Hypomineralization of EnamelNCT05900817
Esthetic Management of Anterior Teeth Utilizing Two Micro Abrasion Treatments
A study testing antivet and Oplsture in people with Hypomineralization of Enamel, run by Beni-Suef University at 1 site in Egypt.
Trial summary
the aim of this clinical trial is to compare the new micro-abrasion material "ANTIVET" compared to the conventional micro-abrasion material used widely "opalustre". to achieve better esthetics in cases of hypo-mineralized anterior permanent teeth of children and young adults. Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypomineralization of Enamel
- What is being tested?
- antivet and Oplsture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Nov 2022
- 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 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- participants having anterior teeth
- with Degree 1 (mild) according to the Wetzel and Reckel scale.: Isolated white and cream to yellowish brown discolorations on the chewing surface and upper part of the crown , for
- caries-free teeth.
Who cannot join
- were children with :
- generalized hypoplasia
- amelogenesis imperfecta
- dentinogenesis imperfecta
- tetracycline or diffuse hypoplasia like fluorosis
- grossly broken and missing teeth where the reason of MIH could not be established.
- children with special health care needs.
- fractured, carious, grossly decayed teeth. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Esthetic Management of Anterior Teeth Utilizing Two Micro Abrasion Treatments: Randomized Clinical Trial
the aim of this clinical trial is to compare the new micro-abrasion material "ANTIVET" compared to the conventional micro-abrasion material used widely "opalustre". to achieve better esthetics in cases of hypo-mineralized anterior permanent teeth of children and young adults.
both materials will be applied by the researchers and patient's teeth sensitivity and color change will be assessed immediately , after one month and after three months
Read the detailed description
Materials and methods:
Enamel Microabrasion Even though only maxillary and mandibular hypominerlized incisors and canines were included in the current study, all teeth visible during smiling, laughing, or speaking were treated in this trial. The teeth were cleaned with pumice before treatment. Initial photographs of the teeth were taken.
Opalustre:
They were isolated with a rubber dam and then a fine-grit, water-cooled diamond bur was applied to the stained and white opaque enamel region for five to 10 seconds to enable penetration of the gel into the enamel. An approximately 1-mm- thick layer of 6.6% hydrochloric acid slurry with silicone carbide microparticles (Opalustre, Ultradent Products Inc, South Jordan, UT, USA) was applied to the affected tooth surfaces.
Antivet :
Teeth treated will be isolated first then Vaseline will be placed on gingival sulcus before placing dental dam., patient will be seated at a 45 degree angle. Five drops of Antivet in the plastic mixing well that comes. Then ANTIVET solution will be applied over the tooth's surface using a well condensed cotton pellet (approximately a 3 mm diameter). When the cotton pellet is pigmented by the tooth's staining, it will be changed for a new one. This process may take about 1 to 5 minutes per tooth, It should take no longer than 15 minutes from the moment the solution contacts the tooth's surface
Materials Treatment 1 opalustre Ultra dent Treatment 2 Antivet MDC
Sampling:
Thirty participants, aged between 9-18yrs, with dental hypo mineralized discolored anterior teeth and who met the following inclusion and exclusion criteria will be selected for the study.
Recruitment:
The two principal investigators and operators screened patients in Outpatient clinics of departments of Pediatric Dentistry and Public Health in Faculty of Dentistry - Beni-suef University \& Restorative Dentistry- Faculty of Dentistry in the British University in Egypt irrespectively. The screening process was continued until the target population was achieved.
Patients will be randomly allocated in both treatment groups
Blinding:
Participants, outcome assessors and data analyst will be blinded to the interventions during the clinical trial. After complete data entry of the trial, they will be unblinded to avoid any bias to either two groups.
Outcome assessor chart was examined and filled up by two experts. Both investigators won't be involved in assessing the outcome. Informed Consent: both Investigators will be introduced the trial to patients regarding the main aspects of the trial.
