Hypersensitivity DentinCDHNCT02931734
Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment
A study testing Resin modified glass ionomer, Potassium Nitrate 2% and Low level laser therapy in people with Hypersensitivity Dentin and Dentin Sensitivity, 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 various types of protocols and clinical efficacy in the reduction or even elimination of dentinal hypersensitivity by the agents Desensibilize KF - FGM Dental Products, Clinpro - 3M Company, Minnesota - USA, Photon… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypersensitivity Dentin, Dentin Sensitivity, Dentin Hypersensitivity
- What is being tested?
- Resin modified glass ionomer, Potassium Nitrate 2% and Low level laser therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2014to Jul 2015
- 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
- presence of dentin exposure lesions with clinical diagnosis of moderate or severe tooth sensitivity
- good oral hygiene.
Who cannot join
- cavities,
- presence of periodontal disease and or parafunctional habits,
- cracks or enamel fractures,
- extensive or unsatisfactory restorations,
- recent restorations involving the labial surface,
- dentures,
- orthodontics.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Uberlandia
Uberlândia, Minas Gerais, 38400-000
About this study
Official title: Analysis of the Association of Products for the Treatment of Cervical Dentin Hypersensitivity
The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the various types of protocols and clinical efficacy in the reduction or even elimination of dentinal hypersensitivity by the agents Desensibilize KF - FGM Dental Products, Clinpro - 3M Company, Minnesota - USA, Photon Laser III - DMC, Brazil, Desensibilize KF and laser, Desensibilize KF and Clinpro, laser and Clinpro and the association of all products. Data will be collected, tabulated and submitted to statistical analysis.
Read the detailed description
Cervical dentin hypersensitivity is a painful condition and is a clinical challenge due to different treatment strategies available. The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the various types of protocols and clinical efficacy in the reduction or even elimination of dentinal hypersensitivity. A hundred forty teeth of healthy patients of both sexes were selected. Visual Analog Scale was used pain (VAS) to measure the intensity of the patient's pain. The teeth will be randomly divided into 7 different groups according to the desensitization treatment under study: Desensibilize KF - FGM Dental Products, Clinpro - 3M Company, Minnesota - USA, Photon Laser III - DMC, Brazil, Desensibilize KF and laser, Desensibilize KF and Clinpro, laser and Clinpro and the association of all products. Data will be collected, tabulated and submitted to statistical analysis.
- Conditions
- Hypersensitivity Dentin, Dentin Sensitivity, Dentin Hypersensitivity, Dentine Hypersensitivity
- Being tested
- Resin modified glass ionomer, Potassium Nitrate 2%, Low level laser therapy
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin modified glass ionomerDrug
Also called Clinpro
Prophylaxis, washing and removing water excess , apply the Clinpro forming a uniform layer of 0.5mm, lightcure for 20 seconds
Potassium Nitrate 2%Drug
Also called Desensibilize KF
Prophylaxis, apply uniformly on the teeth, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.
Low level laser therapyProcedure or surgery
Also called Photon Lase III
Prophylaxis, applying infrared laser at low power in points: mesial, buccal, distal and in the apical point in the foyer of fornix with power of 110MW for 11 seconds at each point.
| Study group | Role | What they receive |
|---|---|---|
| Resin modified glass ionomer (RMGI) | Active comparator | Resin modified glass ionomer; an application every 48 hours; 4 sessions. Receives: Drug: Resin modified glass ionomer |
| Potassium Nitrate 2% (KF) | Active comparator | Potassium Nitrate and Sodium fluoride 2%; an application every 48 hours; 4 sessions. Receives: Drug: Potassium Nitrate 2% |
| Low level laser therapy - GaAlAs (LLLT) | Active comparator | Low level laser therapy - GaAlAs; an application every 48 hours; 4 sessions. Receives: Procedure: Low level laser therapy |
| RMGI and KF | Active comparator | Resin modified glass ionomer and potassium nitrate and sodium fluoride 2%; an application of the two associated products, every 48 hours; 4 sessions. Receives: Drug: Resin modified glass ionomer; Drug: Potassium Nitrate 2% |
| RMGI and LLLT | Active comparator | Resin modified glass ionomer and Low level laser therapy - GaAlAs; an application of the two associated products, every 48 hours; 4 sessions. Receives: Drug: Resin modified glass ionomer; Procedure: Low level laser therapy |
| KF and LLLT | Active comparator | Potassium Nitrate and Sodium fluoride 2% and Low level laser therapy - GaAlAs; an application of the two associated products, every 48 hours; 4 sessions. Receives: Drug: Potassium Nitrate 2%; Procedure: Low level laser therapy |
| RMGI, KF, LLLT | Active comparator | Resin modified glass ionomer, potassium nitrate and sodium fluoride 2% and Low level laser therapy - GaAlAs ; an application of the three associated products, every 48 hours; 4 sessions. Receives: Drug: Resin modified glass ionomer; Drug: Potassium Nitrate 2%; Procedure: Low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of cervical dentin hypersensitivity, measured by visual analog scale
Evaluate the reduction in Cervical Dentin Hypersensitivity with a 24 weeks follow up.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startOct 2014
- Primary completionJan 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hypersensitivity DentinStudies 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
- 140 participants (actual)
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
- Investigators
- Paulo V Soares, PhD, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931734
- Sponsor's protocol ID
- CAAE:35634614.2.0000.5152
- Acronym
- CDH
- Status last verified
- Oct 2016
- First submitted
- 3 Oct 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Orchardson R, Gangarosa LP Sr, Holland GR, Pashley DH, Trowbridge HO, Ashley FP, Kleinberg I, Zappa U. Dentine hypersensitivity-into the 21st century. Arch Oral Biol. 1994;39 Suppl:113S-119S. doi: 10.1016/0003-9969(94)90197-x. No abstract available.
