NCT07355673

The Influence of Isolation Techniques in Gingival Irritation During an In-office Bleaching

A Double Blind Randomized Clinical Trial Comparing the Risk of Gingival Irritation of Two Different Isolation Techniques Performed During In-Office Bleaching

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Santiago de Compostela · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to evaluate if two different isolation techniques used during in-office bleaching influence the risk of gingival irritation. The secondary objectives were to investigate whether the isolation technique affects bleaching efficacy, the occurrence of tooth sensitivity, and the intensity of tooth sensitivity (TS).

Detailed description

1. Visit 1: Study information and delivery of informed consent. Recording of patient's medical history, general examination, and prophylaxis. Alginate impressions will be taken of the upper and lower arches for all the patients who meet the inclusion criteria. The impressions will be poured into plaster, and a positioning guide-finder tray will be fabricated for each patient for color measurement. 2. Visit 2: Initial color measurement with a spectrophotometer and the positioning guide. Two clinicians performed the assigned isolation technique (relative or absolute). Then after a correct isolation the clinicians apply over the buccal surface from premolar to premolar of both arches the bleaching agent (Opalescence Boost 40%, Ultradent Products, South Jordan, USA).Two application of 20 minutes each. Objective examination of gingival tissues was performed visually, documented with photographs, and verified using a periodontal probe. The sensitivity was recorded and patient were given a sensitivity test to record at home. c) Visit 3: One week after the first bleaching session. Color measurement with a spectrophotometer and the positioning guide. In this visit the second bleaching session was done with the same steps as visit 2. d) Visit 4: 15 days after the second bleaching session. Final data collection (color + patients sensitivity test)

Conditions

• Gingival Irritation

Interventions

Type	Name	Description
DEVICE	Relative Isolation	General Examination with bite-wings, dental prophylaxis, alginate impressions of both arches, creation of individualized bleaching trays and position finder trays. . Relative isolation of the gingival tissues. Two applications of the bleaching agent of 20 minutes
DEVICE	Absolute Isolation	General Examination with bite-wings, dental prophylaxis, alginate impressions of both arches, creation of individualized bleaching trays and position finder trays. . Absolute isolation of the gingival tissues. Two applications of the bleaching agent of 20 minutes

Timeline

• Start date: 2025-05-15
• Primary completion: 2025-07-16
• Completion: 2025-07-16
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: Spain