Clinical Trial of New Etch-Free Orthodontic Adhesive's Bond Failure Rate
This study looks at the failure rate of a new etch-free orthodontic adhesive, comparing it to traditional adhesives. By tracking how many brackets become detached over a year, we can see if the new adhesive is as effective in keeping brackets in place.
Etch-Free Adhesive
+ Conventional Etch-and-Bond Adhesive
Treatment Study
Summary
Study start date: November 5, 2025
Actual date on which the first participant was enrolled.This clinical trial focuses on evaluating a new type of orthodontic adhesive that doesn't require the traditional acid etching process. Typically, acid etching is used to help adhesives stick to teeth, but it can damage tooth enamel and make teeth more prone to developing white spots. The new adhesive aims to bond directly to the tooth surface without this step, potentially preserving the enamel and making the application process quicker and more comfortable for patients. The study involves 20 patients, aged 12 and older, who are receiving fixed orthodontic treatment, and it seeks to determine if this new method can maintain strong dental bonds without the drawbacks of enamel damage. In this study, each participant will have both the traditional and the new etch-free adhesive applied to different sides of their mouth, allowing direct comparison under the same oral conditions. The bonding process involves applying the traditional adhesive after etching the teeth with phosphoric acid on one side, while the new adhesive is applied directly on the other side. The primary focus is on the rate at which brackets fail or fall off, and this will be checked monthly. Other aspects being measured include the time taken to bond each bracket, the condition of the enamel after the brackets are removed, and any discomfort reported by patients. The study ensures participants' safety and confidentiality, with the trial being reviewed for minimal risk and allowing participants to withdraw anytime without affecting their treatment.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 14 to 35 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: Patients aged 14 to 35 years Requiring comprehensive fixed orthodontic treatment with brackets on both arches Good general health with no contraindications to orthodontic treatment Presence of at least 10 permanent teeth per arch suitable for bracket bonding Ability and willingness to comply with study visits and follow-up for at least 12 months Parent/guardian consent and child assent obtained as appropriate Exclusion Criteria: Presence of systemic diseases or conditions that affect oral health or healing (e.g., uncontrolled diabetes, immunosuppression) Teeth with significant enamel defects, restorations, or caries in bonding areas Patients currently undergoing or who have undergone orthodontic treatment previously History of allergy or sensitivity to dental adhesives or related materials Patients with poor oral hygiene or active periodontal disease Use of medications known to affect tooth enamel or oral tissues (e.g., long-term corticosteroids) Inability to attend follow-up visits or anticipated lack of compliance Participation in another clinical trial that could interfere with study outcomes
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location