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Use of Refix Technology gel with Calcium combined with Low-Level Laser Therapy in the treatment of Cervical Dentin Hypersensitivity: a randomized controlled clinical trial

Gel with Refix Technology and Calcium associated with Low-Level Laser Therapy in the treatment of Cervical Dentin Hypersensitivity: a controlled and randomized clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-66gbrkj
Enrollment
252
Registered
2026-03-19
Start date
2025-02-15
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentin sensitivity Oral Health

Interventions

This is a randomized, controlled, single-blind clinical study. A total of 252 participants with cervical dentin hypersensitivity (CDH) will be included, presenting four distinct clinical situations: a
b) clinical situation II (n = 48): teeth with NCCL
c) clinical situation III (n = 75): teeth without NCCL submitted to scaling and root planing
and d) clinical situation IV (n = 84): teeth with NCCL submitted to scaling and root planing. After inclusion, participants will be divided into four groups according to the treatment group using a ra

Sponsors

Faculdade de Odontologia da Universidade Federal de Uberlândia
Lead Sponsor
Faculdade de Odontologia da Universidade Federal de Uberlândia
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 to 60 years will be included; in good general health; presenting at least one tooth with exposed vestibular cervical dentin associated with symptoms of cervical dentin hypersensitivity, confirmed by a positive response to a 2-second air jet applied with an air-water syringe. To be eligible, the patient must register a minimum score of 40 mm on a 100 mm Visual Analog Scale (VAS). Teeth with non-carious cervical lesions (NCCL) with dentin loss greater than 2 mm in depth, requiring restorative intervention associated with dentin hypersensitivity, will be included with the same inclusion criteria. Differential diagnosis will be performed to exclude other pathologies, and the vitality of all teeth will be verified before, after treatment, and during follow-up periods, using vertical and horizontal percussion tests, as well as periapical radiographs.

Exclusion criteria

Exclusion criteria: Teeth with evidence of pulpal pathology or loss of vitality; carious lesions; deficient restorations; premature contacts; enamel cracks; active periodontal disease; or tooth mobility greater than grade I will be excluded. Individuals presenting any of the following conditions will also be excluded: existing medical conditions; eating disorders (e.g., bulimia) or diets causing dental erosion and/or wear; history of adverse reactions to any oral hygiene products; use of daily medications that interfere with pain perception, including sedatives, tranquilizers, analgesics, anticonvulsants, and anti-inflammatory drugs within the last 72 hours; use of any desensitizing agents or dental bleaching within the last 3 months, or those who have undergone periodontal surgeries for root coverage within the last 12 months. Pregnant or lactating women will also be excluded from the study.

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study will be pain, assessed using the Visual Analog Scale (VAS). The VAS is used to quantify pain intensity in millimeters (mm) following the application of a stimulus and is considered, according to the literature, an appropriate tool for pain measurement. Its advantages include a continuous scale format, ease of understanding for patients, and the ability to discriminate between different levels of pain, including pain associated with cervical dentin hypersensitivity. The scale consists of a 100-mm horizontal line anchored at the left end with the descriptor “no pain” and at the right end with “unbearable pain.” Patients will be instructed to mark their pain intensity along the line, allowing for the assessment of hypersensitivity severity. Scores will be interpreted as follows: 0–10 mm, no pain; 20–30 mm, mild pain; 40–60 mm, moderate pain; and 70–100 mm, severe pain.

Secondary

MeasureTime frame
Examiner Assessment (Schiff Cold Air Sensitivity Scale). Before patients record their response to the evaporative sensitivity test on the VAS, sensitivity will be evaluated by the examiner using the Schiff Cold Air Sensitivity Scale. In this test, patient responses to the stimulus are recorded according to the following scale, where higher scores indicate greater levels of dentin hypersensitivity: [0] The patient does not respond to the stimulus (no significant discomfort or awareness of the stimulus); [1] The patient responds to the stimulus but does not request its discontinuation (mild discomfort without intense pain); [2] The patient responds to the stimulus and requests discontinuation or moves away from the stimulus (pain during application); [3] The patient responds to the stimulus, considers it painful, and requests its discontinuation (severe pain during and after stimulus application).;The Dentine Hypersensitivity Experience Questionnaire (DHEQ) was developed to identify functional limitations, coping behaviors, and emotional and social impacts caused by dentin hypersensitivity (DH). The original DHEQ contains 50 items distributed across five subscales: "restrictions," "adaptation," "social impact," "emotional impact," and "identity." The short version (DHEQ-15) consists of 15 items organized within the same five subscales. In the DHEQ-15, responses are provided on a seven-point Likert scale, coded according to the degree of agreement from 1 to 7. The total score is calculated as the sum of the 15 item scores (possible range 15–105 points) for each participant. Subscale scores are calculated in the same manner. The proportion of impacts is determined by the number of items with which the participant indicated agreement (“strongly agree,” “agree,” or “somewhat agree”). Higher DHEQ-15 scores indicate a greater negative impact on quality of life.

Countries

BR

Contacts

Public ContactCamila ;Suzane Brant;Pigossi

Faculdade de Odontologia da Universidade Federal de Uberlândia;Faculdade de Odontologia da Universidade Federal de Uberlândia

camila.brant@ufu.br;suzane.pigossi@ufu.br+55 (37) 99804-1595;+55 (19) 98141-4158

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Apr 4, 2026