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Study aim
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Comparison of the Effectiveness of Nano hydroxyapatite (n-HAP) with Potassium nitrate (KNO3) in Dental Hypersensitivity secondary to Periodontal Surgery Treatment in moderated to severe Periodontitis Patients
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Design
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Clinical trials, with Parallel Groups, Double-blinded and Randomized.
Sampling Method is randomly available among Individuals referring to Periodontics Department of Tabriz Dental Faculty. The randomization Method is simple and the Unit is individual, our Tool for randomization is randomized Number Chart. Also, the Allocation of Toothpaste to Patients is done randomly. In this Way, the type of Toothpaste is identified with Code A (Sensodyne) and B (Pharmed) and sealed in Envelopes; then the Envelopes are placed in a Box and stirred Then they are randomly chosen from the Box and after observing the Code, the Toothpaste will be given to the Patient. None of the Patients will be informed about Another Patient's Toothpaste. Operator who evaluating dental Hypersensitivity is not informed about Type of Toothpaste.
based on statistical Analysis Sample Size will be contained 22 Persons. Afterward They are divided in 2 groups; Sensodyne Toothpaste Recipients and Pharmed. dental Hypersensitivity is evaluated at first Visit, 15 Days later and finally on 30th Day for each Individual. The Test consists a Ranking of 1 to 10 that the Patient shows to the Sensitivity of his/her Teeth against Touch, cold and hot Stimulants. The two Groups will be unified based on Age and Gender. The Sampling Method in this Study includes considering the Difference of 1 unit between Tooth Pain in response to Stimulants after using Pharmed and Sensodyne Toothpaste with a standard Deviation of 1.45 (and adding 10% to this Number), 1.6. Also considering α = 0.05 and Power of 80%, 10 Samples will be selected in each Group; Finally 10% will be added to this Number and 11 People will be selected for each Group in order to increase the Validity of this Study and eliminating Mistakes caused by dropped out Individuals during Implementation of the Plan.
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Settings and conduct
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This Study is a clinical Trial that will be carried out in the Periodontics Department of Tabriz dental Faculty. According to the statistical Analysis the Sample Size will be 22 People. Then They are divided into two Groups: Those who received Sensodyne Toothpaste is contained Potassium Nitrate and Pharmed Toothpaste is contained Nano Hydroxyapatite. The two Groups will be assimilated based on Age and Gender. Dental Hypersensitivity is determined at the Beginning of the Period, then on the fifteenth Day, and finally on 30th Day for each Individual. The Test consists of a Score of 1 to 10 that the Patient gives to the Sensitivity of the Teeth in Touch, cold and hot Stimulants.
it is a double-blind Fashion Study. None of the Participant does not know which Toothpaste another Participant will receive. Also Participants are not informed about Types of Toothpaste and the other Participants. The Operator evaluating dental Hypersensitivity will be blinded too.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age Range 15 to 60 Years
Dental Hypersensitivity should be confirmed by an experienced Clinician
Gingival Retraction secondary to Periodontal Surgery should be existed in Participant's Dentition
Presence of At least Three sensitive Teeth
Periodontal Diseases have been treated by Periodontal Surgery
Exclusion criteria:
Allergy to the Contents of Toothpaste
Generalized Pathology in Oral Cavity
Systemic chronic Disease
Sensitive Teeth with Mobility Higher than Grade 1
Sensitive Teeth with Extent Restoration, Defect or Prosthetic Crown
Sensitive Teeth suspected to Pulpitis, enamel Crack, Caries
Abutment Teeth of removable Partial Denture
People taking Anti epileptic, Antihistamine, Antidepressant, Antiinflamatory, Sedative Drugs or Analgesics
Pregnant and Lactating Women
Participants in similar Studies or People who have received any kind of Desensitizing Products
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Intervention groups
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Group No.1: Participants who use Desensitizing Sensodyne Toothpaste which contains Potassium Nitrate for relieving dental Hypersensitivity following Periodontal Surgery.
Group No2: Desensitizing Pharmed Toothpaste Recipients containing Nano Hydroxyapatite to reduce Postoperative dental Hypersensitivity following Periodontal Surgery.
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Main outcome variables
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The amount of Pain in response to cold, hot and Touch Stimulants at first Visit and then after 15 Days and 30 Days later; by Using Visual Analogue Scale
Type of desensitizing Material in Toothpaste, containing Nano Hydroxyapatite in Pharmed Toothpaste and Potassium Nitrate in Sensodyne Toothpaste
Time of Pain Evaluation for Participants in 3 Steps: first Visit, 15 Days later and 30 Days later