Comparative Clinical Evaluation of Three Different Agents in Reducing Dental Hypersensitivity in Periodontal Patients

Study Overview
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Brief Summary
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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
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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).

Official Title
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Comparative Clinical Evaluation of Three Different Technologies (Novamin, Refix and Refix-k) in Reducing Dental Hypersensitivity in Periodontal Patients

Conditions
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Dentin Hypersensitivity, Periodontal Diseases

Intervention / Treatment
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* Drug: Sensodyne Repair and Protect
* Drug: Dentalclean Daily Regenerator
* Drug: Dentalclean Daily Regenerator with potassium citrate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SEN GROUP<br>Sensodyne Repair and Protect - NOVAMIN technology | Drug: Sensodyne Repair and Protect<br>* Dentifricie with NOVAMIN technology<br>* Other names: Dentifrice with desensitizing agents;|
| Experimental: REG GROUP<br>Dentalclean Daily Regenerator - REFIX technology | Drug: Dentalclean Daily Regenerator<br>* Dentifricie with Refix technology<br>* Other names: Dentifrice with desensitizing agents;|
| Experimental: REGK GROUP<br>Dentalclean Daily Regenerator - REFIX technology + potassium citrate | Drug: Dentalclean Daily Regenerator with potassium citrate<br>* Dentifricie with Refix technology+ potassium citrate<br>* Other names: Dentifrice with desensitizing agents;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | T1- immediately before scaling and root planing procedures (SRP) | 
| 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. | T2 - immediately after scaling and root planing procedures (SRP) | 
| 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. | T3 - immediately after polishing sensitive areas with rubber cups and the dentifrice determined for each group of patients. | 
| 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. | T4 - 2 weeks after SRP. | 
| 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. | T5 - 4 weeks after SRP. | 
| 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. | T6 - 8 weeks after SRP. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | T1- immediately before scaling and root planing procedures (SRP) | 
| 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. | T2 - immediately after scaling and root planing procedures (SRP) | 
| 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. | T3 - immediately after polishing sensitive areas with rubber cups and the dentifrice determined for each group of patients. | 
| 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. | T4 - 2 weeks after SRP. | 
| 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. | T5 - 4 weeks after SRP. | 
| 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. | T6 - 8 weeks after SRP. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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root exposure, periodontal treatment, desensitizing agents.