Dentin SensitivityNCT06463938
A Clinical Trial to Compare Lasotronix Alone or in Combination With CPP-ACP to Treat DH
A study testing Active comparator, Experimental group and Combination of laser and paste in people with Dentin Sensitivity and Hypersensitivity, run by Dow University of Health Sciences at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity, Hypersensitivity, Cervical Lesion
- What is being tested?
- Active comparator, Experimental group and Combination of laser and paste
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 12 May 2024to 10 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Dr Sanam Faheem
Karachi, Sindh, 75330
Sanam Dr Faheem, MSC, 021-38771000, sanam.faheem@duhs.edu.pk
About this study
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
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).
- Conditions
- Dentin Sensitivity, Hypersensitivity, Cervical Lesion
- Being tested
- Active comparator, Experimental group, Combination of laser and paste, Control group
- Keywords
- Dentin Sensitivity, Lasotronix, Diode laser
- Medical subject headings
- Dentin Sensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active comparatorOther
CPP-ACP paste will be applied on exposed area
Experimental groupDevice
Lasotronix will be applied following its protocol
Combination of laser and pasteCombination product
This group will receive the combination of above two treatments
Control groupBehavioural
this will be a control group
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | would include patients (n=30) who will be given CPP-ACP paste application only Receives: Other: Active comparator |
| Experimental | Experimental | would consist of patients (n=30) who will be given diode laser therapy only Receives: Device: Experimental group |
| Combination | Other | would include patients (n=30) who will be given a combination of CPP-ACP paste \& Laser therapy. Receives: Combination Product: Combination of laser and paste |
| Control | Other | would be a control group Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment of dentin hypersensitivity
VAS Visual analogue scale will be used to determine the efficacy of different treatment methods.
Measured: 0-3 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start12 May 2024
- Primary completion10 Aug 2024 (estimated)
- Study completion10 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dentin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanam Faheem, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463938
- Sponsor's protocol ID
- Dow
- Status last verified
- Jul 2024
- First submitted
- 11 Jun 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Faheem S, Qasim R, Kumar C, Farooqui WA, Rehman A, Maqsood S, Sahito MA, Kumar N, Zafar MS. Casein Phosphopeptide and Diode Laser in Treating Dentin Hypersensitivity: A Clinical Study. J Lasers Med Sci. 2025 Dec 8;16:e64. doi: 10.34172/jlms.2025.64. eCollection 2025.
PubMed 41789288
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06463938
- Acronym / sponsor ID
- Dow
- Conditions
- Dentin Sensitivity, Hypersensitivity, Cervical Lesion
- Keywords
- Dentin Sensitivity, Lasotronix, Diode laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 12 May 2024 (actual)
- Primary completion
- 10 Aug 2024 (estimated)
- Study completion
- 10 Oct 2024 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Other: Active comparatorwould include patients (n=30) who will be given CPP-ACP paste application only |
| Experimental | Experimental | Device: Experimental groupwould consist of patients (n=30) who will be given diode laser therapy only |
| Combination | Other | Combination Product: Combination of laser and pastewould include patients (n=30) who will be given a combination of CPP-ACP paste \& Laser therapy. |
| Control | Other | Behavioral: Control groupwould be a control group |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active comparatorCPP-ACP paste will be applied on exposed area | Other | Active Comparator |
| Experimental groupLasotronix will be applied following its protocol | Device | Experimental |
| Combination of laser and pasteThis group will receive the combination of above two treatments | Combination product | Combination |
| Control groupthis will be a control group | Behavioural | Control |
Primary outcome
treatment of dentin hypersensitivity
Time frame: 0-3 moths
VAS Visual analogue scale will be used to determine the efficacy of different treatment methods.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Derived from this study: PubMed 41789288Faheem S, Qasim R, Kumar C, Farooqui WA, Rehman A, Maqsood S, Sahito MA, Kumar N, Zafar MS. Casein Phosphopeptide and Diode Laser in Treating Dentin Hypersensitivity: A Clinical Study. J Lasers Med Sci. 2025 Dec 8;16:e64. doi: 10.34172/jlms.2025.64. eCollection 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active comparator, Experimental group and Combination of laser and paste in people with Dentin Sensitivity and Hypersensitivity, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanam Dr Faheem, MSc (021-38771000, sanam.faheem@duhs.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment of dentin hypersensitivity (time frame: 0-3 moths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06463938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.