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

NCT07355673 | Completed DMC

• 1 other identifier: 2025/02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Gingival Irritation

Keywords

Gingival irritation; Vital Bleaching; In-Office bleaching; Isolation

Outcome Measures

Primary Outcomes (1)

• Gingival Evaluation Recording

  Objective examination of gingival tissues was performed visually, documented with photographs, and verified using a periodontal probe. Patients were classified according to the Löe and Silness' gingival index as follows: G0 =normal gingiva; G1=mild inflammation (slight color change, slight edema, no bleeding on probing); G2=moderate inflammation (redness, edema, glazing, bleeding on probing); and G3=severe inflammation (marked redness and edema, ulceration, spontaneous bleeding).

  -15 minutes after the first bleaching session - 15 minutes after the second bleaching session

Secondary Outcomes (2)

• Questionary of dental sensitivity

  Perioperative , 1 hour postoperative, 24 hours postoperative, 48 hours postoperative.

• Shade evaluation of each patient

  Baseline, Before the first bleaching session, Revision (1 week after the 2 bleaching session)

Study Arms (2)

Relative Isolation

ACTIVE COMPARATOR

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.

Device: Relative Isolation

Absolute isolation

EXPERIMENTAL

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.

Device: Absolute Isolation

Interventions

Absolute Isolation DEVICE

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

Absolute isolation

Relative Isolation DEVICE

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

Relative Isolation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Sites (1)

School of Medicine and Dentistry

Santiago de Compostela, A Coruña, 15705, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, Double Blind, Clinical Trial

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 21, 2026
• Study Start: May 15, 2025
• Primary Completion: July 16, 2025
• Study Completion: July 16, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)