Comparative Efficacy of Diode Laser Photobiomodulation Combined With CPP-ACPF Varnish Versus CPP-ACPF Varnish Alone in the Management of Dentin Hypersensitivity: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 70
- Primary Endpoint
- Reduction in dentin hypersensitivity in response to evaporative (air-blast) stimulus
Overview
Brief Summary
This study aims to compare the effectiveness of diode laser photobiomodulation combined with CPP-ACPF varnish versus CPP-ACPF varnish alone in reducing dentin hypersensitivity. Participants diagnosed with dentin hypersensitivity will receive either the combined treatment or varnish application alone. Pain levels will be evaluated using a standardized visual analog scale before and after treatment sessions. The results of this study may help determine whether adding diode laser therapy enhances the effectiveness of conventional varnish treatment in managing dentin hypersensitivity.
Detailed Description
This study is a clinical trial designed to evaluate the effectiveness of two treatments for dentin hypersensitivity, which is the pain or discomfort felt when teeth are exposed to hot, cold, sweet, or touch.
Participants who meet the study criteria will be randomly assigned to one of two groups:
Group A: Treatment with a diode laser combined with CPP-ACPF varnish applied to the sensitive teeth.
Group B: Treatment with CPP-ACPF varnish alone.
Study Procedures:
Screening and Enrollment: Participants will undergo a dental examination to confirm they have sensitive teeth. Medical history and consent will be collected.
Baseline Assessment: Pain sensitivity will be measured using a simple pain scale to record how severe the sensitivity is before treatment.
Treatment: The assigned treatment will be applied to the sensitive teeth. The laser procedure is painless and safe, and the varnish is a commonly used dental material.
Follow-Up Visits: Participants will return for follow-up assessments immediately after treatment, after one month, after three months, and after six months. Pain sensitivity will be measured at each visit to track changes over time.
Safety and Monitoring:
The procedures are safe, and side effects are expected to be minimal.
Any discomfort or unexpected reactions will be addressed promptly by the dental team.
Participants can withdraw from the study at any time without affecting their standard dental care.
Purpose of the Study:
The goal is to determine whether combining diode laser treatment with CPP-ACPF varnish is more effective at reducing tooth sensitivity than using the varnish alone. The results may help dentists provide the best treatment options for patients with sensitive teeth in the future.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessor and analyst will be blinded to the intervention group assigned to the patients.
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult participants aged from 20 to 50 years of age.
- •Participants with good oral hygiene.
- •Presence of at least one tooth with dentin hypersensitivity confirmed by the air blast and/or tactile stimuli (scoring ≥3 on the VAS).
- •Participants willing to cooperate and attend recall appointments
- •Teeth with Non-Carious Cervical Lesions.
- •Patients with dentin hypersensitivity due to GERD and Parafunctional habits e.g., bruxism.
- •Patients with dentin hypersensitivity associated with gingival recession.
Exclusion Criteria
- •Participants with poor oral hygiene.
- •History of professional or at-home desensitizing treatment within the previous 3 months.
- •Pregnant or lactating females.
- •Concurrent participation in other research studies.
- •Inability to comply with study procedures.
- •History of allergic reactions to study materials.
- •Medical conditions interfering with pain reporting accuracy (pain disorders, constant use of analgesics, anti-inflammatory, or psychotropic medications).
- •History of periodontal surgeries within the last six months.
- •Periodontitis and pulpitis.
Arms & Interventions
Group A - Diode Laser + CPP-ACPF
Participants will receive diode laser treatment combined with CPP-ACPF varnish on sensitive teeth.
Intervention: Diode laser photobiomodulation combined with CPP-ACPF varnish (Device)
Group B - CPP-ACPF Varnish Alone
Participants will receive CPP-ACPF varnish alone on sensitive teeth.
Intervention: CPP-ACPF varnish (Other)
Outcomes
Primary Outcomes
Reduction in dentin hypersensitivity in response to evaporative (air-blast) stimulus
Time Frame: Assessed at baseline, immediately post-treatment, and at 1 month, 3 months, and 6 months follow-up.
Change in dentin hypersensitivity in response to an evaporative (air-blast) stimulus, measured using a visual analog scale (VAS). Lower scores indicate reduced sensitivity. Scores: 0-10 (Ordinal) where 0 represents "no pain" and 10 represents "greatest pain".
Secondary Outcomes
- Reduction in dentin hypersensitivity in response to tactile (dental probe) stimulus.(Assessed at baseline, immediately post-treatment, and at 1 month, 3 months, and 6 months follow-up.)
Investigators
Mariam Mamdouh Mohamed Kamal
Dentist
Cairo University