Comparative Clinical Evaluation of Three Different Agents in Reducing Dental Hypersensitivity in Periodontal Patients
Primary Purpose
Dentin Hypersensitivity, Periodontal Diseases
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Sensodyne Repair and Protect
Dentalclean Daily Regenerator
Dentalclean Daily Regenerator with potassium citrate
Sponsored by
About this trial
This is an interventional treatment trial for Dentin Hypersensitivity focused on measuring root exposure, periodontal treatment, desensitizing agents.
Eligibility Criteria
Inclusion Criteria:
- patients diagnosed with periodontitis
- 18 to 70 years old
- systemically healthy
- without any allergy to the dentifrices components
- patients who needed scaling and root planing procedures
- patients who had at least 2 teeth with DH (incisors, canines or premolars).
Exclusion Criteria:
- pregnancy
- patients in orthodontic treatment
- patients with oral tumors, caries, fractured teeth, suspected endodontic involvement or excessive mobility;
- patients who used medication that could mask the painful sensation or who had used desensitizing agents in the last 3 months.
Sites / Locations
- Bauru School of DenstistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
SEN GROUP
REG GROUP
REGK GROUP
Arm Description
Sensodyne Repair and Protect - NOVAMIN technology
Dentalclean Daily Regenerator - REFIX technology
Dentalclean Daily Regenerator - REFIX technology + potassium citrate
Outcomes
Primary Outcome Measures
Professional evaluation of Dentin Hypersensitivity
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Professional evaluation of Dentin Hypersensitivity
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Professional evaluation of Dentin Hypersensitivity
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Professional evaluation of Dentin Hypersensitivity
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Professional evaluation of Dentin Hypersensitivity
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Professional evaluation of Dentin Hypersensitivity
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Secondary Outcome Measures
Patient's perception of DH
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Patient's perception of DH
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Patient's perception of DH
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Patient's perception of DH
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Patient's perception of DH
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Patient's perception of DH
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Full Information
NCT ID
NCT04422184
First Posted
May 29, 2020
Last Updated
September 27, 2021
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT04422184
Brief Title
Comparative Clinical Evaluation of Three Different Agents in Reducing Dental Hypersensitivity in Periodontal Patients
Official Title
Comparative Clinical Evaluation of Three Different Technologies (Novamin, Refix and Refix-k) in Reducing Dental Hypersensitivity in Periodontal Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 29, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The present project will compare the effect of DH reduction using three different dentifrices (Sensodyne Repair and Protect - NOVAMIN technology; Dentalclean Daily Regenerator - REFIX technology; Dentalclean Daily Regenerator - REFIX technology + potassium citrate) in periodontal patients. The evaluation will be in 6 moments: T1 and T2- immediately before and after scaling and root planing (SRP) procedures; T3-after polishing sensitive areas with rubbers cups and the dentifrice determined for each group of patients and T4, 5, 6- After 2, 4 and 8 weeks of SRP. Profissional assessments and patient perception data will be performed.
Detailed Description
Periodontal patients may report dentinal hypersensitivity (DH) caused by root surface exposure as part of disease process or as a result of periodontal treatment. Although some studies evaluated DH reduction using desensitizing toothpastes, no specific chemical/physical agent is reported for periodontal patients. Thus, the present project will compare the effect of DH reduction using three different dentifrices (Sensodyne Repair and Protect - NOVAMIN technology; Dentalclean Daily Regenerator - REFIX technology; Dentalclean Daily Regenerator - REFIX technology + potassium citrate) in periodontal patients. This randomized, parallel and blinded clinical trial will be divided into 3 groups (SEN GROUP: Sensodyne; REG GROUP: Regenerator; REGK GROUP: Regenerator + Potassium Citrate) and evaluated at 6 moments: T1 and T2- immediately before and after scaling and root planing (SRP) procedures; T3-after polishing sensitive areas with rubbers cups and the dentifrice determined for each group of patients and T4, 5, 6- After 2, 4 and 8 weeks of SRP. Air blast sensitivity assessments (Schiff scale) and patient perception data on DH will be performed using visual analog scales (VAS). The comparison between treatment groups will be done by paired T-test if normal distribution is observed or Wilcoxon if non-normal distribution. The significance level adopted will be 5% (p <0.05).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity, Periodontal Diseases
Keywords
root exposure, periodontal treatment, desensitizing agents.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SEN GROUP
Arm Type
Experimental
Arm Description
Sensodyne Repair and Protect - NOVAMIN technology
Arm Title
REG GROUP
Arm Type
Experimental
Arm Description
Dentalclean Daily Regenerator - REFIX technology
Arm Title
REGK GROUP
Arm Type
Experimental
Arm Description
Dentalclean Daily Regenerator - REFIX technology + potassium citrate
Intervention Type
Drug
Intervention Name(s)
Sensodyne Repair and Protect
Other Intervention Name(s)
Dentifrice with desensitizing agents
Intervention Description
Dentifricie with NOVAMIN technology
Intervention Type
Drug
Intervention Name(s)
Dentalclean Daily Regenerator
Other Intervention Name(s)
Dentifrice with desensitizing agents
Intervention Description
Dentifricie with Refix technology
Intervention Type
Drug
Intervention Name(s)
Dentalclean Daily Regenerator with potassium citrate
Other Intervention Name(s)
Dentifrice with desensitizing agents
Intervention Description
Dentifricie with Refix technology+ potassium citrate
Primary Outcome Measure Information:
Title
Professional evaluation of Dentin Hypersensitivity
Description
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Time Frame
T1- immediately before scaling and root planing procedures (SRP)
Title
Professional evaluation of Dentin Hypersensitivity
Description
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Time Frame
T2 - immediately after scaling and root planing procedures (SRP)
Title
Professional evaluation of Dentin Hypersensitivity
Description
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Time Frame
T3 - immediately after polishing sensitive areas with rubber cups and the dentifrice determined for each group of patients.