A written informed consent forms (Arabic and English versions) were signed by all patients participated in the trial. The protocol, informed consent forms, participant education and recruitment materials will be reviewed and approved by the Ethical Committee of Faculty of Oral and Dental Medicine- Beni-Suef University.
outcomes will be assessed immediately after the procedure, 1 month and 3 months Pre-operative and post operative photographs will be taken to document color improvement in each visit
- Conditions
- Hypomineralization of Enamel
- Being tested
- antivet, Oplsture
- Medical subject headings
- Dental Enamel Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antivetOther
A material used for micro abrasion of teeth
OplstureOther
A material used for micro abrasion of teeth
| Study group | Role | What they receive |
|---|---|---|
| antivet arm | Experimental | Teeth treated will be isolated first then Vaseline will be placed on gingival sulcus before placing dental dam., patient will be seated at a 45 degree angle. Five drops of Antivet in the plastic mixing well that comes. Then ANTIVET solution will be applied over the tooth's surface using a well condensed cotton pellet (approximately a 3 mm diameter). When the cotton pellet is pigmented by the tooth's staining, it will be changed for a new one. This process may take about 1 to 5 minutes per tooth, It should take no longer than 15 minutes from the moment the solution contacts the tooth's surface Receives: Other: antivet |
| opulsture arm | Active comparator | They were isolated with a rubber dam and then a fine-grit, water-cooled diamond bur was applied to the stained and white opaque enamel region for five to 10 seconds to enable penetration of the gel into the enamel. An approximately 1-mm- thick layer of 6.6% hydrochloric acid slurry with silicone carbide microparticles (Opalustre, Ultradent Products Inc, South Jordan, UT, USA) was applied to the affected tooth surfaces. Receives: Other: Oplsture |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative changes in teeth sensitivity
visual analogue scale (0:no pain,10:worst pain) - verbal analogue scale (no pain or distressing, miserable pain )
Measured: change from baseline teeth sensitivity immediately after treatment ,change from baseline teeth sensitivity after one month from treatment and change from baseline teeth sensitivity after three month from treatment after
patient satisfaction
using a 5- point Likert scale ( 1= not at all satisfied, 5= extremely satisfied) likert scale: where 1 represents no improvement at all and 7 represents excellent improvement.
photography conditions will be standardized during pre and post treatment photos
Measured: after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start1 Aug 2022
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
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 Hypomineralization of EnamelStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Mohamed Shafik Khalil, Beni-Suef University
- Investigators
- Sarah MS khalil, phD, Principal investigator, lecturer of Pediatric Dentistry ,Faculty of Dentistry ,Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900817
- Sponsor's protocol ID
- #REC-FDBSU/06102020-01/SS
- Status last verified
- Jun 2023
- First submitted
- 16 Nov 2022
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all Data will be available within 3 months
Publications
Denis M, Atlan A, Vennat E, Tirlet G, Attal JP. White defects on enamel: diagnosis and anatomopathology: two essential factors for proper treatment (part 1). Int Orthod. 2013 Jun;11(2):139-65. doi: 10.1016/j.ortho.2013.02.014. Epub 2013 Apr 16. English, French.
PubMed 23597715Torres CR, Borges AB. Color masking of developmental enamel defects: a case series. Oper Dent. 2015 Jan-Feb;40(1):25-33. doi: 10.2341/13-346-T. Epub 2014 Aug 19.
PubMed 25136905Akin M, Basciftci FA. Can white spot lesions be treated effectively? Angle Orthod. 2012 Sep;82(5):770-5. doi: 10.2319/090711.578.1. Epub 2012 Feb 23.
PubMed 22356705Huang GJ, Roloff-Chiang B, Mills BE, Shalchi S, Spiekerman C, Korpak AM, Starrett JL, Greenlee GM, Drangsholt RJ, Matunas JC. Effectiveness of MI Paste Plus and PreviDent fluoride varnish for treatment of white spot lesions: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2013 Jan;143(1):31-41. doi: 10.1016/j.ajodo.2012.09.007.
PubMed 23273358Pini NI, Sundfeld-Neto D, Aguiar FH, Sundfeld RH, Martins LR, Lovadino JR, Lima DA. Enamel microabrasion: An overview of clinical and scientific considerations. World J Clin Cases. 2015 Jan 16;3(1):34-41. doi: 10.12998/wjcc.v3.i1.34.
PubMed 25610848Deshpande AN, Joshi NH, Pradhan NR, Raol RY. Microabrasion-remineralization (MAb-Re): An innovative approach for dental fluorosis. J Indian Soc Pedod Prev Dent. 2017 Oct-Dec;35(4):384-387. doi: 10.4103/JISPPD.JISPPD_216_16.
PubMed 28914255Donly KJ, O'Neill M, Croll TP. Enamel microabrasion: a microscopic evaluation of the "abrosion effect". Quintessence Int. 1992 Mar;23(3):175-9.
