NCT07709286

Brief Summary

This clinical trial will be conducted to assess the clinical efficacy of using Antivet cleaning enamel solution or hydrochloric acid and phosphoric acid in microabrasion technique for mild to moderate intrinsic stained teeth.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
2mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress77%
Jan 2026Oct 2026

Study Start

First participant enrolled

January 10, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 10, 2026

Last Update Submit

July 14, 2026

Conditions

Keywords

tooth discolorationmicroabrasionantivet

Outcome Measures

Primary Outcomes (1)

  • Clinical performance

    visual analog scale using scoring system

    three months

Study Arms (3)

phosphoric acid 37% and aluminium oxid 50 microns

ACTIVE COMPARATOR

Microabrasion technique could be considered as the first treatment option when trying to improve the esthetics of teeth that present with mild or moderate intrinsic stains as it is a simple, safe, atraumatic, minimally invasive single visit procedure with high success rate

Drug: phosphoric acid 37% and aluminium oxid 50 microns

Opalustre™

ACTIVE COMPARATOR

a mixture of 37% phosphoric acid gel in extra fine grain pumice or 18% hydrochloric acid in pumice or 6.6% and 10% hydrochloric acid with silica carbide particles, with rubber cup in slow rotating motion to the areas of discoloration or white opacities. Another advantage of microabrasion technique is that it leaves the treated enamel surface as highly polished which minimizes the cariogenic bacteria colonization and render it more resistant to demineralization

Drug: Opalustre

Antivet

EXPERIMENTAL

The Antivet Kit solution is specially formulated to eliminate stains on the enamel surface caused by dental fluorosis or any other external factor.The tooth's surface is exposed to an acid solution by ionization by the fluoride absorbed in the apatite crystals (stains). This reaction allows for the fluoride ions to separate from the fluoride ions in the apatite crystals, forming soluble salts that are easily removed from the tooth enamel surface. Once the stains are removed, a calcium hydroxide solution is applied to neutralize the residual acidic solution left on the tooth surface. Lastly, the tooth is rinsed with water.Acid Base (Antivet): It is hydrofluoric acid at a 21% concentration stabilized by an organic tricarboxylic acid, with a controlled pH of \<3, necessary to react with the fluoride ions to form soluble salts. The organic and inorganic ions are extracted from within the fluorapatite crystals through this ionization process which essentially allows the enamel surface to be

Drug: (Antivet, MDC DENTAL, Zapopan Jalisco México)

Interventions

specially formulated to eliminate stains on the enamel surface caused by dental fluorosis or any other external factor.The tooth's surface is exposed to an acid solution by ionization by the fluoride absorbed in the apatite crystals (stains). This reaction allows for the fluoride ions to separate from the fluoride ions in the apatite crystals, forming soluble salts that are easily removed from the tooth enamel surface. Once the stains are removed, a calcium hydroxide solution is applied to neutralize the residual acidic solution left on the tooth surface. Lastly, the tooth is rinsed with water.Acid Base (Antivet): It is hydrofluoric acid at a 21% concentration stabilized by an organic tricarboxylic acid, with a controlled pH of \<3, necessary to react with the fluoride ions to form soluble salts. The organic and inorganic ions are extracted from within the fluorapatite crystals through this ionization process which essentially allows the enamel surface to be cleansed without damaging it

Antivet

technique involves employing a mixture 6.6% hydrochloric acid with silica carbide particles, with rubber cup in slow rotating motion to the areas of discoloration or white opacities for 60 seconds. The teeth will be rinsed with water between slurry applications. Depending on the stain reduction, microabrasion will be repeated up to six times during the same appointment to achieve the desired result. .

Opalustre™

● Equal quantities from phosphoric acid 37% and aluminium oxid 50 microns will be mixed, thick mix will be applied on the affected tooth/teeth and will be rubbed with a rubber cup in a low-speed contra-angle handpiece for 60 seconds of each application. Every patient will be received the entire microabrasion treatment in a single appointment with a maximum of 6 applications.

phosphoric acid 37% and aluminium oxid 50 microns

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with moderate to mild stained teeth.
  • years.
  • Males or Females.
  • Co-operative patients approving to participate in the study.

You may not qualify if:

  • High caries index with poor oral hygiene.
  • Severe medical complications.
  • Pregnancy.
  • Xerostomia.
  • Lack of compliance.
  • Smokers
  • Eligibility Criteria of teeth:
  • Anterior teeth.
  • Mild to moderate intrinsic or extrinsic stains.
  • Vital and non-sensitive anterior teeth.
  • pitted enamel.
  • carious teeth.
  • Deep lesions.
  • Severe periodontal problems.
  • Previous treatment for the stained teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egyptian Russian University

Badr, Cairo Governorate, 11829, Egypt

RECRUITING

Related Publications (1)

  • Blanchet I, Camoin A, Tardieu C, Jacquot B. Microabrasion in the management of enamel discolorations in paediatric dentistry: a systematic review. J Clin Pediatr Dent. 2023 Jan;47(1):17-26. doi: 10.22514/jocpd.2022.015. Epub 2023 Jan 3.

    PMID: 36627216BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration

Interventions

opalustrephosphoric acid

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Esraa Esmeail Hussien EEH Elhaddad, PHD

    Misr University for Science and Technology

    STUDY DIRECTOR

Central Study Contacts

Esraa Esmeail Hussien EEH Lecturer, phd holder

CONTACT

Dina Fayez Diab DFD Lecturer, phd holder

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The Antivet Kit solution is specially formulated to eliminate stains on the enamel surface caused by dental fluorosis or any other external factor.The tooth's surface is exposed to an acid solution by ionization by the fluoride absorbed in the apatite crystals (stains). This reaction allows for the fluoride ions to separate from the fluoride ions in the apatite crystals, forming soluble salts that are easily removed from the tooth enamel surface. Once the stains are removed, a calcium hydroxide solution is applied to neutralize the residual acidic solution left on the tooth surface. Lastly, the tooth is rinsed with water.Acid Base (Antivet): It is hydrofluoric acid at a 21% concentration stabilized by an organic tricarboxylic acid, with a controlled pH of \<3, necessary to react with the fluoride ions to form soluble salts. The organic and inorganic ions are extracted from within the fluorapatite crystals through this ionization process which essentially allows the enamel surface to be
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at Misr university for science and technology

Study Record Dates

First Submitted

July 10, 2026

First Posted

July 16, 2026

Study Start

January 10, 2026

Primary Completion

July 10, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

will not be shared except with authors only

Locations