Dentinal HypersensitivityNCT06685016
Evaluation of Dental and Periodontal Health After IPR in Patients in Orthodontic Treatment With Clear Aligners
A study testing Evaluation of Dentin hypersensitivity with VAS scale in people with Dentinal Hypersensitivity and Plaque, Dental, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
This study aimed to evaluate dental and periodontal health after interproximal enamel reduction and to compare Laser diode (a device used in the Orthodontic Program) and sodium fluoride (often used in the Orthodontic Program and in the Material Dental Program). Read more about this study
- Who is it for?
- Ages 17 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentinal Hypersensitivity, Plaque, Dental, Bleeding Gum
- What is being tested?
- Evaluation of Dentin hypersensitivity with VAS scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jun 2023to Dec 2024
- 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 17 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- to be in orthodontic treatment with clear aligners and this treatment requires interproximal enamel reduction;
- permanent dentition;
- good oral and periodontal health.
Who cannot join
- enamel defects;
- cervical caries;
- periodontal disease;
- history of trauma or craniofacial anomalies;
- pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Multidisciplinary department of Medical-Surgical and Dental Specialties
Naples, 80138
Vincenzo Grassia, DDs, PhD, +39 0815665524, vincenzo.grassia@unicampania.it
About this study
Official title: Evaluation of Dental and Periodontal Health After Interproximal Enamel Reduction, in Patients in Orthodontic Treatment With Clear Aligners, and Comparison Between Laser Diode and Sodium Fluoride for the Treatment of Dentin Hypersensitivity
This study aimed to evaluate dental and periodontal health after interproximal enamel reduction and to compare Laser diode (a device used in the Orthodontic Program) and sodium fluoride (often used in the Orthodontic Program and in the Material Dental Program). The hypothesis was that the intervention groups would show a lower dentin hypersensitivity incidence than the control group during orthodontic treatment.
Read the detailed description
Interproximal enamel reduction (IPR) is a common procedure used during orthodontic treatment aimed to reduce mesio-distal tooth size dimensions to address lack of space (mild and moderate crowding), Bolton tooth-size discrepancy, correction of morphologic anomalies, tooth reshaping and management of gingival papilla. It is a practice that also offers an attractive alternative to overcome difficulty when extracting premolars and resolve the instability of overexpansion in non- extraction cases, improving the stability of the arches.
IPR may be exploited inconjunction with fixed appliance treatment, although its application with removable appliance treatment such as clear aligners is commonplace.
Clinically, the most accepted IPR techniques include air-rotor stripping with fine tungsten-carbide or diamond burs, handpiece or contra-angle-mounted diamond-coated disks, and handheld or motor- driven abrasive metal strips.
Some of these techniques can cause deep furrows and scratches that cannot be removed by polishing . In addition, these surface irregularities could promote the adherence of plaque bacteria and induce iatrogenic damage, such as dental caries, gingival inflammation, periodontal tissue breakdown, gingival recession and increased sensitivity of the shaped teeth to hot and cold temperatures.
Sometimes, after IPR, it is possible to have dentin hypersensitivity (DH), attributed to exposure to dentinal tubules. This clinical condition is influenced by various factors, including patient' s age, the severity of crowding, pathological tooth wear, hypersensitivity before treatment and the amount of the removed enamel.
DH can be defined as "short and sharp pain due to exposure of the dentinal tubules in response to thermal, evaporative, tactile, osmotic or chemical stimuli". The hydrodynamic theory proposed by Brännström is the most accepted theory to explain the DH mechanism. According to this theory, external stimuli, leading to fluid movement within the dentinal tubules and this movement indirectly stimulates the pulp nerve ends, causing a painful sensation.
Several methods can perform DH treatment. Based on the mode of their administration, the desensitizing treatment can be classified into at-home therapy or in-office therapy categories. At- home desensitizing products include toothpaste, mouthwashes and chewing gums. In contrast, in- office desensitizing products can be gels, solutions, varnishes, resin sealers, glass ionomers, dentin adhesives and more sophisticated laser techniques. In addition, eliminating of nociceptive stimuli, there are two main treatment strategies: modifying nervous response by preventing or reducing neuronal transmission and occluding the permeable dentinal tubules.