PubMed 1641458
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic Management of Anterior Teeth Utilizing Two Micro Abrasion Treatments: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05900817
- Acronym / sponsor ID
- #REC-FDBSU/06102020-01/SS
- Conditions
- Hypomineralization of Enamel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 13 Jun 2023 (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 aim of this clinical trial is to compare the new micro-abrasion material "ANTIVET" compared to the conventional micro-abrasion material used widely "opalustre". to achieve better esthetics in cases of hypo-mineralized anterior permanent teeth of children and young adults.
both materials will be applied by the researchers and patient's teeth sensitivity and color change will be assessed immediately , after one month and after three months
Detailed description
Materials and methods:
Enamel Microabrasion Even though only maxillary and mandibular hypominerlized incisors and canines were included in the current study, all teeth visible during smiling, laughing, or speaking were treated in this trial. The teeth were cleaned with pumice before treatment. Initial photographs of the teeth were taken.
Opalustre:
They were isolated with a rubber dam and then a fine-grit, water-cooled diamond bur was applied to the stained and white opaque enamel region for five to 10 seconds to enable penetration of the gel into the enamel. An approximately 1-mm- thick layer of 6.6% hydrochloric acid slurry with silicone carbide microparticles (Opalustre, Ultradent Products Inc, South Jordan, UT, USA) was applied to the affected tooth surfaces.
Antivet :
Teeth treated will be isolated first then Vaseline will be placed on gingival sulcus before placing dental dam., patient will be seated at a 45 degree angle. Five drops of Antivet in the plastic mixing well that comes. Then ANTIVET solution will be applied over the tooth's surface using a well condensed cotton pellet (approximately a 3 mm diameter). When the cotton pellet is pigmented by the tooth's staining, it will be changed for a new one. This process may take about 1 to 5 minutes per tooth, It should take no longer than 15 minutes from the moment the solution contacts the tooth's surface
Materials Treatment 1 opalustre Ultra dent Treatment 2 Antivet MDC
Sampling:
Thirty participants, aged between 9-18yrs, with dental hypo mineralized discolored anterior teeth and who met the following inclusion and exclusion criteria will be selected for the study.
Recruitment:
The two principal investigators and operators screened patients in Outpatient clinics of departments of Pediatric Dentistry and Public Health in Faculty of Dentistry - Beni-suef University \& Restorative Dentistry- Faculty of Dentistry in the British University in Egypt irrespectively. The screening process was continued until the target population was achieved.
Patients will be randomly allocated in both treatment groups
Blinding:
Participants, outcome assessors and data analyst will be blinded to the interventions during the clinical trial. After complete data entry of the trial, they will be unblinded to avoid any bias to either two groups.
Outcome assessor chart was examined and filled up by two experts. Both investigators won't be involved in assessing the outcome. Informed Consent: both Investigators will be introduced the trial to patients regarding the main aspects of the trial.
A written informed consent forms (Arabic and English versions) were signed by all patients participated in the trial. The protocol, informed consent forms, participant education and recruitment materials will be reviewed and approved by the Ethical Committee of Faculty of Oral and Dental Medicine- Beni-Suef University.
outcomes will be assessed immediately after the procedure, 1 month and 3 months Pre-operative and post operative photographs will be taken to document color improvement in each visit
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antivet arm | Experimental | Other: antivetTeeth treated will be isolated first then Vaseline will be placed on gingival sulcus before placing dental dam., patient will be seated at a 45 degree angle. Five drops of Antivet in the plastic mixing well that comes. Then ANTIVET solution will be applied over the tooth's surface using a well condensed cotton pellet (approximately a 3 mm diameter). When the cotton pellet is pigmented by the tooth's staining, it will be changed for a new one. This process may take about 1 to 5 minutes per tooth, It should take no longer than 15 minutes from the moment the solution contacts the tooth's surface |
| opulsture arm | Active comparator | Other: OplstureThey were isolated with a rubber dam and then a fine-grit, water-cooled diamond bur was applied to the stained and white opaque enamel region for five to 10 seconds to enable penetration of the gel into the enamel. An approximately 1-mm- thick layer of 6.6% hydrochloric acid slurry with silicone carbide microparticles (Opalustre, Ultradent Products Inc, South Jordan, UT, USA) was applied to the affected tooth surfaces. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- participants having anterior teeth
- with Degree 1 (mild) according to the Wetzel and Reckel scale.: Isolated white and cream to yellowish brown discolorations on the chewing surface and upper part of the crown , for
- caries-free teeth.
