Effect of Diode Laser and Bioactive Glass on Dentinal Hypersensitivity

NCT07396610 | Completed

• 2 other identifiers: SRGCDS/2024/044RGP1/3/46
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Dentinal hypersensitivity is a common clinical condition characterized by short, sharp pain arising from exposed dentin in response to thermal, tactile, or evaporative stimuli. It can significantly affect oral health-related quality of life and routine dental care. Various treatment approaches have been proposed, including laser therapy and bioactive materials, with differing mechanisms of action and clinical outcomes. This randomized controlled clinical trial aims to compare the effectiveness of an 810-nm diode laser, a bioactive glass-based desensitizing agent, and a placebo in reducing dentinal hypersensitivity. Eligible participants with clinically diagnosed dentinal hypersensitivity will be randomly assigned to one of three parallel treatment groups. Pain intensity will be assessed using a visual analog scale following standardized air stimulus testing at baseline and at predefined follow-up intervals. The study will evaluate both immediate and long-term changes in hypersensitivity over a 12-month follow-up period. The findings are intended to provide clinical evidence on the comparative performance of diode laser therapy and bioactive glass in the management of dentinal hypersensitivity.

Conditions

Dentinal Hypersensitivity

Keywords

Dentinal Hypersensitivity; Diode Laser; 810-nm Diode Laser; Bioactive Glass; Desensitizing Agents

Outcome Measures

Primary Outcomes (1)

• Change in Dentinal Hypersensitivity Pain Score

  Change in pain intensity associated with dentinal hypersensitivity measured using a visual analog scale (VAS) following standardized air stimulus testing on the affected tooth.

  Baseline, immediately after treatment, 1 month, 6 months, and 12 months

Secondary Outcomes (2)

• Sustained Reduction in Dentinal Hypersensitivity

  6 months and 12 months

• Participant-Reported Comfort Level

  1 month and 6 months

Study Arms (3)

Diode Laser Group

EXPERIMENTAL

Participants receive 810-nm diode laser therapy applied to hypersensitive dentin.

Device: 810-nm Diode Laser

Bioactive Glass Group

EXPERIMENTAL

Participants receive a bioactive glass-based desensitizing agent applied to hypersensitive dentin

Drug: Bioactive Glass (NovaMin)

Placebo Group

PLACEBO COMPARATOR

Participants receive a placebo intervention without active desensitizing properties.

Other: Placebo

Interventions

810-nm Diode Laser DEVICE

Non-contact diode laser irradiation applied to exposed dentin

Diode Laser Group

Bioactive Glass (NovaMin) DRUG

Topical application of bioactive glass-containing desensitizing agent

Bioactive Glass Group

Placebo OTHER

Inactive material resembling test interventions.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18 to 60 years
• Presence of clinically diagnosed dentinal hypersensitivity in at least one tooth
• Positive response to standardized air stimulus test
• Good general and oral health

You may not qualify if:

• Presence of dental caries, defective restorations, or cracked teeth in the study tooth
• Evidence of pulpal pathology or periapical disease
• Periodontal disease requiring active treatment
• Use of desensitizing agents or sensitivity treatments within the previous 4 weeks
• History of allergy or hypersensitivity to any study materials
• Systemic conditions or medications that may affect pain perception
• Pregnant or lactating women

Sponsors & Collaborators

• King Khalid University: lead

Study Sites (1)

Sri Rajiv Gandhi College of Dental Sciences & Hospital

Bangalore, India

Location

MeSH Terms

Interventions

Lasers, Semiconductor; NovaMin

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to the assigned intervention. The diode laser, bioactive glass application, and placebo procedures are designed to appear similar to participants to minimize expectation bias. Outcome assessments are conducted using standardized protocols.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants with dentinal hypersensitivity are randomly assigned to one of three parallel groups to receive either 810-nm diode laser therapy, a bioactive glass-based desensitizing agent, or a placebo intervention. Each participant receives only the assigned intervention and is followed longitudinally for outcome assessment.

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 9, 2026
• Study Start: January 1, 2025
• Primary Completion: March 30, 2025
• Study Completion: November 30, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)