son HH, Kim HY, Oh MH, Cho BH. Two-year clinical effectiveness of adhesives and retention form on resin composite restorations of non-carious cervical lesions. Oper Dent. 2009 Sep-Oct;34(5):507-15. doi: 10.2341/08-006C.
PubMed 19830963Peumans M, De Munck J, Mine A, Van Meerbeek B. Clinical effectiveness of contemporary adhesives for the restoration of non-carious cervical lesions. A systematic review. Dent Mater. 2014 Oct;30(10):1089-103. doi: 10.1016/j.dental.2014.07.007. Epub 2014 Aug 3.
PubMed 25091726
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influences of Gingival Cord Retractor in Retention Rate of Non-carious Cervical Lesions Restorations With Different Adhesive Systems. Randomized Clinical Trials.
- ClinicalTrials.gov ID
- NCT02961049
- Acronym / sponsor ID
- CAAE - 57032016.0.0000.5152
- Conditions
- Dental Wear, Tooth Wear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 10 Nov 2016 (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.
The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the retention rate of restorative protocols of Non-carious cervical lesion. The presence of gingival displacement with a retraction cord (yes or no) and the category of adhesive system (etch-and-rise and self-etching) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.
Detailed description
Cervical wear is classified as a noncarious cervical lesion (NCCL), which is a pathological process characterized by loss of dental hard tissues near the cementoenamel junction (CEJ). The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the retention rate of restorative protocols of Non-carious cervical lesion. The presence of gingival displacement with a retraction cord and the category of adhesive system will be evaluated. Two hundred and twenty teeth, with NCCL of depth greater than 1.5mm, of 55 healthy patients of both sexes will be select. The teeth will be randomly divided into 4 different groups according to the gingival displacement with retraction cord (yes or no) and adhesive system category (etch-and-rise and self-etching). Data will be collected, tabulated and submitted to statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Retraction and total-etch | Active comparator | Procedure: Gingival displacement, Procedure: Enamel and dentin etched, Procedure: Wash and dry, Device: Total-etch adhesive system, Procedure: PhotoactivatedGingival displacement with a gingival cord (#0, #00 or #000) prior to the restoration. Application of total-etch adhesive system: enamel and dentin etched with 35% phosphoric acid, wash, dry, two layers of primer/bond application with a brush and photoactivated for 20 seconds. |
| No retraction and total-etch | Active comparator | Procedure: Enamel and dentin etched, Procedure: Wash and dry, Device: Total-etch adhesive system, Procedure: PhotoactivatedApplication of total-etch adhesive system: enamel and dentin etched with 35% phosphoric acid, wash, dry, two layers of primer/bond application with a brush and photoactivated for 20 seconds. |
| Retraction and self-conditioning | Active comparator | Procedure: Gingival displacement, Procedure: Selective enamel etched, Procedure: Wash and dry, Device: self-conditioning adhesive system, Procedure: PhotoactivatedGingival displacement with a gingival cord (#0, #00 or #000) prior to the restoration. Application of self-conditioning adhesive system: selective enamel etched with 35% phosphoric acid, wash, dry, one layer of acid/pirmer on enamel and dentin with a brush, one layer of bond with a brush and photoactivated for 20 seconds. |
| No retraction and self-conditioning | Active comparator | Procedure: Selective enamel etched, Procedure: Wash and dry, Device: self-conditioning adhesive system, Procedure: PhotoactivatedApplication of self-conditioning adhesive system: selective enamel etched with 35% phosphoric acid, wash, dry, one layer of acid/pirmer on enamel and dentin with a brush, one layer of bond with a brush and photoactivated for 20 seconds. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers; both genres; presence of at least four non carious cervical lesions of similar dimensions in the same arc and opposite quadrants; good oral hygiene.
Key exclusion criteria (1 listed)
- Presence of cavities, cracks or enamel fractures; extensive or unsatisfactory restorations; recent restorations involving the labial surface; dentures or orthodontics; presence of periodontal disease and,or parafunctional habits; systemic disease and, or severe psychological; constant use of analgesic and, or anti-inflammatory or allergic response to dental products.