Title
Professional evaluation of Dentin Hypersensitivity
Description
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Time Frame
T4 - 2 weeks after SRP.
Title
Professional evaluation of Dentin Hypersensitivity
Description
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Time Frame
T5 - 4 weeks after SRP.
Title
Professional evaluation of Dentin Hypersensitivity
Description
Air blast sensitivity evaluated by an experienced dentist (Schiff scale) Score 0 = Tooth/Subject does not show sensitivity in response to air stimulation; 1 = Tooth/Subject responds to air stimulus, but does not request discontinuation of stimulus; 2 = Tooth/Subject responds to air stimulus, and requests discontinuation or moves from stimulus; 3 = Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Time Frame
T6 - 8 weeks after SRP.
Secondary Outcome Measure Information:
Title
Patient's perception of DH
Description
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Time Frame
T1- immediately before scaling and root planing procedures (SRP)
Title
Patient's perception of DH
Description
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Time Frame
T2 - immediately after scaling and root planing procedures (SRP)
Title
Patient's perception of DH
Description
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Time Frame
T3 - immediately after polishing sensitive areas with rubber cups and the dentifrice determined for each group of patients.
Title
Patient's perception of DH
Description
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Time Frame
T4 - 2 weeks after SRP.
Title
Patient's perception of DH
Description
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Time Frame
T5 - 4 weeks after SRP.
Title
Patient's perception of DH
Description
Patient's perception of DH was also evaluated with visual analogue scale (VAS), being 0 without any painful sensation and 100 the most painful scenario.
Time Frame
T6 - 8 weeks after SRP.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients diagnosed with periodontitis
18 to 70 years old
systemically healthy
without any allergy to the dentifrices components
patients who needed scaling and root planing procedures
patients who had at least 2 teeth with DH (incisors, canines or premolars).
Exclusion Criteria:
pregnancy
patients in orthodontic treatment
patients with oral tumors, caries, fractured teeth, suspected endodontic involvement or excessive mobility;
patients who used medication that could mask the painful sensation or who had used desensitizing agents in the last 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariana S Ragghianti Zangrando, Prof
Phone
14996962250
Email
mariana@fob.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Giovana Favero
Email
giovannaffavero@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana S Ragghianti Zangrando, Prof
Organizational Affiliation
USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bauru School of Denstistry
City
Bauru
State/Province
SP
ZIP/Postal Code
17012-901
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana S Ragghianti Zangrando, Prof
Email
mariana@fob.usp.br
First Name & Middle Initial & Last Name & Degree
Giovana Favero
Email
giovannaffavero@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25495777
Citation
West NX, Seong J, Davies M. Management of dentine hypersensitivity: efficacy of professionally and self-administered agents. J Clin Periodontol. 2015 Apr;42 Suppl 16:S256-302. doi: 10.1111/jcpe.12336.
Results Reference
background
PubMed Identifier
25961613
Citation
Patil SA, Naik BD, Suma R. Evaluation of three different agents for in-office treatment of dentinal hypersensitivity: a controlled clinical study. Indian J Dent Res. 2015 Jan-Feb;26(1):38-42. doi: 10.4103/0970-9290.156796.
Results Reference
background
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Comparative Clinical Evaluation of Three Different Agents in Reducing Dental Hypersensitivity in Periodontal Patients
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