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RecruitingNCT06463938Updated Jul 26, 2024

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

An interventional study of Active comparator and Experimental group in Dentin Sensitivity, Hypersensitivity and Cervical Lesion, sponsored by Dow University of Health Sciences. Recruiting at 1 site in Pakistan. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-26.

Sponsored by Dow University of Health Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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).

Read the detailed 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).

02

Conditions studied

  • Dentin Sensitivity
  • Hypersensitivity
  • Cervical Lesion

Keywords

  • Dentin Sensitivity
  • Lasotronix
  • Diode laser
03

In context

Dentin Sensitivity

288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.

This study's planned enrollment of 120 is above the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Dow University of Health Sciences is the lead sponsor of 179 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Active Comparator

    would include patients (n=30) who will be given CPP-ACP paste application only

    Other: Active comparator

  • Experimental
    Experimental

    would consist of patients (n=30) who will be given diode laser therapy only

    Device: Experimental group

  • Other
    Combination

    would include patients (n=30) who will be given a combination of CPP-ACP paste \& Laser therapy.

    Combination Product: Combination of laser and paste

  • Other
    Control

    would be a control group

    Behavioral: Control group

Interventions

  • OtherActive comparator

    CPP-ACP paste will be applied on exposed area

  • DeviceExperimental group

    Lasotronix will be applied following its protocol

  • Combination productCombination of laser and paste

    Drug page: Cycloxydim

    This group will receive the combination of above two treatments

  • BehavioralControl group

    this will be a control group

06

What researchers measure

Primary outcomes

  1. treatment of dentin hypersensitivity

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

    Time frame: 0-3 moths

07

Study locations

1 of 1 sites recruiting
  • Dr Sanam Faheem
    Karachi, Sindh 75330, Pakistan
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06463938
Responsible party
Sanam Faheem (Senior Lecturer, Dow University of Health Sciences) — Principal investigator
First posted
Jun 18, 2024
Start date
May 12, 2024
Primary completion
Aug 10, 2024 (estimated)
Completion
Oct 10, 2024 (estimated)
Last update
Jul 26, 2024

Study contacts

Sanam Dr Faheem, MSc
Contact
sanam.faheem@duhs.edu.pk
021-38771000
Chandar Dr Kumar
Contact
chander.kumar@duhs.edu.pk
021-38771000

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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