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

University of Santiago de Compostela

Status: Completed

Conditions: Gingival Irritation

Treatments: Device: Absolute Isolation; Device: Relative Isolation

Study type: Interventional

Funder types: Other

Identifiers

NCT07355673

2025/02

Details and patient eligibility

About

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).

Full 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)

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No oral os systemic pathology
• Periodontally Healthy
• No cavities
• Tooth shade of the canines A2 or darker

Exclusion criteria

• Adhesive restorations or protheses in the anterior region
• Enamel or dentin alterations
• Smoking habits
• Pregnant women
• Undergone prior bleaching treatment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Relative Isolation

Active Comparator group

Description:

The relative isolation technique consists in inserting a lip retractor (OptraGate, Ivoclar Vivadent) and applying a gingival barrier resin (OpalDam, Ultradent Products) along the gingival margin, extending approximately 2-3 mm onto the enamel.

Treatment:

Device: Relative Isolation

Absolute isolation

Experimental group

Description:

The total rubber dam isolation was carried out placing the dam (Flexidam non latex; Roeko) from premolar to premolar in both arches and stabilizing it with clamps (B4; Hygenic). Dental silk ligatures were used to achieve proper cervical retraction.

Treatment:

Device: Absolute Isolation