Potassium salts were thought to decrease the excitability of pulpal nerves and result in a reduction in DH. Still, clinical trials with sound design have failed to provide evidence that potassium is effective in desensitizing teeth. Potassium salts likely reduced the perception of dentin sensitivity through a placebo effect. The proposed mechanism for glutaraldehyde, another agent used for the treatment of DH, involves the reaction with serum albumin in dentinal tubule fluid, leading to precipitate formation within tubules and subsequent narrowing or blocking of the tubules. Strontium salts, fluoride, oxalate and arginine/calcium can occlude the tubules and form a protective layer on the dentin surface. Dental adhesives and resin sealants can occlude the dentinal tubules by forming a physical barrier thus blocking the movement of dentinal fluid and preventing direct stimulation of odontoblastic processes. The action of glass ionomers in the management of DH can also lead to occlusion of open dentinal tubules by precipitating a hydroxycarbonate apatite layer over the previously patent tubule openings. Laser treatment has been investigated as a prospective treatment for DH. Several studies suggest that the low-power laser could suppress the excitability of the pulpal nerves. Higher output laser is thought to reduce symptoms of DH by inducing the occlusion of dentin tubules.
Pain associated with DH may reduce the quality of life, but does not compromise people's health. Currently, no studies that have tested desensitizing substances to reduce or eliminate DH that can occur after IPR.
- Conditions
- Dentinal Hypersensitivity, Plaque, Dental, Bleeding Gum
- Being tested
- Evaluation of Dentin hypersensitivity with VAS scale
- Keywords
- Clear Aligners, Interproximal enamel reduction
- Medical subject headings
- Dental Plaque, Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of Dentin hypersensitivity with VAS scaleDiagnostic test
Dentin hypersensitivity and periodontal indices evaluation are performed after and before IPR, at 1 week, 1 month and 3 months
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Subjects will not receive any treatment Receives: Diagnostic Test: Evaluation of Dentin hypersensitivity with VAS scale |
| Laser Diode Group | Experimental | Subjects treated with Laser Diode Receives: Diagnostic Test: Evaluation of Dentin hypersensitivity with VAS scale |
| Sodium Fluoride Group | Experimental | Subjects with a sodium fluoride gel treatment. Receives: Diagnostic Test: Evaluation of Dentin hypersensitivity with VAS scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assestment of DH after IPR
Dentin hypersensitivity will be assessed before and after interproximal enamel reduction and after the application of therapeutic protocols. Dentin hypersensitivity will be performed with the evaporative method. After isolation of the adjacent teeth, the air syringe will be placed 2-3 mm from the tooth surface, at a perpendicular position of 90º, and a continuous air blast of 45 to 60 psi (3.10 to 4.13 Bar) should be applied for 2-3 seconds. The air temperature should be around 20°C (19-22°C). The discomfort will be expressed in a numerical 0-10 cm visual analog scale (VAS) where the value 0 is correlated with no discomfort and the value 10 for utmost discomfort or intolerable pain during application of the stimulus. Each patient will place a vertical mark on the VAS to indicate the intensity of his or her level of sensitivity after the applied stimuli.
Measured: from 3 to 4 months
Reduction of the Dentin Hypersensitivity
. Dentin hypersensitivity will be performed with the evaporative method. After isolation of the adjacent teeth, the air syringe will be placed 2-3 mm from the tooth surface, at a perpendicular position of 90º, and a continuous air blast of 45 to 60 psi (3.10 to 4.13 Bar) should be applied for 2-3 seconds. The air temperature should be around 20°C (19-22°C). The discomfort will be expressed in a numerical 0-10 cm visual analog scale (VAS) where the value 0 is correlated with no discomfort and the value 10 for utmost discomfort or intolerable pain during application of the stimulus. Each patient will place a vertical mark on the VAS to indicate the intensity of his or her level of sensitivity after the applied stimuli.
Measured: from 3 to 4 months
Secondary outcomes (1)
Evaluation of Dentin hypersensitivity after the application of therapeutic protocols.
