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

Clinical Evaluation of Different Concentrations of Hydrochloric Acid Based as Micro Abrasive Kits in Management of Patients With Mild to Moderate Fluorosis (A 6month Randomized Clinical Trial)

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 .

Study Overview

• Status: Not yet recruiting
• Conditions: Fluorosis, Dental; Enamel Discoloration
• Intervention / Treatment: Drug: Antivet; Drug: opalustre

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yaqeen A Abdel-Razeq, Master's candidate; Phone Number: 0201121159913 0020201018769392; Email: yaqeen.atef@dentistry.cu.edu.eg
• Study Contact Backup: Name: Rawda H AbdElAziz, Lecturer; Phone Number: 0020201001097200; Email: rawda.hesham@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 : T( Time ) T0(base line )=Immediately , T1 = 3 Months , T2 = 6 Month
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 : T( Time ) T0(base line )=Immediately , T1 = 3 Months , T2 = 6 Month

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: April 28, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Randomized clinical trial; Patient Reported Outcome Measures; Dental fluorosis; Microabrasion; Enamel Discoloration; High consentration hydrochloric acid based microabrasive kit(Antivet); Low consentration hydrochloric acid based microabrasive kit ( opalustre)
• Additional Relevant MeSH Terms: Dental Enamel Hypomineralization; Developmental Defects of Enamel; Stomatognathic Diseases; Tooth Diseases; Chemically-Induced Disorders; Stomatognathic System Abnormalities; Congenital Abnormalities; Poisoning; Tooth Abnormalities; Fluorosis, Dental; Fluoride Poisoning
• Other Study ID Numbers: Opertive 4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No