Sensitivity, ToothNCT04248803

Evaluation of Gluma Desensitizer in Post-treatment Sensitivity in Posterior Composite

A study testing GLUMA (Kulzer GmbH, Germany) desensitizing agent in people with Sensitivity, Tooth, run by Tamil Nadu Dr.M.G.R.Medical University at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the effect of Gluma desensitizer in controlling immediate post-treatment sensitivity in posterior occlusal composite restorations. Read more about this study

Who is it for?: Ages 15 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Sensitivity, Tooth
What is being tested?: GLUMA (Kulzer GmbH, Germany) desensitizing agent
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 570 participants
Where: 1 siteIndia
Study dates: 6 Feb 2020to 20 Feb 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 15 to 70 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Occlusal cavitated caries in maxillary and mandibular first and second molars

Who cannot join

Occlusal caries with axial or proximal extension
Teeth with periodontal treatment within last three months
Teeth with cracks
Teeth to be taken as abutment for prosthesis
Patients with psychiatric treatment
Patients in orthodontic treatment or going to need orthodontic treatment

Show all 10Show fewer

Patients under dentin hypersensitivity or using desensitizer treatment
Patients not willing for post treatment follow up
Patients having any other teeth with pain or sensitivity symptoms
Caries excavation with pulp exposure and post treatment sensitivity due to occusal interference in restoration

Trial locations and contacts

1 site in 1 country.

India1 site

CSI College of Dental Sciences and Research
Madurai, Tamil Nadu, 625 001

Other trials in India

About this study

Official title: Efficacy of Gluma Desensitizer in Controlling the Immediate Post-treatment Sensitivity in Etch-and-rinse and Self-etch Adhesive Bonded Occlusal Composite Restorations

To evaluate the effect of Gluma desensitizer in controlling immediate post-treatment sensitivity in posterior occlusal composite restorations.

Read the detailed description

The primary objective of this study is to observe the effect of gluma desensitizer application in controlling the post-treatment sensitivity in posterior occlusal composite restoration in molar teeth using 2 adhesive bonding strategies.

The secondary objective is to evaluate the difference in the post-treatment sensitivity on application of Gluma desensitizer either prior to or after acid etching.

The different adhesive gluma desensitizer application groups are randomly divided into 6 groups,

Total etch control group (No gluma desensitizer application)
Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching
Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching
Self etch control group (No gluma desensitizer application)
Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching
Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching

Conditions: Sensitivity, Tooth
Being tested: GLUMA (Kulzer GmbH, Germany) desensitizing agent
Medical subject headings: Dentin Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GLUMA (Kulzer GmbH, Germany) desensitizing agentOther
GLUMA desensitizer is used to reduce tooth sensitivity

Study groups in NCT04248803
Study group	Role	What they receive
Total etch control group	No intervention	No gluma desensitizer application
TE - GLUMA application prior to acid etching	Experimental	TE- Total Etch GLUMA - Desensitizing agent Receives: Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent
TE - GLUMA application after acid etching	Experimental	TE- Total Etch GLUMA - Desensitizing agent Receives: Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent
Self etch control group	No intervention	No gluma desensitizer application
SE - GLUMA application prior to acid etching	Experimental	SE - Self Etch GLUMA - Desensitizing agent Receives: Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent
SE - GLUMA application after acid etching	Experimental	SE - Self Etch GLUMA - Desensitizing agent Receives: Other: GLUMA (Kulzer GmbH, Germany) desensitizing agent

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Post-operative Sensitivity Having VAS Score >3
post-operative sensitivity is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
Measured: 24 hours
Number of Participants With Post-operative Sensitivity Having VAS Score >3
post-operative sensitivity is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
Measured: 48 hours
Number of Participants With Post-operative Sensitivity Having VAS Score >3
post-operative sensitivity is evaluated using Visual Analog Scale(VAS) and cold spray VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
Measured: 1 week

Secondary outcomes (3)

Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3
post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
Measured: 24 hours
Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3
post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
Measured: 48 hours
Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3
post-operative sensitivity is either due to stimulus or spontaneous is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Feb 202020 Feb 2025