PubMed 7702459Lussi A. Erosive tooth wear - a multifactorial condition of growing concern and increasing knowledge. Monogr Oral Sci. 2006;20:1-8. doi: 10.1159/000093343.
PubMed 16687880Davari A, Ataei E, Assarzadeh H. Dentin hypersensitivity: etiology, diagnosis and treatment; a literature review. J Dent (Shiraz). 2013 Sep;14(3):136-45.
PubMed 24724135Canadian Advisory Board on Dentin Hypersensitivity. Consensus-based recommendations for the diagnosis and management of dentin hypersensitivity. J Can Dent Assoc. 2003 Apr;69(4):221-6.
PubMed 12662460Coleman TA, Grippo JO, Kinderknecht KE. Cervical dentin hypersensitivity. Part II: Associations with abfractive lesions. Quintessence Int. 2000 Jul-Aug;31(7):466-73.
PubMed 11203968Brannstrom M. Sensitivity of dentine. Oral Surg Oral Med Oral Pathol. 1966 Apr;21(4):517-26. doi: 10.1016/0030-4220(66)90411-7. No abstract available.
PubMed 5218158Grippo 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 22296690Grippo JO. Biocorrosion vs. erosion: the 21st century and a time to change. Compend Contin Educ Dent. 2012 Feb;33(2):e33-7.
PubMed 23268573
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Association of Products for the Treatment of Cervical Dentin Hypersensitivity
- ClinicalTrials.gov ID
- NCT02931734
- Acronym / sponsor ID
- CDH / CAAE:35634614.2.0000.5152
- Conditions
- Hypersensitivity Dentin, Dentin Sensitivity, Dentin Hypersensitivity, Dentine Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Oct 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 various types of protocols and clinical efficacy in the reduction or even elimination of dentinal hypersensitivity by the agents Desensibilize KF - FGM Dental Products, Clinpro - 3M Company, Minnesota - USA, Photon Laser III - DMC, Brazil, Desensibilize KF and laser, Desensibilize KF and Clinpro, laser and Clinpro and the association of all products. Data will be collected, tabulated and submitted to statistical analysis.
Detailed description
Cervical dentin hypersensitivity is a painful condition and is a clinical challenge due to different treatment strategies available. The aim of this study is through a randomized clinical trial, double blind, splith-mouth, evaluate the various types of protocols and clinical efficacy in the reduction or even elimination of dentinal hypersensitivity. A hundred forty teeth of healthy patients of both sexes were selected. Visual Analog Scale was used pain (VAS) to measure the intensity of the patient's pain. The teeth will be randomly divided into 7 different groups according to the desensitization treatment under study: Desensibilize KF - FGM Dental Products, Clinpro - 3M Company, Minnesota - USA, Photon Laser III - DMC, Brazil, Desensibilize KF and laser, Desensibilize KF and Clinpro, laser and Clinpro and the association of all products. 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
- 7
| Arm | Type | Receives |
|---|---|---|
| Resin modified glass ionomer (RMGI) | Active comparator | Drug: Resin modified glass ionomerResin modified glass ionomer; an application every 48 hours; 4 sessions. |
| Potassium Nitrate 2% (KF) | Active comparator | Drug: Potassium Nitrate 2%Potassium Nitrate and Sodium fluoride 2%; an application every 48 hours; 4 sessions. |
| Low level laser therapy - GaAlAs (LLLT) | Active comparator | Procedure: Low level laser therapyLow level laser therapy - GaAlAs; an application every 48 hours; 4 sessions. |
| RMGI and KF | Active comparator | Drug: Resin modified glass ionomer, Drug: Potassium Nitrate 2%Resin modified glass ionomer and potassium nitrate and sodium fluoride 2%; an application of the two associated products, every 48 hours; 4 sessions. |
| RMGI and LLLT | Active comparator | Drug: Resin modified glass ionomer, Procedure: Low level laser therapyResin modified glass ionomer and Low level laser therapy - GaAlAs; an application of the two associated products, every 48 hours; 4 sessions. |
| KF and LLLT | Active comparator | Drug: Potassium Nitrate 2%, Procedure: Low level laser therapyPotassium Nitrate and Sodium fluoride 2% and Low level laser therapy - GaAlAs; an application of the two associated products, every 48 hours; 4 sessions. |
| RMGI, KF, LLLT | Active comparator | Drug: Resin modified glass ionomer, Drug: Potassium Nitrate 2%, Procedure: Low level laser therapyResin modified glass ionomer, potassium nitrate and sodium fluoride 2% and Low level laser therapy - GaAlAs ; an application of the three associated products, every 48 hours; 4 sessions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- presence of dentin exposure lesions with clinical diagnosis of moderate or severe tooth sensitivity
- good oral hygiene.
