Esthetic Management of Anterior Teeth Utilizing Two Micro Abrasion Treatments
1 other identifier
interventional
30
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 16, 2022
CompletedFirst Posted
Study publicly available on registry
June 13, 2023
CompletedJune 13, 2023
June 1, 2023
2 months
November 16, 2022
June 9, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
postoperative changes in teeth sensitivity
visual analogue scale (0:no pain,10:worst pain) - verbal analogue scale (no pain or distressing, miserable pain )
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
after 3 months
Study Arms (2)
antivet arm
EXPERIMENTALTeeth 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 COMPARATORThey 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sarah Mohamed Shafik Khalil
Cairo, Nasr City, 11765, Egypt
Related Publications (7)
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.
PMID: 23597715BACKGROUNDTorres 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.
PMID: 25136905BACKGROUNDAkin 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.
PMID: 22356705BACKGROUNDHuang 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.
PMID: 23273358BACKGROUNDPini 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.
PMID: 25610848BACKGROUNDDeshpande 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.
PMID: 28914255BACKGROUNDDonly KJ, O'Neill M, Croll TP. Enamel microabrasion: a microscopic evaluation of the "abrosion effect". Quintessence Int. 1992 Mar;23(3):175-9.
PMID: 1641458BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah MS khalil, phD
lecturer of Pediatric Dentistry ,Faculty of Dentistry ,Beni-Suef University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- 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. Two principal Investigators and operators) will be blinded until generation of the allocation sequence. Later on, two invistigators will be unblinded within the treatment session due to different treatments packing and steps. 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of Pediatric Dentistry and Dental public health
Study Record Dates
First Submitted
November 16, 2022
First Posted
June 13, 2023
Study Start
August 1, 2022
Primary Completion
October 1, 2022
Study Completion
November 1, 2022
Last Updated
June 13, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share
all Data will be available within 3 months