NCT05900817

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

November 16, 2022

Last Update Submit

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

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

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.

Other: Oplsture

Interventions

antivetOTHER

A material used for micro abrasion of teeth

antivet arm

A material used for micro abrasion of teeth

opulsture arm

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Location

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: 23597715BACKGROUND
  • Torres 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: 25136905BACKGROUND
  • Akin 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: 22356705BACKGROUND
  • Huang 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: 23273358BACKGROUND
  • Pini 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: 25610848BACKGROUND
  • Deshpande 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: 28914255BACKGROUND
  • Donly 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

Dental Enamel Hypomineralization

Condition Hierarchy (Ancestors)

Developmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Sarah MS khalil, phD

    lecturer of Pediatric Dentistry ,Faculty of Dentistry ,Beni-Suef University

    PRINCIPAL INVESTIGATOR

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

Locations