Key exclusion criteria (8 listed)
- generalized hypoplasia
- amelogenesis imperfecta
- dentinogenesis imperfecta
- tetracycline or diffuse hypoplasia like fluorosis
- grossly broken and missing teeth where the reason of MIH could not be established.
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 |
|---|---|---|
| antivetA material used for micro abrasion of teeth | Other | antivet arm |
| OplstureA material used for micro abrasion of teeth | Other | opulsture arm |
Primary outcome
postoperative changes in teeth sensitivity
Time frame: change from baseline teeth sensitivity immediately after treatment ,change from baseline teeth sensitivity after one month from treatment and change from baseline teeth sensitivity after three month from treatment after
visual analogue scale (0:no pain,10:worst pain) - verbal analogue scale (no pain or distressing, miserable pain )
patient satisfaction
Time frame: after 3 months
using a 5- point Likert scale ( 1= not at all satisfied, 5= extremely satisfied) likert scale: where 1 represents no improvement at all and 7 represents excellent improvement. photography conditions will be standardized during pre and post treatment photos
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 13 Jun 2023.
- Background: PubMed 23597715Denis M, Atlan A, Vennat E, Tirlet G, Attal JP. White defects on enamel: diagnosis and anatomopathology: two essential factors for proper treatment (part 1). Int Orthod. 2013 Jun;11(2):139-65. doi: 10.1016/j.ortho.2013.02.014. Epub 2013 Apr 16. English, French.
- Background: PubMed 25136905Torres CR, Borges AB. Color masking of developmental enamel defects: a case series. Oper Dent. 2015 Jan-Feb;40(1):25-33. doi: 10.2341/13-346-T. Epub 2014 Aug 19.
- Background: PubMed 22356705Akin M, Basciftci FA. Can white spot lesions be treated effectively? Angle Orthod. 2012 Sep;82(5):770-5. doi: 10.2319/090711.578.1. Epub 2012 Feb 23.
- Background: PubMed 23273358Huang GJ, Roloff-Chiang B, Mills BE, Shalchi S, Spiekerman C, Korpak AM, Starrett JL, Greenlee GM, Drangsholt RJ, Matunas JC. Effectiveness of MI Paste Plus and PreviDent fluoride varnish for treatment of white spot lesions: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2013 Jan;143(1):31-41. doi: 10.1016/j.ajodo.2012.09.007.
- Background: PubMed 25610848Pini NI, Sundfeld-Neto D, Aguiar FH, Sundfeld RH, Martins LR, Lovadino JR, Lima DA. Enamel microabrasion: An overview of clinical and scientific considerations. World J Clin Cases. 2015 Jan 16;3(1):34-41. doi: 10.12998/wjcc.v3.i1.34.
- Background: PubMed 28914255Deshpande AN, Joshi NH, Pradhan NR, Raol RY. Microabrasion-remineralization (MAb-Re): An innovative approach for dental fluorosis. J Indian Soc Pedod Prev Dent. 2017 Oct-Dec;35(4):384-387. doi: 10.4103/JISPPD.JISPPD_216_16.
- Background: PubMed 1641458Donly KJ, O'Neill M, Croll TP. Enamel microabrasion: a microscopic evaluation of the "abrosion effect". Quintessence Int. 1992 Mar;23(3):175-9.
- Individual participant dataSharing planned: No. all Data will be available within 3 months
Related trials for Hypomineralization of Enamel
Not yet recruiting
Esthetic Impact of Different Minimally Invasive Approaches on Hypomineralized Permanent Anterior Teeth
Enamel Hypomineralization, Dental
Active, not recruiting
Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment
Molar Incisor Hypomineralization
Not yet recruiting
Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
Molar-Incisor Hypomineralization (MIH)
Recruiting
Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
Fluoride Varnishes, Molar Incisor Hypomineralisation
Recruiting
Molar-Incisor Hypomineralization and Resin Infiltration
Molar Incisor Hypomineralization
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.
Sarah MS khalil, phD principal investigator
lecturer of Pediatric Dentistry ,Faculty of Dentistry ,Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antivet and Oplsture in people with Hypomineralization of Enamel, run by Beni-Suef University at 1 site in Egypt.
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 8 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 13 Jun 2023. 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 Egypt. 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?
postoperative changes in teeth sensitivity (time frame: change from baseline teeth sensitivity immediately after treatment ,change from baseline teeth sensitivity after one month from treatment and change from baseline teeth sensitivity after three month from treatment after). 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 NCT05900817, 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 13 Jun 2023.