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Randomized clinical trial comparing different treatments for Dental Fluorosis

Effectiveness of different treatment protocols for Dental Fluorosis: a double-blind randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-825ymxq
Enrollment
Unknown
Registered
2023-08-10
Start date
2023-10-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluorosis, Dental

Interventions

This is a randomized, controlled, parallel, and double-blind clinical study. The study will be conducted in São João do Rio do Peixe, an endemic city for dental fluorosis located in the interior of th
Group II (GII) - the reverse order of treatment from GI, starting with home bleaching and concluding with a session of MAB1 (CC + MAB1)
Group III (GIII) - one session of enamel microabrasion with a 6% hydrochloric acid and silicon carbide-based stain remover (MAB2) followed by home bleaching (MAB2 + CC)
and Group IV (GIV) - the reverse order of treatment from GIII, starting with home bleaching and concluding with a session of MAB2 (CC + MAB2).
E06.420.750

Sponsors

Universidade Federal da Paraíba
Lead Sponsor
Universidade Federal da Paraíba
Collaborator

Eligibility

Age
15 Years to No maximum

Inclusion criteria

Inclusion criteria: Presenting a minimum of four anterior and/or superior teeth affected by dental fluorosis in the range of 1 to 6 according to the Thylstrup and Fejerskov Index; demonstrating good oral health condition (absence of active caries or periodontal disease in the anterior and/or superior and inferior teeth); being at least 15 years of age; having good general health condition (absence of cardiac problems, hypertension, or uncontrolled diabetes); showing an interest in improving the appearance of stained teeth

Exclusion criteria

Exclusion criteria: Presence of structural defects on the enamel surface; loss or fracture of any upper element; evidence of significant malocclusion; pregnant or lactating individuals; individuals undergoing orthodontic treatment; history of previous dentin sensitivity; restorations involving more than 1/6 of the vestibular face of any of the six anterior and/or inferior teeth; severity of fluorosis greater than 6 according to the Thylstrup and Fejerskov Index; history of prior treatment for dental fluorosis

Design outcomes

Primary

MeasureTime frame
Both enamel microabrasion protocols, using 37% phosphoric acid and pumice, and the pre-fabricated paste containing 6% hydrochloric acid and silicon carbide, are expected to demonstrate similar efficacy in reducing the area of dental fluorosis staining;It is expected that the sequence of enamel microabrasion, followed by home bleaching with 10% carbamide peroxide, will be more effective compared to the reverse treatment sequence in reducing the area of dental fluorosis staining

Secondary

MeasureTime frame
Significant differences in the efficacy of dental color alteration are expected depending on the sequence of enamel microabrasion application before or after home bleaching, using a spectrophotometer;Significant differences in absolute risk and intensity of dental sensitivity are expected depending on the sequence of enamel microabrasion application before or after home bleaching, using a visual analog scale;Significant differences in enamel mineral content are expected depending on the sequence of enamel microabrasion application before or after home bleaching, using the fluorescence method;Statistical differences in longevity are expected after three, six, twelve, and twenty-four months of treatments, depending on the sequence of enamel microabrasion application before or after home bleaching;Significant differences in the impact of oral health on quality of life before and after treatment are expected depending on the sequence of enamel microabrasion application before or after home bleaching, using the Oral Health Impact Profile-14 questionnaire (OHIP-14) and the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ)

Countries

Brazil

Contacts

Public ContactLaryssa Barbosa

Universidade Federal da Paraíba

laryssamylenna@hotmail.com+55-083-988809474

Outcome results

None listed

Source: REBEC (via WHO ICTRP)