Clinical trial NCT05900817: Esthetic Management of Anterior Teeth Utilizing Two Micro Abrasion Treatments
Official title: Esthetic Management of Anterior Teeth Utilizing Two Micro Abrasion Treatments: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypomineralization of Enamel
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: Inclusion Criteria:

participants having anterior teeth

1. 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
2. caries-free teeth.

Exclusion Criteria:

were children with :

1. generalized hypoplasia
2. amelogenesis imperfecta
3. dentinogenesis imperfecta
4. tetracycline or diffuse hypoplasia like fluorosis
5. grossly broken and missing teeth where the reason of MIH could not be established.
6. children with special health care needs.
7. fractured, carious, grossly decayed teeth. -

Primary outcomes:
measure: postoperative changes in teeth sensitivity
timeFrame: 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
measure: patient satisfaction
timeFrame: after 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sarah Mohamed Shafik Khalil
state: Nasr City
Study officials:
affiliation: lecturer of Pediatric Dentistry ,Faculty of Dentistry ,Beni-Suef University
name: Sarah MS khalil, phD
role: PRINCIPAL_INVESTIGATOR
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