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Use of Biomaterials as Desensitizer Agents

Primary Purpose

Dentin Sensitivity

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cavex Bite&White ExSense
Kuraray Teethmate™ Desensitizer
Ghimas Dentin Desensitizer
Sponsored by
Università degli Studi di Sassari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Sensitivity focused on measuring nano-hydroxyapatite

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Complex Operative Unit of Dentistry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with dentin hypersensitivity

Arm Description

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.

Outcomes

Primary Outcome Measures

Evaluation of change of dentinal hypersensitivity after treatment
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.

Secondary Outcome Measures

Full Information

First Posted
May 11, 2016
Last Updated
April 19, 2017
Sponsor
Università degli Studi di Sassari
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1. Study Identification

Unique Protocol Identification Number
NCT02770573
Brief Title
Use of Biomaterials as Desensitizer Agents
Official Title
Long-term Response of Three Biomaterials Used as Desensitizer Agents Under Oral Environmental Exposure.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Sassari

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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: Cavex Bite&White ExSense (Cavex Holland BV, RW Haarlem, The Netherlands), a water-based mint aroma gel containing hydroxyapatite and potassium nitrate. Kuraray Teethmate™ Desensitizer (Kuraray Noritake Dental, Osaka, Japan), Calcium-Phosphate-based powder and a liquid mainly water-based. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity
Keywords
nano-hydroxyapatite

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with dentin hypersensitivity
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cavex Bite&White ExSense
Intervention Description
a water-based mint aroma gel containing hydroxyapatite and potassium nitrate.
Intervention Type
Other
Intervention Name(s)
Kuraray Teethmate™ Desensitizer
Intervention Description
Calcium-Phosphate-based powder and a liquid mainly water-based.
Intervention Type
Other
Intervention Name(s)
Ghimas Dentin Desensitizer
Intervention Description
a fluid desensitizing gel with 30% of nano-hydroxyapatite, added to 70:100 thousandths of micron-sized crystals of nano- hydroxyapatite.
Primary Outcome Measure Information:
Title
Evaluation of change of dentinal hypersensitivity after treatment
Description
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.
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).

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egle Milia, Prof
Organizational Affiliation
Università degli Studi di Sassari
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complex Operative Unit of Dentistry
City
Sassari
ZIP/Postal Code
07100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
22891890
Citation
Milia E, Castelli G, Bortone A, Sotgiu G, Manunta A, Pinna R, Gallina G. Short-term response of three resin-based materials as desensitizing agents under oral environmental exposure. Acta Odontol Scand. 2013 May-Jul;71(3-4):599-609. doi: 10.3109/00016357.2012.700063. Epub 2012 Aug 15.
Results Reference
background
PubMed Identifier
25609032
Citation
Pinna R, Bortone A, Sotgiu G, Dore S, Usai P, Milia E. Clinical evaluation of the efficacy of one self-adhesive composite in dental hypersensitivity. Clin Oral Investig. 2015 Sep;19(7):1663-72. doi: 10.1007/s00784-014-1390-3. Epub 2015 Jan 23.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=Derchi+G+Effectiveness+of+nano-hydroxyapatite+toothpaste+in+reducing+dentin+hypersensitivity%3A+A+double-blind+randomized+controlled+trial
Description
Effectiveness of nano-hydroxyapatite toothpaste in reducing dentin hypersensitivity: a double-blind randomized controlled trial.

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Use of Biomaterials as Desensitizer Agents

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