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Use of Biomaterials as Desensitizer Agents

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ClinicalTrials.gov Identifier: NCT02770573
Recruitment Status : Active, not recruiting
First Posted : May 12, 2016
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Egle Milia, Università degli Studi di Sassari

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).


Condition or disease Intervention/treatment Phase
Dentin Sensitivity Other: Cavex Bite&White ExSense Other: Kuraray Teethmate™ Desensitizer Other: Ghimas Dentin Desensitizer Not Applicable

Detailed Description:

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.

A week before the experiment, patients received oral prophylaxis. Non-fluoride toothpaste, soft tooth- brush and oral hygiene instructions will be also provided in order to have standardized habits during the period of the study.

A week before the experiment, patients received oral prophylaxis. Non-fluoride toothpaste (Biorepair, Coswell), a soft toothbrush (Oral-B Sensitive Advantage, Procter & Gamble) and oral hygiene instructions were also provided. The level of sensitivity experienced by each patient was considered as independent of the position of the hypersensitive tooth in the oral cavity. The pain experience was assessed by a Visual Analogue Scale (VAS) using the methodology described in our previous study. The pain experience was measured using a VAS graded from 1 to 10. The pain stimulus was given by one examiner with the same equipment yielding similar air pressure each time, while another one performed the treatments.

Teeth will be randomly assigned to three groups (N= per group) for the treatment with the three desensitizing agents.

The following dental materials were used following the manufacturers' instructions:

  1. Cavex Bite&White ExSense (Cavex Holland BV, RW Haarlem, The Netherlands), a water-based mint aroma gel containing hydroxyapatite and potassium nitrate.
  2. Kuraray Teethmate™ Desensitizer (Kuraray Noritake Dental, Osaka, Japan), Calcium-Phosphate-based powder and a liquid mainly water-based.
  3. Ghimas Dentin Desensitizer (Ghimas, Bologna, Italy), a fluid desensitizing gel with 30% of nano-hydroxyapatite, added to 70:100 thousandths of micron-sized crystals of nano- hydroxyapatite.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Response of Three Biomaterials Used as Desensitizer Agents Under Oral Environmental Exposure.
Actual Study Start Date : March 2016
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Patients with dentin hypersensitivity

Patients with evident clinical signs of dentin hypersensitivity The following dental materials will be used following the manufacturers' instructions: Cavex Bite&White ExSense; Kuraray Teethmate™ Desensitizer; Ghimas Dentin Desensitizer.

In view of the treatment with the desensitizing agents, teeth were randomly assigned into four groups.

The application of the materials will be made only once. The effectiveness will be evaluated: immediately after application and after 1, 4, 12 weeks.

Other: Cavex Bite&White ExSense
a water-based mint aroma gel containing hydroxyapatite and potassium nitrate.

Other: Kuraray Teethmate™ Desensitizer
Calcium-Phosphate-based powder and a liquid mainly water-based.

Other: Ghimas Dentin Desensitizer
a fluid desensitizing gel with 30% of nano-hydroxyapatite, added to 70:100 thousandths of micron-sized crystals of nano- hydroxyapatite.




Primary Outcome Measures :
  1. Evaluation of change of dentinal hypersensitivity after treatment [ Time Frame: before the treatment (PRE-1), immediately after (POST-1), after 1 week (POST-2), 4 weeks (POST-3), and 12 weeks (POST-4). ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• patients will be considered suitable for the study if they had 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770573


Locations
Italy
Complex Operative Unit of Dentistry
Sassari, Italy, 07100
Sponsors and Collaborators
Università degli Studi di Sassari
Investigators
Principal Investigator: Egle Milia, Prof Università degli Studi di Sassari

Additional Information:
Publications:
Responsible Party: Egle Milia, Prof, Università degli Studi di Sassari
ClinicalTrials.gov Identifier: NCT02770573     History of Changes
Other Study ID Numbers: DH 2304/CE
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not a plan for data sharing has been established. But, for anyone researcher would like to have this information, simply they may request them to us directly.

Keywords provided by Egle Milia, Università degli Studi di Sassari:
nano-hydroxyapatite

Additional relevant MeSH terms:
Dentin Sensitivity
Tooth Diseases
Stomatognathic Diseases