Evaluate Dentin Hypersensitivity in the control group and the treated groups,with the evaporative method. After isolation of the adjacent teeth, the air syringe will be placed 2-3 mm from the tooth surface, at a perpendicular position of 90º, and a continuous air blast of 45 to 60 psi (3.10 to 4.13 Bar) should be applied for 2-3 seconds. The air temperature should be around 20°C (19-22°C). The discomfort will be expressed in a numerical 0-10 cm visual analog scale (VAS) where the value 0 is correlated with no discomfort and the value 10 for utmost discomfort or intolerable pain during application of the stimulus. Each patient will place a vertical mark on the VAS to indicate the intensity of his or her level of sensitivity after the applied stimuli.
To assess in which group it reduces or is eliminated more quickly.
Measured: from 3 to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start24 Jun 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Dentinal HypersensitivityStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Grassia, University of Campania Luigi Vanvitelli
- Investigators
- Vincenzo Grassia, DDs,PhD, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685016
- Sponsor's protocol ID
- 0016945/i
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu XX, Tenenbaum HC, Wilder RS, Quock R, Hewlett ER, Ren YF. Pathogenesis, diagnosis and management of dentin hypersensitivity: an evidence-based overview for dental practitioners. BMC Oral Health. 2020 Aug 6;20(1):220. doi: 10.1186/s12903-020-01199-z.
PubMed 32762733Poulsen S, Errboe M, Lescay Mevil Y, Glenny AM. Potassium containing toothpastes for dentine hypersensitivity. Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD001476. doi: 10.1002/14651858.CD001476.pub2.
PubMed 16855970Orchardson R, Gillam DG. The efficacy of potassium salts as agents for treating dentin hypersensitivity. J Orofac Pain. 2000 Winter;14(1):9-19.
PubMed 11203743Livas C, Jongsma AC, Ren Y. Enamel reduction techniques in orthodontics: a literature review. Open Dent J. 2013 Oct 31;7:146-51. doi: 10.2174/1874210601307010146. eCollection 2013.
PubMed 24265652Boyd RL. Esthetic orthodontic treatment using the invisalign appliance for moderate to complex malocclusions. J Dent Educ. 2008 Aug;72(8):948-67.
PubMed 18676803Pindoria J, Fleming PS, Sharma PK. Inter-proximal enamel reduction in contemporary orthodontics. Br Dent J. 2016 Dec 16;221(12):757-763. doi: 10.1038/sj.bdj.2016.945.
PubMed 27982013Lombardo L, Guarneri MP, D'Amico P, Molinari C, Meddis V, Carlucci A, Siciliani G. Orthofile(R): a new approach for mechanical interproximal reduction : a scanning electron microscopic enamel evaluation. J Orofac Orthop. 2014 May;75(3):203-12. doi: 10.1007/s00056-014-0213-0. Epub 2014 May 15.
PubMed 24825832Joseph VP, Rossouw PE, Basson NJ. Orthodontic microabrasive reproximation. Am J Orthod Dentofacial Orthop. 1992 Oct;102(4):351-9. doi: 10.1016/0889-5406(92)70051-B.
PubMed 1333728Zachrisson BU. Actual damage to teeth and periodontal tissues with mesiodistal enamel reduction ("stripping"). World J Orthod. 2004 Summer;5(2):178-83. No abstract available.
PubMed 15615137Jarjoura K, Gagnon G, Nieberg L. Caries risk after interproximal enamel reduction. Am J Orthod Dentofacial Orthop. 2006 Jul;130(1):26-30. doi: 10.1016/j.ajodo.2004.08.024.
PubMed 16849068Lapenaite E, Lopatiene K. Interproximal enamel reduction as a part of orthodontic treatment. Stomatologija. 2014;16(1):19-24.
PubMed 24824056Marto CM, Baptista Paula A, Nunes T, Pimenta M, Abrantes AM, Pires AS, Laranjo M, Coelho A, Donato H, Botelho MF, Marques Ferreira M, Carrilho E. Evaluation of the efficacy of dentin hypersensitivity treatments-A systematic review and follow-up analysis. J Oral Rehabil. 2019 Oct;46(10):952-990. doi: 10.1111/joor.12842. Epub 2019 Jul 12.
