Esthetic Management of Anterior Teeth Utilizing Two Micro Abrasion Treatments

Hypomineralization of Enamel Clinical Trial

Official title:

Esthetic Management of Anterior Teeth Utilizing Two Micro Abrasion Treatments: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05900817
• Other study ID #: #REC-FDBSU/06102020-01/SS
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: June 2023
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Hypomineralization of Enamel

Intervention

Other:
• antivet
A material used for micro abrasion of teeth
• Oplsture
A material used for micro abrasion of teeth

Locations

Country	Name	City	State
Egypt	Sarah Mohamed Shafik Khalil	Cairo	Nasr City

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

Donly KJ, O'Neill M, Croll TP. Enamel microabrasion: a microscopic evaluation of the "abrosion effect". Quintessence Int. 1992 Mar;23(3):175-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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