Gingival IrritationNCT07355673
The Influence of Isolation Techniques in Gingival Irritation During an In-office Bleaching
A study testing Relative Isolation and Absolute Isolation in people with Gingival Irritation, run by University of Santiago de Compostela at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Irritation
- What is being tested?
- Relative Isolation and Absolute Isolation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2025to 16 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No oral os systemic pathology
- Periodontally Healthy
- No cavities
- Tooth shade of the canines A2 or darker
Who cannot join
- Adhesive restorations or protheses in the anterior region
- Enamel or dentin alterations
- Smoking habits
- Pregnant women
- Undergone prior bleaching treatment
Trial locations and contacts
1 site in 1 country.
Spain1 site
School of Medicine and Dentistry
Santiago de Compostela, A Coruña, 15705
About this study
Official title: A Double Blind Randomized Clinical Trial Comparing the Risk of Gingival Irritation of Two Different Isolation Techniques Performed During In-Office Bleaching
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).
Read the detailed description
- 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.
- 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
- Being tested
- Relative Isolation, Absolute Isolation
- Keywords
- Gingival irritation, Vital Bleaching, In-Office bleaching, Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relative IsolationDevice
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
Absolute IsolationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Absolute Isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: -15 minutes after the first bleaching session - 15 minutes after the second bleaching session
Secondary outcomes (2)
Questionary of dental sensitivity
General tooth sensitivity was assessed using a 5-point Numeric Rating Scale (NRS), where 0 = no sensitivity; 1 = mild discomfort; 2 = moderate discomfort that does not interfere with daily activities; 3 = considerable discomfort leading to avoidance of certain foods and beverages; and 4 = severe sensitivity requiring interruption of the bleaching treatment. Participants selected the numeric value that best represented their perceived level of tooth sensitivity.
Pain intensity was recorded at the following time points:
- Perioperative
- 1 hour postoperatively
- 24 hours postoperatively
- 48 hours postoperatively
Measured: Perioperative , 1 hour postoperative, 24 hours postoperative, 48 hours postoperative.
Shade evaluation of each patient
Tooth color will be measured using a dental spectrophotometer, recording the following parameters: L (lightness, representing the shade from black to white on a scale of 0 to 100), a (color variation along the red-green axis, with positive values toward red/purple and negative values toward green/blue), b (color variation along the yellow-blue axis, with positive values toward yellow and negative values toward blue/purple), C (chroma, describing the intensity or saturation of a color, expressed on a scale from 0 to 40, where 0 indicates no saturation and 40 the maximum saturation), and hº (hue, representing the dominant wavelength of a color on a continuous circular scale from 0° to 360°).
Color changes between visits will be calculated using the CIELab, CIEDE2000, and White Index for Dentistry (WID) formulas.
Color measurements will be recorded at the following time points:
Baseline (Bleaching Day 1) One week after baseline (Before Bleaching Day 2) Follow-up (One week after)
Measured: Baseline, Before the first bleaching session, Revision (1 week after the 2 bleaching session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start15 May 2025
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival IrritationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double Blind, Clinical Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Pereira-Lores, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355673
- Sponsor's protocol ID
- 2025/02
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomized Clinical Trial Comparing the Risk of Gingival Irritation of Two Different Isolation Techniques Performed During In-Office Bleaching
- ClinicalTrials.gov ID
- NCT07355673
- Acronym / sponsor ID
- 2025/02
- Conditions
- Gingival Irritation
- Keywords
- Gingival irritation, Vital Bleaching, In-Office bleaching, Isolation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double Blind, Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Relative Isolation | Active comparator | Device: Relative IsolationThe 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. |
| Absolute isolation | Experimental | Device: Absolute IsolationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No oral os systemic pathology
- Periodontally Healthy
- No cavities
- Tooth shade of the canines A2 or darker
Key exclusion criteria (5 listed)
- Adhesive restorations or protheses in the anterior region
- Enamel or dentin alterations
- Smoking habits
- Pregnant women
- Undergone prior bleaching treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relative IsolationGeneral 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 | Relative Isolation |
| Absolute IsolationGeneral 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 | Device | Absolute isolation |
Primary outcome
Gingival Evaluation Recording
Time frame: -15 minutes after the first bleaching session - 15 minutes after the second bleaching session
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).
2 secondary outcomes
Questionary of dental sensitivity
Time frame: Perioperative , 1 hour postoperative, 24 hours postoperative, 48 hours postoperative.
Shade evaluation of each patient
Time frame: Baseline, Before the first bleaching session, Revision (1 week after the 2 bleaching session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relative Isolation and Absolute Isolation in people with Gingival Irritation, run by University of Santiago de Compostela at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Evaluation Recording (time frame: -15 minutes after the first bleaching session - 15 minutes after the second bleaching session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.