PubMed 31216069
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dental and Periodontal Health After Interproximal Enamel Reduction, in Patients in Orthodontic Treatment With Clear Aligners, and Comparison Between Laser Diode and Sodium Fluoride for the Treatment of Dentin Hypersensitivity
- ClinicalTrials.gov ID
- NCT06685016
- Acronym / sponsor ID
- 0016945/i
- Conditions
- Dentinal Hypersensitivity, Plaque, Dental, Bleeding Gum
- Keywords
- Clear Aligners, Interproximal enamel reduction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 24 Jun 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Nov 2024 (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.
This study aimed to evaluate dental and periodontal health after interproximal enamel reduction and to compare Laser diode (a device used in the Orthodontic Program) and sodium fluoride (often used in the Orthodontic Program and in the Material Dental Program). The hypothesis was that the intervention groups would show a lower dentin hypersensitivity incidence than the control group during orthodontic treatment.
Detailed description
Interproximal enamel reduction (IPR) is a common procedure used during orthodontic treatment aimed to reduce mesio-distal tooth size dimensions to address lack of space (mild and moderate crowding), Bolton tooth-size discrepancy, correction of morphologic anomalies, tooth reshaping and management of gingival papilla. It is a practice that also offers an attractive alternative to overcome difficulty when extracting premolars and resolve the instability of overexpansion in non- extraction cases, improving the stability of the arches.
IPR may be exploited inconjunction with fixed appliance treatment, although its application with removable appliance treatment such as clear aligners is commonplace.
Clinically, the most accepted IPR techniques include air-rotor stripping with fine tungsten-carbide or diamond burs, handpiece or contra-angle-mounted diamond-coated disks, and handheld or motor- driven abrasive metal strips.
Some of these techniques can cause deep furrows and scratches that cannot be removed by polishing . In addition, these surface irregularities could promote the adherence of plaque bacteria and induce iatrogenic damage, such as dental caries, gingival inflammation, periodontal tissue breakdown, gingival recession and increased sensitivity of the shaped teeth to hot and cold temperatures.
Sometimes, after IPR, it is possible to have dentin hypersensitivity (DH), attributed to exposure to dentinal tubules. This clinical condition is influenced by various factors, including patient' s age, the severity of crowding, pathological tooth wear, hypersensitivity before treatment and the amount of the removed enamel.
DH can be defined as "short and sharp pain due to exposure of the dentinal tubules in response to thermal, evaporative, tactile, osmotic or chemical stimuli". The hydrodynamic theory proposed by Brännström is the most accepted theory to explain the DH mechanism. According to this theory, external stimuli, leading to fluid movement within the dentinal tubules and this movement indirectly stimulates the pulp nerve ends, causing a painful sensation.
Several methods can perform DH treatment. Based on the mode of their administration, the desensitizing treatment can be classified into at-home therapy or in-office therapy categories. At- home desensitizing products include toothpaste, mouthwashes and chewing gums. In contrast, in- office desensitizing products can be gels, solutions, varnishes, resin sealers, glass ionomers, dentin adhesives and more sophisticated laser techniques. In addition, eliminating of nociceptive stimuli, there are two main treatment strategies: modifying nervous response by preventing or reducing neuronal transmission and occluding the permeable dentinal tubules.
Potassium salts were thought to decrease the excitability of pulpal nerves and result in a reduction in DH. Still, clinical trials with sound design have failed to provide evidence that potassium is effective in desensitizing teeth. Potassium salts likely reduced the perception of dentin sensitivity through a placebo effect. The proposed mechanism for glutaraldehyde, another agent used for the treatment of DH, involves the reaction with serum albumin in dentinal tubule fluid, leading to precipitate formation within tubules and subsequent narrowing or blocking of the tubules. Strontium salts, fluoride, oxalate and arginine/calcium can occlude the tubules and form a protective layer on the dentin surface. Dental adhesives and resin sealants can occlude the dentinal tubules by forming a physical barrier thus blocking the movement of dentinal fluid and preventing direct stimulation of odontoblastic processes. The action of glass ionomers in the management of DH can also lead to occlusion of open dentinal tubules by precipitating a hydroxycarbonate apatite layer over the previously patent tubule openings. Laser treatment has been investigated as a prospective treatment for DH. Several studies suggest that the low-power laser could suppress the excitability of the pulpal nerves. Higher output laser is thought to reduce symptoms of DH by inducing the occlusion of dentin tubules.
