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

NCT06949878 | Not Yet Recruiting Phase 4

• 1 other identifier: Opertive 4
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief 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 .

Conditions

Enamel Discoloration; Fluorosis, Dental

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)

Outcome Measures

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

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

Secondary Outcomes (2)

• Clinical evaluation of Sensitivity

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

• Patient satisfaction with the Treatment.

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

Study Arms (2)

Antivet

EXPERIMENTAL

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

:opalustre

EXPERIMENTAL

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

Antivet DRUG

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.

Antivet

opalustre DRUG

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.

:opalustre

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Fluorosis, Dental

Interventions

opalustre

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Yaqeen A Abdel-Razeq, Master's candidate

CONTACT

0020201018769392; yaqeen.atef@dentistry.cu.edu.eg

Rawda H AbdElAziz, Lecturer

CONTACT

0020201001097200; rawda.hesham@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share