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NCT06463938 Clinical Trial

A Clinical Trial to Compare Lasotronix Alone or in Combination With CPP-ACP to Treat DH

Dentin Sensitivity Clinical Trial

Official title:
A Clinical Study to Evaluate the Effectiveness of Casein Phosphopeptide, Amorphous Calcium Phosphate Paste (CPP-ACP) Used Alone or in Combination With Lasotronix (Diode Laser) to Treat Dentin Hypersensitivity

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06463938
Other study ID # Dow
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 12, 2024
Est. completion date December 10, 2024

Study information
Verified date June 2024
Source Dow University of Health Sciences
Contact Sanam Dr Faheem, MSc
Phone 021-38771000
Email sanam.faheem@duhs.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Dentin hypersensitivity (DH) is defined as sharp pain of a shorter duration arise from exposed dentin in response to several chemicals and thermal or tactile stimuli that cannot be ascribed to other dental defects". DH has a prevalence rate ranging from 1.3% to 92.1%, commonly affecting old ages. The use of laser has opened new dimensions in the treatment of DH. To the author's knowledge, not much research work has been conducted using LASOTRONIX as a treatment modality with CPP-ACP. Therefore, this research aims to determine the effectiveness of Casein phospho peptide paste (CPP-ACP) used alone or combined with a diode laser (LASOTRONIX).

Description:

DH has a prevalence rate ranging from 1.3% to 92.1%, commonly affecting old ages, and the frequency of DH in patients suffering from periodontal disease is 3-57%. Pakistan has reported prevalence from different cities, with 36.4% from Karachi and 22% from Lahore. The use of laser has opened new dimensions in the treatment of DH. Theories that support laser therapy explain that irradiation blocks the pain in dentinal tubules by melting and recrystallization of dentin or by tertiary dentine production or evaporation of dentinal fluid. Considering the oral soft tissues which contain high amounts of water, Lasotronix SMARTm laser diodes have been carefully designed to show their high transmission. The 635nm wavelength is optimal for activating tolonium chloride dye for photo-activated chemo therapy, eliminating all bacteria and biofilms without any side effects. 200 mW power provides safe cold bio stimulation and photo disinfection within a reasonably short therapy time. Application of Sodium fluoride (NaF) has also been indicated for hypersensitivity pains. Its application in the form of gel occludes the tubule by calcium fluoride precipitation. Agents like potassium nitrate also have promising effects, which increase the concentration of potassium ions in nerve endings and alter the nerve action potential in conducting the sensory stimuli. Recently DH treatment has been conducted with different types of laser with different wavelengths, either alone or in combination with desensitizing agents and varnishes and has revealed effective results. To the author's knowledge, not much research work has been conducted using LASOTRONIX as a treatment modality with CPP-ACP. Therefore, this research aims to determine the effectiveness of Casein phospho peptide paste (CPP-ACP) used alone or combined with a diode laser (LASOTRONIX).

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date December 10, 2024
Est. primary completion date October 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 65 Years
Eligibility Inclusion criteria: - Patients of either gender, with ages between 25-65 years - should have at least more than one hypersensitive and vital tooth without any carious lesion or defective restoration Exclusion criteria: - History of desensitizing therapy on the affected tooth/teeth in last six months (use of desensitizing toothpaste) - use of antibiotics /analgesic/anti-inflammatory drugs - history of smoking - pregnancy - those who are not willing to participate or give follow-ups

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Active comparator
CPP-ACP paste will be applied on exposed area
Device:
• Experimental group
Lasotronix will be applied following its protocol
Combination Product:
• Combination of laser and paste
This group will receive the combination of above two treatments
Behavioral:
• Control group
this will be a control group

Locations
Country Name City State
Pakistan Dr Sanam Faheem Karachi Sindh

Sponsors (1)
Lead Sponsor Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary treatment of dentin hypersensitivity VAS Visual analogue scale will be used to determine the efficacy of different treatment methods. 0-3 moths
See also
  Status Clinical Trial Phase
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Completed NCT02861664 - Assessment of the Efficacy of an Experimental Occlusion Technology Dentifrice in Dentinal Hypersensitivity N/A
Completed NCT02542943 - Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity N/A
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Completed NCT02919202 - Clinical Trial to Compare the Efficacy of a Fluoride Gel and a Dental Bonding Agent in Treatment of Tooth Sensitivity N/A
Not yet recruiting NCT04485299 - Clinical Assessment of Bifluorid 10 vs Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient Phase 2/Phase 3
Completed NCT02931734 - Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment N/A
Completed NCT02923895 - To Investigate the Efficacy of an Occluding Dentifrice in Dentinal Hypersensitivity (DH) Phase 4
Withdrawn NCT03361774 - A Clinical Method Development Study to Characterise The Efficacy of a Dentifrice For The Relief Of Dentin Hypersensitivity Phase 2
Completed NCT02924350 - The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity (DH) N/A
Completed NCT05083052 - Propolis in Reducing Dentin Hypersensitivity N/A
Active, not recruiting NCT06150573 - A Study Assessing the Effects of an Experimental Dentifrice in Maintaining Tooth Color Following Tooth Bleaching N/A
Completed NCT02937623 - To Evaluate the Efficacy of an Experimental Dissolvable Strip in Rapidly Relieving Dentinal Hypersensitivity (DH) N/A
Completed NCT02612064 - The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity N/A
Completed NCT02293044 - A Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity N/A
Completed NCT02128633 - Effectiveness of a Homecare Dentin Hypersensitivity Gel Phase 2/Phase 3
Completed NCT03310268 - A Clinical Study to Evaluate a Stannous Fluoride Toothpaste for the Relief of Dentinal Hypersensitivity N/A
Completed NCT05750745 - A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population N/A
Not yet recruiting NCT06417580 - Effect of Pregabalin Gel in Controlling Cervical Dentin Hypersensitivity Phase 2