Pain associated with DH may reduce the quality of life, but does not compromise people's health. Currently, no studies that have tested desensitizing substances to reduce or eliminate DH that can occur after IPR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Diagnostic Test: Evaluation of Dentin hypersensitivity with VAS scaleSubjects will not receive any treatment |
| Laser Diode Group | Experimental | Diagnostic Test: Evaluation of Dentin hypersensitivity with VAS scaleSubjects treated with Laser Diode |
| Sodium Fluoride Group | Experimental | Diagnostic Test: Evaluation of Dentin hypersensitivity with VAS scaleSubjects with a sodium fluoride gel treatment. |
Who may qualify
- Ages
- 17 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- to be in orthodontic treatment with clear aligners and this treatment requires interproximal enamel reduction;
- permanent dentition;
- good oral and periodontal health.
Key exclusion criteria (5 listed)
- enamel defects;
- cervical caries;
- periodontal disease;
- history of trauma or craniofacial anomalies;
- pregnancy.
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 |
|---|---|---|
| Evaluation of Dentin hypersensitivity with VAS scaleDentin hypersensitivity and periodontal indices evaluation are performed after and before IPR, at 1 week, 1 month and 3 months | Diagnostic test | Control Group, Laser Diode Group, Sodium Fluoride Group |
Primary outcome
Assestment of DH after IPR
Time frame: from 3 to 4 months
Dentin hypersensitivity will be assessed before and after interproximal enamel reduction and after the application of therapeutic protocols. Dentin hypersensitivity will be performed with the evaporative method. After isolation of the adjacent teeth, the air syringe will be placed 2-3 mm from the tooth surface, at a perpendicular position of 90º, and a continuous air blast of 45 to 60 psi (3.10 to 4.13 Bar) should be applied for 2-3 seconds. The air temperature should be around 20°C (19-22°C). The discomfort will be expressed in a numerical 0-10 cm visual analog scale (VAS) where the value 0 is correlated with no discomfort and the value 10 for utmost discomfort or intolerable pain during application of the stimulus. Each patient will place a vertical mark on the VAS to indicate the intensity of his or her level of sensitivity after the applied stimuli.
Reduction of the Dentin Hypersensitivity
Time frame: from 3 to 4 months
. Dentin hypersensitivity will be performed with the evaporative method. After isolation of the adjacent teeth, the air syringe will be placed 2-3 mm from the tooth surface, at a perpendicular position of 90º, and a continuous air blast of 45 to 60 psi (3.10 to 4.13 Bar) should be applied for 2-3 seconds. The air temperature should be around 20°C (19-22°C). The discomfort will be expressed in a numerical 0-10 cm visual analog scale (VAS) where the value 0 is correlated with no discomfort and the value 10 for utmost discomfort or intolerable pain during application of the stimulus. Each patient will place a vertical mark on the VAS to indicate the intensity of his or her level of sensitivity after the applied stimuli.
1 secondary outcome
Evaluation of Dentin hypersensitivity after the application of therapeutic protocols.
Time frame: from 3 to 4 months
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 14 Nov 2024.
- Background: PubMed 32762733Liu XX, Tenenbaum HC, Wilder RS, Quock R, Hewlett ER, Ren YF. Pathogenesis, diagnosis and management of dentin hypersensitivity: an evidence-based overview for dental practitioners. BMC Oral Health. 2020 Aug 6;20(1):220. doi: 10.1186/s12903-020-01199-z.
- Background: PubMed 16855970Poulsen S, Errboe M, Lescay Mevil Y, Glenny AM. Potassium containing toothpastes for dentine hypersensitivity. Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD001476. doi: 10.1002/14651858.CD001476.pub2.
- Background: PubMed 11203743Orchardson R, Gillam DG. The efficacy of potassium salts as agents for treating dentin hypersensitivity. J Orofac Pain. 2000 Winter;14(1):9-19.
