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NCT Number: NCT06463938

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

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).

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Sanam Faheem

Karachi, Sindh, 75330, Pakistan

Location status: Recruiting

Location contact

Sanam Dr Faheem, MSC

CONTACT

[email protected]

021-38771000

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active comparator

Other

CPP-ACP paste will be applied on exposed area

Experimental Group

Device

Lasotronix will be applied following its protocol

Combination of laser and paste

Combination Product

This group will receive the combination of above two treatments

Control Group

Behavioral

this will be a control group

Primary outcomes

  1. treatment of dentin hypersensitivity

    Time frame: 0-3 moths

    VAS Visual analogue scale will be used to determine the efficacy of different treatment methods.

Study contacts

Contact information is provided by the study sponsor or research team.

Chandar Dr Kumar

CONTACT

[email protected]

021-38771000

Sanam Dr Faheem, MSc

CONTACT

[email protected]

021-38771000

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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