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Clinical evaluation of restorations located close to the gums using universal adhesives

Interaction of universal dentin bonding systems of non carious cervical lesions: a randomized clinical controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-63q9z47
Enrollment
Unknown
Registered
2025-02-19
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Tooth erosion

Interventions

The clinical study will be a controlled, interventional, randomized, and prospective trial with a double-blind design (including both assessors/examiners and participants) and a split-mouth approach,
and 2) Time in six levels: initial, 7 days, 6 months, 12 months, 18 months, 2 years, and 5 years. The experimental unit will be the patient (n=35).
E05.318.372.250.250.365.500

Sponsors

Faculdade de Odontologia de Bauru, Universidade de São Paulo
Lead Sponsor
Clinica Multidisciplinar
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients of any gender; at least 18 years old; good general health; acceptable oral hygiene; presence of at least 20 teeth in occlusion; two or more teeth (in occlusion, vital and without mobility) with similar cervical lesions predominantly caused by Erosive Tooth Wear and with a supragingival margin

Exclusion criteria

Exclusion criteria: Caries activity; systemic health complications; active or chronic periodontal disease; severe bruxism or other parafunctional habits; patients using a complete denture or implants occluding with the teeth of interest; patients who have undergone orthodontic, hypersensitivity or whitening treatment in the last 6 months; pregnant or breastfeeding women; allergies to the main components of the products used in this study; unavailability of time

Design outcomes

Primary

MeasureTime frame
Clinical Performance: will be evaluated at each return visit using two evaluation methods: modified USPHS and FDI. Both methods present pre-determined categories and scores regarding the functional and aesthetic characteristics of the restorations.

Secondary

MeasureTime frame
Participants' degree of sensitivity: It will be measured and reported by the patient using a Visual Analogue Scale (VAS) from 0 to 10, with 0 - no pain and 10 - intolerable pain.;Analysis of participants' quality of life: For this analysis, the OHIP-14 questionnaire will be used with the objective of evaluating the impact of non-carious cervical lesions on functional limitation, physical pain, psychological discomfort, physical disability, psychological disability and social disability of the participants. Each participant must answer 14 questions using a Likert scale, from zero to four, with 0 corresponding to never, 1 to rarely, 2 to sometimes, 3 to frequently and 4 to always.;Classification of participants' risk of Erosive Dental Wear (DDE): It will be assessed using the BEWE Index (Basic Erosive Wear Examination). In this method, each tooth surface will be classified according to the score from 0 to 3 (0 - no signs of erosive wear, 1 - initial loss of surface texture, 2 - distinct defect, with less than 50% surface involvement, and 3 - involvement greater than 50% of the tooth structure). The sum of the highest scores observed in each dental sextant of the patient determines their risk level as zero (0-2), low (3-8), medium (9-13) and high (14-18).;Degree of dentin sclerosis: The sclerosis of each lesion will be measured using an scale in which dentin is classified according to its optical characteristics by the evaluator in a grade from 1 to 4.

Countries

Brazil

Contacts

Public ContactLinda;Mylena Wang;Costa

Faculdade de Odontologia de Bauru, Universidade de São Paulo;Faculdade de Odontologia de Bauru, Universidade de São Paulo

wang.linda@usp.br;mylena.costa@usp.br+55(14)32358480;+5515996987908

Outcome results

None listed

Source: REBEC (via WHO ICTRP)