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Not yet recruitingNCT06949878Updated Apr 29, 2025

21% Hydrochloric Acid Based Versus 6.6 % Hydrochloric Based Micro Abrasive Kit in Management of Patients With Mild to Moderate Fluorosis

A Phase 4 interventional study of Antivet and opalustre in Enamel Discoloration and Fluorosis, Dental, sponsored by Cairo University. Not yet recruiting. Open to participants aged 15 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-04-29.

Sponsored by Cairo University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
15 Years to 45 Years
Sex
All
01

Study summary

compare the clinical performance of different concentrations of hydrochloric acid based as micro abrasive kits in management of patients with mild to moderate fluorosis over 6month follow up .

Read the detailed description

microabrasion is a permanent cosmetic dentistry treatment indeed to preserve the health of all part of any defect in enamel.

02

Conditions studied

  • Enamel Discoloration
  • Fluorosis, Dental

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Keywords

  • Dental fluorosis
  • Microabrasion
  • Enamel Discoloration
  • Patient Reported Outcome Measures
  • Randomized clinical trial
  • High consentration hydrochloric acid based microabrasive kit(Antivet)
  • Low consentration hydrochloric acid based microabrasive kit ( opalustre)
03

Who can participate

Ages eligible
15 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients who wanted to change the appearance of their stained teeth Males or females. Patients with three or more stained incisors and canines Patients willing and able to attend periodic follow-up visits Patient concerning with oral health. Co-operative patients who show interest to participate in the study.

Exclusion criteria

Exclusion Criteria:

Patients with known allergic or adverse reaction to the tested materials. Smoking habit Patients having Poor oral hygiene Patients with special health care needs or any systemic disease that may affect treatment Patients participating in other dental studies. Patients suffering from white spot lesion, hypoplasia, amelogenesis imperfecta, dentinogenesis imperfecta, or badly broken and missing teeth due to MIH.

Participants who had a history of dental bleaching.

04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Antivet

    Complete stain removal from the Enamel Use a compact cotton swab (3 mm) to apply Antivet solution (Dental Continental, México)to the stained dental piece according to manufacturer's instructions. Replace the swab as it becomes stained and continue until the stain is removed. " This may take 1-5 minutes per tooth, but do not exceed 15 minutes in total. " We will keep the tooth moist during the process for effective results and avoid reusing stained cotton swab. Then we will apply the neutralizing solution to the tooth with a brush or micro brush, ensuring it reaches the gingival margin. Leave it on for 2 minutes. Once the antivet solution is neutralized, rinse the area and remove the rubber dam.

    Drug: Antivet

  • Experimental
    :opalustre

    Complete stain removal from the Enamel. Product will be applied to the surface with a 1 mm thick layer; ten applications of 60s to help penetration of the gel into the enamel. Using an abrasive rubber cup (OpalCup™ Ultradent) in contra-angle low-speed handpiece at low revolution. Then will be rinsed with injectable water for 30 seconds between each application

    Drug: opalustre

Interventions

  • DrugAntivet

    Complete stain removal from the Enamel-Use a compact cotton swab (3 mm) to apply Antivet solution (Dental Continental, México)to the stained dental piece according to manufacturer's instructions.-Replace the swab as it becomes stained and continue until the stain is removed. " This may take 1-5 minutes per tooth, but do not exceed 15 minutes in total. " - We will keep the tooth moist during the process for effective results and avoid reusing stained cotton swab.-Then we will apply the neutralizing solution to the tooth with a brush or micro brush, ensuring it reaches the gingival margin. Leave it on for 2 minutes.-Once the antivet solution is neutralized, rinse the area and remove the rubber dam.

  • Drugopalustre

    Complete stain removal from the Enamel. Product will be applied to the surface with a 1 mm thick layer; ten applications of 60s to help penetration of the gel into the enamel.- Using an abrasive rubber cup (OpalCup™ Ultradent) in contra-angle low-speed handpiece at low revolution.- Then will be rinsed with injectable water for 30 seconds between each application.

05

What researchers measure

Primary outcomes

  1. Clinical assessment of treatment success

    Enamel discoloration or texture by Spectrophotometer Vita EasyShade When totally removed of fluorotic white spots = success \& when stains doesn't removed and surface irregular = failure

    Time frame: T( Time ) T0(base line )=Immediately , T1 = 3 Months , T2 = 6 Month

Secondary outcomes

  1. Clinical evaluation of Sensitivity

    Patient reported outcome measures by visual analog scale (VAS) Is used to describe sensitivity by patient themselves in scores as ( o : no sensitivity) ( 10 : highly sensitive )

    Time frame: Time frame : T( Time ) T0(base line )=Immediately , T1 = 3 Months , T2 = 6 Month

  2. Patient satisfaction with the Treatment.

    Patient reported outcome measures by 4-point Likert scale used to describe patient satisfaction with treatment as \[(a) "yes, very satisfied", (b) "yes, mostly satisfied", (c) "less satisfied", (d) "not at all satisfied"\].

    Time frame: Time frame : T( Time ) T0(base line )=Immediately , T1 = 3 Months , T2 = 6 Month

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06949878
Lead sponsor
Cairo University
Responsible party
Yaqeen Atef AbdelRazeq Mohammed (Dentist, Cairo University) — Principal investigator
First posted
Apr 29, 2025
Start date
May 2025 (estimated)
Primary completion
Jun 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Apr 29, 2025

Study contacts

Yaqeen A Abdel-Razeq, Master's candidate
Contact
yaqeen.atef@dentistry.cu.edu.eg
0020201018769392 ext. 0201121159913
Rawda H AbdElAziz, Lecturer
Contact
rawda.hesham@dentistry.cu.edu.eg
0020201001097200

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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