First posted30 Jan 2020
Study start6 Feb 2020
Primary completion20 Feb 2025
Study completion20 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sensitivity, ToothStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 570 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04248803
Sponsor's protocol ID: CSICDSR
Status last verified: Sep 2025
First submitted: 28 Jan 2020
Last updated: 20 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
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Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
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Nano Silver Fluoride and Photobiomodulation Therapy for Hypersensitivity and Pain in MIH-Affected Molars
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All Sensitivity, Tooth trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Gluma Desensitizer in Controlling the Immediate Post-treatment Sensitivity in Etch-and-rinse and Self-etch Adhesive Bonded Occlusal Composite Restorations
ClinicalTrials.gov ID: NCT04248803
Acronym / sponsor ID: CSICDSR
Conditions: Sensitivity, Tooth
Study type: Interventional
Recruitment status: Completed
Enrolment: 570 participants (actual)
Lead sponsor: Tamil Nadu Dr.M.G.R.Medical UniversityUniversity, hospital or other
Study start: 6 Feb 2020 (actual)
Primary completion: 20 Feb 2025 (actual)
Study completion: 20 Feb 2025 (actual)
First posted: 30 Jan 2020 (actual)
Results: Posted 20 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the effect of Gluma desensitizer in controlling immediate post-treatment sensitivity in posterior occlusal composite restorations.

Detailed description

The secondary objective is to evaluate the difference in the post-treatment sensitivity on application of Gluma desensitizer either prior to or after acid etching.

The different adhesive gluma desensitizer application groups are randomly divided into 6 groups,

Total etch control group (No gluma desensitizer application)
Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching
Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching
Self etch control group (No gluma desensitizer application)
Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching
Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Total etch control group	No intervention	–No gluma desensitizer application
TE - GLUMA application prior to acid etching	Experimental	Other: GLUMA (Kulzer GmbH, Germany) desensitizing agentTE- Total Etch GLUMA - Desensitizing agent
TE - GLUMA application after acid etching	Experimental	Other: GLUMA (Kulzer GmbH, Germany) desensitizing agentTE- Total Etch GLUMA - Desensitizing agent
Self etch control group	No intervention	–No gluma desensitizer application
SE - GLUMA application prior to acid etching	Experimental	Other: GLUMA (Kulzer GmbH, Germany) desensitizing agentSE - Self Etch GLUMA - Desensitizing agent
SE - GLUMA application after acid etching	Experimental	Other: GLUMA (Kulzer GmbH, Germany) desensitizing agentSE - Self Etch GLUMA - Desensitizing agent

Who may qualify

Ages: 15 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Occlusal cavitated caries in maxillary and mandibular first and second molars

Key exclusion criteria (10 listed)

Occlusal caries with axial or proximal extension
Teeth with periodontal treatment within last three months
Teeth with cracks
Teeth to be taken as abutment for prosthesis
Patients with psychiatric treatment

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
GLUMA (Kulzer GmbH, Germany) desensitizing agentGLUMA desensitizer is used to reduce tooth sensitivity	Other	SE - GLUMA application after acid etching, SE - GLUMA application prior to acid etching, TE - GLUMA application after acid etching, TE - GLUMA application prior to acid etching

Primary outcome

Number of Participants With Post-operative Sensitivity Having VAS Score >3
Time frame: 24 hours
post-operative sensitivity is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
Number of Participants With Post-operative Sensitivity Having VAS Score >3
Time frame: 48 hours
post-operative sensitivity is evaluated using Visual Analog Scale(VAS) VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe
Number of Participants With Post-operative Sensitivity Having VAS Score >3
Time frame: 1 week
post-operative sensitivity is evaluated using Visual Analog Scale(VAS) and cold spray VAS rating Score (1 to 10): 1-3: Mild, 4-6:Moderate,7-10:Severe

3 secondary outcomes

Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3
Time frame: 24 hours
Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3
Time frame: 48 hours
Number of Participants With Stimulus Based/ Spontaneous Post-operative Sensitivity Having VAS Score >3
Time frame: 1 week

