Dentinal HypersensitivityLaser & BioactNCT07396610
Effect of Diode Laser and Bioactive Glass on Dentinal Hypersensitivity
A study testing 810-nm Diode Laser and Bioactive Glass (NovaMin) in people with Dentinal Hypersensitivity, run by King Khalid University at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dentinal Hypersensitivity
- What is being tested?
- 810-nm Diode Laser and Bioactive Glass (NovaMin)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2025to 30 Nov 2025
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of a Bioactive Glass Dentifrice and 810 nm Diode Laser for Dentinal Hypersensitivity: A Randomized Placebo-Controlled Clinical Study
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.
Read the detailed description
Dentinal hypersensitivity is a frequently encountered clinical condition characterized by a short, sharp pain arising from exposed dentin in response to thermal, tactile, osmotic, or evaporative stimuli. The condition is commonly associated with gingival recession, enamel loss, or dentin exposure due to abrasion, erosion, or periodontal therapy. Despite its high prevalence, the management of dentinal hypersensitivity remains challenging, and no single treatment approach has been universally accepted as the gold standard.
Conventional management strategies are primarily based on either neural desensitization or occlusion of dentinal tubules. Bioactive glass-based desensitizing agents, such as those containing calcium sodium phosphosilicate, act by releasing calcium and phosphate ions that form a hydroxycarbonate apatite-like layer, leading to physical occlusion of dentinal tubules. In contrast, diode laser therapy has been proposed to reduce dentinal hypersensitivity through mechanisms that may include alteration of nerve conduction, coagulation of dentinal proteins, and partial sealing of dentinal tubules. However, the comparative clinical effectiveness and durability of these treatment modalities remain unclear, particularly over long-term follow-up periods.
This randomized controlled clinical trial is designed to compare the effects of an 810-nm diode laser, a bioactive glass-based desensitizing agent, and a placebo intervention in the management of dentinal hypersensitivity. Eligible participants diagnosed with dentinal hypersensitivity based on clinical examination and positive response to standardized air stimulus testing will be randomly allocated into three parallel treatment groups. Randomization will be performed using an appropriate allocation method to ensure balanced group distribution.
Participants in the diode laser group will receive non-contact laser irradiation applied to exposed dentin surfaces using an 810-nm diode laser at a standardized power setting and exposure duration. Participants in the bioactive glass group will receive topical application of a bioactive glass-containing desensitizing agent according to manufacturer-recommended instructions. The placebo group will receive an inactive intervention designed to mimic the appearance and application procedure of the active treatments without containing therapeutic components.
Pain intensity will be assessed using a visual analog scale following standardized air stimulus testing. Outcome assessments will be conducted at baseline, immediately after treatment, and during follow-up visits at 1 month, 6 months, and 12 months. The primary outcome measure will be the change in dentinal hypersensitivity pain scores from baseline. Secondary outcomes will include the sustainability of pain reduction and participant-reported comfort over time.
All clinical procedures and assessments will be performed by trained personnel following standardized protocols to minimize variability. Ethical approval will be obtained from the appropriate institutional review board or ethics committee prior to study initiation, and written informed consent will be obtained from all participants. The results of this study are intended to provide clinically relevant evidence regarding the comparative performance of diode laser therapy and bioactive glass-based desensitizing agents for the management of dentinal hypersensitivity.
- Conditions
- Dentinal Hypersensitivity
- Being tested
- 810-nm Diode Laser, Bioactive Glass (NovaMin), Placebo
- Keywords
- Dentinal Hypersensitivity, Diode Laser, 810-nm Diode Laser, Bioactive Glass, Desensitizing Agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
810-nm Diode LaserDevice
Non-contact diode laser irradiation applied to exposed dentin
Bioactive Glass (NovaMin)Drug
Topical application of bioactive glass-containing desensitizing agent
PlaceboOther
Inactive material resembling test interventions.
| Study group | Role | What they receive |
|---|---|---|
| Diode Laser Group | Experimental | Participants receive 810-nm diode laser therapy applied to hypersensitive dentin. Receives: Device: 810-nm Diode Laser |
| Bioactive Glass Group | Experimental | Participants receive a bioactive glass-based desensitizing agent applied to hypersensitive dentin Receives: Drug: Bioactive Glass (NovaMin) |
| Placebo Group | Placebo comparator | Participants receive a placebo intervention without active desensitizing properties. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately after treatment, 1 month, 6 months, and 12 months
Secondary outcomes (2)
Sustained Reduction in Dentinal Hypersensitivity
Assessment of long-term changes in dentinal hypersensitivity pain scores measured using a visual analog scale (VAS) following standardized air stimulus testing.
Measured: 6 months and 12 months
Participant-Reported Comfort Level
Participant-reported perception of comfort and sensitivity related to the treated tooth, recorded using a structured questionnaire.
