NCT06463938

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

June 11, 2024

Last Update Submit

July 25, 2024

Conditions

Keywords

Dentin SensitivityLasotronixDiode laser

Outcome Measures

Primary Outcomes (1)

  • treatment of dentin hypersensitivity

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

    0-3 moths

Study Arms (4)

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

Combination

OTHER

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

Combination Product: Combination of laser and paste

Control

OTHER

would be a control group

Behavioral: Control group

Interventions

CPP-ACP paste will be applied on exposed area

Active Comparator

Lasotronix will be applied following its protocol

Experimental

This group will receive the combination of above two treatments

Combination
Control groupBEHAVIORAL

this will be a control group

Control

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Sanam Faheem

Karachi, Sindh, 75330, Pakistan

RECRUITING

MeSH Terms

Conditions

Dentin SensitivityHypersensitivity

Interventions

OintmentsControl Groups

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Sanam Dr Faheem, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 18, 2024

Study Start

May 12, 2024

Primary Completion

August 10, 2024

Study Completion

October 10, 2024

Last Updated

July 26, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Locations