Clinical Trial: Use of Biomaterials as Desensitizer Agents

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Long-term Response of Three Biomaterials Used as Desensitizer Agents Under Oral Environmental Exposure.

Brief Summary:

Aim: to investigate the clinical effectiveness over 12 weeks of three different biomaterials, nano-hydroxyapatite based, in the therapy of the dental sensitivity.

Methods: The study is designed as a randomized clinical trial comparing: 1) Cavex Bite&White ExSense, 2) Teethmate™ Desensitizer , 3) Ghimas Dentin Desensitizer. The pain experience was generated by a cold stimulus directly to a sensitive tooth surface and assessed using the Visual Analogue Scale (VAS). The response was recorded before the application of the materials (PRE-1), immediately after (POST-1), at 1-week (POST-2), 4-weeks (POST-3) and 12-week controls (POST-4).

Detailed Summary:

Participants The study is designed as randomized clinical trial. The participants will be selected from the regular attenders of the Dental Clinic in the University of Sassari, Italy.

Inclusion criteria:

• patients will be considered suitable for the study if they have sensitive teeth showing abrasion, erosion, or recession with the exposure of the cervical dentine;

Exclusion criteria:

• teeth with subjective or objective evidence of carious lesions, pulpitis, restorations, premature contact, cracked enamel, active periapical infection, or which had received periodontal surgery or root-planning up to 6 months prior to the investigation will be excluded from the study
• professional desensitizing therapy during the previous 3 months, or use of desensitizing toothpaste in the last 6 weeks.
• Patients will be also excluded if they will be under significant medication that could interfere with pain perception (e.g., antidepressants, anti-inflammatory drugs, sedatives, and muscle relaxants).

Randomization Using a computer program (Excel 2010 for Mac OsX), the randomization will be carried on using an individual basis.

Clinical procedure A full medical and dental history will be taken and all the teeth will be carefully examined to confirm the diagnosis of DH. The experience of dentinal hypersensitivity and how this has affected the quality of life of the patients will be evaluated through a specific questionnaire. The nature and scope of the study will be explained and informed consent will be obtained.

The pain experience was assessed by a Visual Analogue Scale (VAS) using the methodology. The VAS scale consisted of a horizontal line that was 100 mm long, on which 'no pain' was marked on the right-hand extremity and 'unbearable pain' on the other. The patients expressed the intensity of the pain experienced by placing a mark at any point along the continuum. The distance, expressed in millimetres, from the right edge of 'no pain' was used as the VAS score. Each patient was asked to rate the perception of discomfort after the application of air via a dental syringe at 45-60 psi, 1 cm at the cervical third of the tooth after removing supragingival plaque with a low- speed handpiece with pumice powder and without fluoride. The adjacent teeth were covered by cotton rolls. The stimulus was delivered until reaction or up to a maximum duration of 10 s by the same examiner with the same equipment yielding similar air pressure each time.