Measured: 1 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Jan 2025
- Primary completion30 Mar 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentinal HypersensitivityStudies 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
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Khalid University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunil Kumar Vaddamanu, King Khalid University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396610
- Sponsor's protocol ID
- SRGCDS/2024/044
- Other IDs
- RGP1/3/46
- Acronym
- Laser & Bioact
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly. The dataset contains sensitive clinical and personal information, and participant consent does not include provisions for public data sharing. De-identified aggregate data will be reported through publications and trial registry results in accordance with ethical approvals and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of a Bioactive Glass Dentifrice and 810 nm Diode Laser for Dentinal Hypersensitivity: A Randomized Placebo-Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07396610
- Acronym / sponsor ID
- Laser & Bioact / SRGCDS/2024/044
- Conditions
- Dentinal Hypersensitivity
- Keywords
- Dentinal Hypersensitivity, Diode Laser, 810-nm Diode Laser, Bioactive Glass, Desensitizing Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- King Khalid UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 9 Feb 2026 (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.
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.
Detailed description
Dentinal hypersensitivity is a frequently encountered clinical condition characterized by a short, sharp pain arising from exposed dentin in response to thermal, tactile, osmotic, or evaporative stimuli. The condition is commonly associated with gingival recession, enamel loss, or dentin exposure due to abrasion, erosion, or periodontal therapy. Despite its high prevalence, the management of dentinal hypersensitivity remains challenging, and no single treatment approach has been universally accepted as the gold standard.
Conventional management strategies are primarily based on either neural desensitization or occlusion of dentinal tubules. Bioactive glass-based desensitizing agents, such as those containing calcium sodium phosphosilicate, act by releasing calcium and phosphate ions that form a hydroxycarbonate apatite-like layer, leading to physical occlusion of dentinal tubules. In contrast, diode laser therapy has been proposed to reduce dentinal hypersensitivity through mechanisms that may include alteration of nerve conduction, coagulation of dentinal proteins, and partial sealing of dentinal tubules. However, the comparative clinical effectiveness and durability of these treatment modalities remain unclear, particularly over long-term follow-up periods.
This randomized controlled clinical trial is designed to compare the effects of an 810-nm diode laser, a bioactive glass-based desensitizing agent, and a placebo intervention in the management of dentinal hypersensitivity. Eligible participants diagnosed with dentinal hypersensitivity based on clinical examination and positive response to standardized air stimulus testing will be randomly allocated into three parallel treatment groups. Randomization will be performed using an appropriate allocation method to ensure balanced group distribution.
Participants in the diode laser group will receive non-contact laser irradiation applied to exposed dentin surfaces using an 810-nm diode laser at a standardized power setting and exposure duration. Participants in the bioactive glass group will receive topical application of a bioactive glass-containing desensitizing agent according to manufacturer-recommended instructions. The placebo group will receive an inactive intervention designed to mimic the appearance and application procedure of the active treatments without containing therapeutic components.
Pain intensity will be assessed using a visual analog scale following standardized air stimulus testing. Outcome assessments will be conducted at baseline, immediately after treatment, and during follow-up visits at 1 month, 6 months, and 12 months. The primary outcome measure will be the change in dentinal hypersensitivity pain scores from baseline. Secondary outcomes will include the sustainability of pain reduction and participant-reported comfort over time.
All clinical procedures and assessments will be performed by trained personnel following standardized protocols to minimize variability. Ethical approval will be obtained from the appropriate institutional review board or ethics committee prior to study initiation, and written informed consent will be obtained from all participants. The results of this study are intended to provide clinically relevant evidence regarding the comparative performance of diode laser therapy and bioactive glass-based desensitizing agents for the management of dentinal hypersensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diode Laser Group | Experimental | Device: 810-nm Diode LaserParticipants receive 810-nm diode laser therapy applied to hypersensitive dentin. |
| Bioactive Glass Group | Experimental | Drug: Bioactive Glass (NovaMin)Participants receive a bioactive glass-based desensitizing agent applied to hypersensitive dentin |
| Placebo Group | Placebo comparator | Other: PlaceboParticipants receive a placebo intervention without active desensitizing properties. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| 810-nm Diode LaserNon-contact diode laser irradiation applied to exposed dentin | Device | Diode Laser Group |
| Bioactive Glass (NovaMin)Topical application of bioactive glass-containing desensitizing agent | Drug | Bioactive Glass Group |
| PlaceboInactive material resembling test interventions. | Other | Placebo Group |
Primary outcome
Change in Dentinal Hypersensitivity Pain Score
Time frame: Baseline, immediately after treatment, 1 month, 6 months, and 12 months
Change in pain intensity associated with dentinal hypersensitivity measured using a visual analog scale (VAS) following standardized air stimulus testing on the affected tooth.
2 secondary outcomes
Sustained Reduction in Dentinal Hypersensitivity
Time frame: 6 months and 12 months
Participant-Reported Comfort Level
Time frame: 1 month and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly. The dataset contains sensitive clinical and personal information, and participant consent does not include provisions for public data sharing. De-identified aggregate data will be reported through publications and trial registry results in accordance with ethical approvals and institutional policies.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 810-nm Diode Laser and Bioactive Glass (NovaMin) in people with Dentinal Hypersensitivity, run by King Khalid University at 1 site in India.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 9 Feb 2026. 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 India. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dentinal Hypersensitivity Pain Score (time frame: Baseline, immediately after treatment, 1 month, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2026.