- Background: PubMed 24265652Livas C, Jongsma AC, Ren Y. Enamel reduction techniques in orthodontics: a literature review. Open Dent J. 2013 Oct 31;7:146-51. doi: 10.2174/1874210601307010146. eCollection 2013.
- Background: PubMed 18676803Boyd RL. Esthetic orthodontic treatment using the invisalign appliance for moderate to complex malocclusions. J Dent Educ. 2008 Aug;72(8):948-67.
- Background: PubMed 27982013Pindoria J, Fleming PS, Sharma PK. Inter-proximal enamel reduction in contemporary orthodontics. Br Dent J. 2016 Dec 16;221(12):757-763. doi: 10.1038/sj.bdj.2016.945.
- Background: PubMed 24825832Lombardo L, Guarneri MP, D'Amico P, Molinari C, Meddis V, Carlucci A, Siciliani G. Orthofile(R): a new approach for mechanical interproximal reduction : a scanning electron microscopic enamel evaluation. J Orofac Orthop. 2014 May;75(3):203-12. doi: 10.1007/s00056-014-0213-0. Epub 2014 May 15.
- Background: PubMed 1333728Joseph VP, Rossouw PE, Basson NJ. Orthodontic microabrasive reproximation. Am J Orthod Dentofacial Orthop. 1992 Oct;102(4):351-9. doi: 10.1016/0889-5406(92)70051-B.
- Background: PubMed 15615137Zachrisson BU. Actual damage to teeth and periodontal tissues with mesiodistal enamel reduction ("stripping"). World J Orthod. 2004 Summer;5(2):178-83. No abstract available.
- Background: PubMed 16849068Jarjoura K, Gagnon G, Nieberg L. Caries risk after interproximal enamel reduction. Am J Orthod Dentofacial Orthop. 2006 Jul;130(1):26-30. doi: 10.1016/j.ajodo.2004.08.024.
- Background: PubMed 24824056Lapenaite E, Lopatiene K. Interproximal enamel reduction as a part of orthodontic treatment. Stomatologija. 2014;16(1):19-24.
- Background: PubMed 31216069Marto CM, Baptista Paula A, Nunes T, Pimenta M, Abrantes AM, Pires AS, Laranjo M, Coelho A, Donato H, Botelho MF, Marques Ferreira M, Carrilho E. Evaluation of the efficacy of dentin hypersensitivity treatments-A systematic review and follow-up analysis. J Oral Rehabil. 2019 Oct;46(10):952-990. doi: 10.1111/joor.12842. Epub 2019 Jul 12.
Related trials for Dentinal Hypersensitivity
RecruitingPhase 3
Comparative Efficacy of Different Dentin Occluding Toothpaste Technologies
Dentinal Sensitivity, Dentinal Hypersensitivity
Not yet recruitingPhase 2/3
Gluma Compared With Bonding Agent for Post-operative Sensitivity Following Composite Restorations
Post-operative Sensitivity, Dentin Hypersensitivity
Not yet recruiting
Comparative Efficacy of Laser Systems and Fluoride in Managing Dentinal Hypersensitivity: RCT
Dentin Sensitivity, Dentine Hypersensitivity, Tooth Sensitivity
Not yet recruiting
Comparison of LASER Therapy and Desensitizing Agents in Dentinal Hypersensitivity
Dentinal Hypersensitivity
Not yet recruiting
Potassium Nitrate Gel and Diode Laser in the Treatment of Dentinal Hypersensitivity
Dentistry, Desensitization
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.
Vincenzo Grassia, DDs,PhD principal investigator
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of Dentin hypersensitivity with VAS scale in people with Dentinal Hypersensitivity and Plaque, Dental, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 5 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: looking for participants now, as of the sponsor's last update on 14 Nov 2024. 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 Italy. 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?
Contact Vincenzo Grassia, DDs,PhD (+39 0815665524, vincenzo.grassia@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assestment of DH after IPR (time frame: from 3 to 4 months). The study lists 2 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 NCT06685016, which also lists 12 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 Nov 2024.