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

NCT ID: NCT06463938

Last Updated: 2024-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-12

Study Completion Date

2024-10-10

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Dentin Sensitivity Hypersensitivity Cervical Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active Comparator

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

Group Type ACTIVE_COMPARATOR

Active comparator

Intervention Type OTHER

CPP-ACP paste will be applied on exposed area

Experimental

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

Group Type EXPERIMENTAL

Experimental group

Intervention Type DEVICE

Lasotronix will be applied following its protocol

Combination

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

Group Type OTHER

Combination of laser and paste

Intervention Type COMBINATION_PRODUCT

This group will receive the combination of above two treatments

Control

would be a control group

Group Type OTHER

Control group

Intervention Type BEHAVIORAL

this will be a control group

Interventions

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Active comparator

CPP-ACP paste will be applied on exposed area

Intervention Type OTHER

Experimental group

Lasotronix will be applied following its protocol

Intervention Type DEVICE

Combination of laser and paste

This group will receive the combination of above two treatments

Intervention Type COMBINATION_PRODUCT

Control group

this will be a control group

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Sanam Faheem

Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr Sanam Faheem

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Sanam Dr Faheem, MSc

Role: CONTACT

021-38771000

Chandar Dr Kumar

Role: CONTACT

021-38771000

Facility Contacts

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Sanam Dr Faheem, MSC

Role: primary

021-38771000

Other Identifiers

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Dow

Identifier Type: -

Identifier Source: org_study_id

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