Diode Laser Plus CPP-ACPF vs CPP-ACPF Alone for Dentin Hypersensitivity

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dentin Hypersensitivity; Tooth Hypersensitivity
• Intervention / Treatment: Device: Diode laser photobiomodulation combined with CPP-ACPF varnish; Other: CPP-ACPF varnish

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariam M Mohamed, Master's candidate; Phone Number: +20 100 088 2942; Email: mariam.kamal@dentistry.cu.edu.eg
• Study Contact Backup: Name: Mona M Eissa; Email: monamahmoud@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A - Diode Laser + CPP-ACPF; Participants will receive diode laser treatment combined with CPP-ACPF varnish on sensitive teeth.	Device: Diode laser photobiomodulation combined with CPP-ACPF varnish; Participants will receive diode laser photobiomodulation applied to sensitive teeth followed by application of CPP-ACPF varnish according to the manufacturer's instructions. This combination treatment is intended to reduce dentin hypersensitivity.; Other Names: Low-level laser therapy (LLLT); photobiomodulation; PBM; Diode laser therapy
Active Comparator: Group B - CPP-ACPF Varnish Alone; Participants will receive CPP-ACPF varnish alone on sensitive teeth.	Other: CPP-ACPF varnish; Participants will receive CPP-ACPF varnish applied to sensitive teeth according to the manufacturer's instructions to reduce dentin hypersensitivity.; Other Names: Casein phosphopeptide-amorphous calcium phosphate fluoride varnish

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in dentin hypersensitivity in response to evaporative (air-blast) stimulus	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".	Assessed at baseline, immediately post-treatment, and at 1 month, 3 months, and 6 months follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in dentin hypersensitivity in response to tactile (dental probe) stimulus.	Change in dentin hypersensitivity in response to a tactile stimulus using a dental probe, measured with a visual analog scale (VAS). Lower scores indicate reduced sensitivity. Scores: 0-10 (Ordinal) where 0 represents "no pain" and 10 represents "greatest pain".	Assessed at baseline, immediately post-treatment, and at 1 month, 3 months, and 6 months follow-up.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: photobiomodulation; diode laser; dentin hypersensitivity; Desensitizing treatment; Non-carious cervical lesions; tooth hypersensitivity; CPP-ACPF varnish; Dental laser treatment
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dentin Sensitivity; Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: Cons-DH-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No