This randomized, split-mouth clinical trial will evaluate a new orthodontic adhesive that eliminates the need for acid etching before bracket bonding. Conventional orthodontic bonding requires etching enamel with phosphoric acid, which can weaken the outer enamel layer and increase the risk of white spot lesions and enamel damage. The etch-free adhesive under investigation is designed to simplify the bonding procedure while preserving enamel integrity.
Twenty orthodontic patients starting treatment with braces will participate. For each patient, one side of the mouth (left or right) will be randomly assigned to receive the etch-free adhesive, while the opposite side will receive the conventional adhesive with acid etching. This intra-patient design allows a direct comparison under identical oral conditions.
Participants will be followed for 12 months. Bracket failures, bonding time, ease of adhesive removal, enamel surface condition after debonding, and the presence of white spot lesions will be recorded. If effective, the etch-free adhesive may reduce enamel damage without compromising bond strength, providing a safer and more efficient bonding option for orthodontic patients.
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Crossover
Etch-Free Adhesive
DeviceA self-adhesive orthodontic bonding material applied directly to enamel without prior phosphoric acid etching or primer application. Brackets are bonded following the manufacturer's instructions.
Conventional Etch-and-Bond Adhesive
DeviceA standard orthodontic bonding protocol using 35-37% phosphoric acid etching, primer application, and a conventional light-cure adhesive. Brackets are bonded following the manufacturer's recommended procedure.
Bracket Failure Rate
The proportion of brackets bonded with each adhesive (etch-free vs. conventional) that experience bond failure over a 12-month follow-up period. A bond failure is defined as a clinically detached bracket requiring rebonding.
Bonding Time Per Quadrant
The time required to bond all brackets in one quadrant using either adhesive, measured in minutes using a digital timer.
Adhesive Remnant Index (ARI) at Debonding
The amount of adhesive remaining on the tooth surface after bracket removal, scored using the standardized Adhesive Remnant Index (0-3 scale).
Enamel Surface Integrity
Visual assessment of enamel for cracks, roughness, or damage after bracket removal, evaluated through clinical inspection and standardized digital photographs.
White Spot Lesion (WSL) Formation
Incidence and severity of new white spot lesions on bonded teeth, assessed using a standardized WSL index at 6 and 12 months.
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