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 |
|---|---|---|
| Gingival displacementGingival displacement with a gingival cord (#0, #00 or #000) with specific spatula. | Procedure or surgery | Retraction and self-conditioning, Retraction and total-etch |
| Enamel and dentin etchedEnamel and dentin etched with 35% phosphoric acid for 30 and 15 seconds, respectively. | Procedure or surgery | No retraction and total-etch, Retraction and total-etch |
| Selective enamel etchedSelective enamel etched with 35% phosphoric acid for 15 seconds. | Procedure or surgery | No retraction and self-conditioning, Retraction and self-conditioning |
| Wash and dryWash and dry with absorbent paper. | Procedure or surgery | No retraction and self-conditioning, No retraction and total-etch, Retraction and self-conditioning, Retraction and total-etch |
| Total-etch adhesive systemTwo layers of pirmer/bond on enamel and dentin with a brush. | Device | No retraction and total-etch, Retraction and total-etch |
| self-conditioning adhesive systemOne layer of acid/pirmer on enamel and dentin with a brush following to one layer of bond with a brush. | Device | No retraction and self-conditioning, Retraction and self-conditioning |
| PhotoactivatedPhotoactivated for 20 seconds | Procedure or surgery | No retraction and self-conditioning, No retraction and total-etch, Retraction and self-conditioning, Retraction and total-etch |
Primary outcome
Success rate of noncarious cervical lesions restorations according to the World Dental Federation criterion
Time frame: 36 mounths
Evaluate the success rate of NCCL restoration with a 36 mounths follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- Results publication: PubMed 25312697Soares PV, Machado AC, Zeola LF, Souza PG, Galvao AM, Montes TC, Pereira AG, Reis BR, Coleman TA, Grippo JO. Loading and composite restoration assessment of various non-carious cervical lesions morphologies - 3D finite element analysis. Aust Dent J. 2015 Sep;60(3):309-16. doi: 10.1111/adj.12233.
- Results publication: PubMed 22296690Grippo JO, Simring M, Coleman TA. Abfraction, abrasion, biocorrosion, and the enigma of noncarious cervical lesions: a 20-year perspective. J Esthet Restor Dent. 2012 Feb;24(1):10-23. doi: 10.1111/j.1708-8240.2011.00487.x. Epub 2011 Nov 17.
- Results publication: PubMed 19796301Ritter AV, Grippo JO, Coleman TA, Morgan ME. Prevalence of carious and non-carious cervical lesions in archaeological populations from North America and Europe. J Esthet Restor Dent. 2009;21(5):324-34. doi: 10.1111/j.1708-8240.2009.00285.x.
- Results publication: PubMed 19228125Michael JA, Townsend GC, Greenwood LF, Kaidonis JA. Abfraction: separating fact from fiction. Aust Dent J. 2009 Mar;54(1):2-8. doi: 10.1111/j.1834-7819.2008.01080.x.
- Results publication: PubMed 26158415Loguercio AD, Luque-Martinez I, Lisboa AH, Higashi C, Queiroz VA, Rego RO, Reis A. Influence of Isolation Method of the Operative Field on Gingival Damage, Patients' Preference, and Restoration Retention in Noncarious Cervical Lesions. Oper Dent. 2015 Nov-Dec;40(6):581-93. doi: 10.2341/14-089-C. Epub 2015 Jul 9.
- Results publication: PubMed 19830963Kim SY, Lee KW, Seong SR, Lee MA, Lee IB, Son HH, Kim HY, Oh MH, Cho BH. Two-year clinical effectiveness of adhesives and retention form on resin composite restorations of non-carious cervical lesions. Oper Dent. 2009 Sep-Oct;34(5):507-15. doi: 10.2341/08-006C.
- Results publication: PubMed 25091726Peumans M, De Munck J, Mine A, Van Meerbeek B. Clinical effectiveness of contemporary adhesives for the restoration of non-carious cervical lesions. A systematic review. Dent Mater. 2014 Oct;30(10):1089-103. doi: 10.1016/j.dental.2014.07.007. Epub 2014 Aug 3.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gingival displacement, Enamel and dentin etched and Selective enamel etched in people with Dental Wear and Tooth Wear, run by Federal University of Uberlandia 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 1 inclusion and 1 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 11 Nov 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. 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?
Contact Paulo Vinícius Soares, DDS, MS, PHD (+55 34 991615642, paulovsaores@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of noncarious cervical lesions restorations according to the World Dental Federation criterion (time frame: 36 mounths). 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 NCT02961049, which also lists 7 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 11 Nov 2016.