Key exclusion criteria (7 listed)
- cavities,
- presence of periodontal disease and or parafunctional habits,
- cracks or enamel fractures,
- extensive or unsatisfactory restorations,
- recent restorations involving the labial surface,
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 |
|---|---|---|
| Resin modified glass ionomerAlso: ClinproProphylaxis, washing and removing water excess , apply the Clinpro forming a uniform layer of 0.5mm, lightcure for 20 seconds | Drug | RMGI and KF, RMGI and LLLT, RMGI, KF, LLLT, Resin modified glass ionomer (RMGI) |
| Potassium Nitrate 2%Also: Desensibilize KFProphylaxis, apply uniformly on the teeth, wait 10 minutes, remove the gel from the teeth with cotton and abundant water. | Drug | KF and LLLT, Potassium Nitrate 2% (KF), RMGI and KF, RMGI, KF, LLLT |
| Low level laser therapyAlso: Photon Lase IIIProphylaxis, applying infrared laser at low power in points: mesial, buccal, distal and in the apical point in the foyer of fornix with power of 110MW for 11 seconds at each point. | Procedure or surgery | KF and LLLT, Low level laser therapy - GaAlAs (LLLT), RMGI and LLLT, RMGI, KF, LLLT |
Primary outcome
Level of cervical dentin hypersensitivity, measured by visual analog scale
Time frame: 24 weeks
Evaluate the reduction in Cervical Dentin Hypersensitivity with a 24 weeks follow up.
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 14 Oct 2016.
- Background: PubMed 7702459Orchardson R, Gangarosa LP Sr, Holland GR, Pashley DH, Trowbridge HO, Ashley FP, Kleinberg I, Zappa U. Dentine hypersensitivity-into the 21st century. Arch Oral Biol. 1994;39 Suppl:113S-119S. doi: 10.1016/0003-9969(94)90197-x. No abstract available.
- Background: PubMed 16687880Lussi A. Erosive tooth wear - a multifactorial condition of growing concern and increasing knowledge. Monogr Oral Sci. 2006;20:1-8. doi: 10.1159/000093343.
- Background: PubMed 24724135Davari A, Ataei E, Assarzadeh H. Dentin hypersensitivity: etiology, diagnosis and treatment; a literature review. J Dent (Shiraz). 2013 Sep;14(3):136-45.
- Background: PubMed 12662460Canadian Advisory Board on Dentin Hypersensitivity. Consensus-based recommendations for the diagnosis and management of dentin hypersensitivity. J Can Dent Assoc. 2003 Apr;69(4):221-6.
- Background: PubMed 11203968Coleman TA, Grippo JO, Kinderknecht KE. Cervical dentin hypersensitivity. Part II: Associations with abfractive lesions. Quintessence Int. 2000 Jul-Aug;31(7):466-73.
- Background: PubMed 5218158Brannstrom M. Sensitivity of dentine. Oral Surg Oral Med Oral Pathol. 1966 Apr;21(4):517-26. doi: 10.1016/0030-4220(66)90411-7. No abstract available.
- Background: 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.
- Background: PubMed 23268573Grippo JO. Biocorrosion vs. erosion: the 21st century and a time to change. Compend Contin Educ Dent. 2012 Feb;33(2):e33-7.
- 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.
Paulo V Soares, PhD principal investigator
Federal University of Uberlandia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin modified glass ionomer, Potassium Nitrate 2% and Low level laser therapy in people with Hypersensitivity Dentin and Dentin Sensitivity, 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 2 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: finished, as of the sponsor's last update on 14 Oct 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?
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?
Level of cervical dentin hypersensitivity, measured by visual analog scale (time frame: 24 weeks). 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 NCT02931734, which also lists 8 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 14 Oct 2016.