Results and safety

Results posted to the registry on 20 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Total Etch (TE) Control Group	91	84
TE - GLUMA Application After Acid Etching	91	84
TE - GLUMA Application Prior to Acid Etching	91	84
Self Etch (SE) Control Group	91	84
SE - GLUMA Application Prior to Acid Etching	91	84
SE - GLUMA Application After Acid Etching	91	84

Primary outcome: Number of Participants With Post-operative Sensitivity Having VAS Score >3

Time frame: 24 hours. Count of participants. Unit: Participants

Measure	Total Etch (TE) Control Group n = 84	TE - GLUMA Application After Acid Etching n = 84	TE - GLUMA Application Prior to Acid Etching n = 84	Self Etch (SE) Control Group n = 84	SE - GLUMA Application Prior to Acid Etching n = 84	SE - GLUMA Application After Acid Etching n = 84
Value	14	12	6	16	15	21

Total Etch (TE) Control Group vs TE - GLUMA Application After Acid Etching vs TE - GLUMA Application Prior to Acid Etching vs Self Etch (SE) Control Group vs SE - GLUMA Application Prior to Acid Etching vs SE - GLUMA Application After Acid Etching: p = 0.05, Kruskal-Wallis

Population analysed: 84 participants in each group were analyzed for post operative sensitivity using visual analogue scale (VAS) ranging from 1 -10 at the end of 24 hours.

Primary outcome: Number of Participants With Post-operative Sensitivity Having VAS Score >3

Time frame: 48 hours. Count of participants. Unit: Participants

Measure	Total Etch (TE) Control Group n = 84	TE - GLUMA Application After Acid Etching n = 84	TE - GLUMA Application Prior to Acid Etching n = 84	Self Etch (SE) Control Group n = 84	SE - GLUMA Application Prior to Acid Etching n = 84	SE - GLUMA Application After Acid Etching n = 84
Value	14	12	6	13	4	11

Population analysed: 84 participants in each group were analyzed for post operative sensitivity using VAS ranging from 1 - 10 at the end of 48 hours

Primary outcome: Number of Participants With Post-operative Sensitivity Having VAS Score >3

Time frame: 1 week. Count of participants. Unit: Participants

Measure	Total Etch (TE) Control Group n = 84	TE - GLUMA Application After Acid Etching n = 84	TE - GLUMA Application Prior to Acid Etching n = 84	Self Etch (SE) Control Group n = 84	SE - GLUMA Application Prior to Acid Etching n = 84	SE - GLUMA Application After Acid Etching n = 84
Value	6	12	3	9	2	12

Population analysed: 84 participants in each group were analyzed for post operative sensitivity using VAS ranging from 1 - 10 at the end of 1 week

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study began enrolling participants from February 6, 2020 to February 20, 2025. The adverse events were thoroughly examined for each participant who was enrolled in this clinical trial started from their baseline period at the end of 24 hours till their final visit at the end of 1 week. The last participant was recruited on February 13, 2025 and adverse events were examined with the study completion on February 20, 2025. The adverse events time frame for this study would be "1 Week".. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Total Etch Control Group	0 of 84 (0%)	0 of 84 (0%)	0 of 84
TE - GLUMA Application Prior to Acid Etching	0 of 84 (0%)	0 of 84 (0%)	0 of 84
TE - GLUMA Application After Acid Etching	0 of 84 (0%)	0 of 84 (0%)	0 of 84
Self Etch Control Group	0 of 84 (0%)	0 of 84 (0%)	0 of 84
SE - GLUMA Application Prior to Acid Etching	0 of 84 (0%)	0 of 84 (0%)	0 of 84
SE - GLUMA Application After Acid Etching	0 of 84 (0%)	0 of 84 (0%)	0 of 84

Limitations and caveats (from the sponsor): 1. Limited generalizability owing to similar ethnicity and race among all the study participants. 2. Limited reliability of subjective scales such as VAS.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Sensitivity, Tooth

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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.

GEETH DEEPIKA, MDS principal investigator

TN MGR MEDICAL UNIVERSITY

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GLUMA (Kulzer GmbH, Germany) desensitizing agent in people with Sensitivity, Tooth, run by Tamil Nadu Dr.M.G.R.Medical 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 1 inclusion and 10 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 20 Oct 2025. 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. 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?

Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Post-operative Sensitivity Having VAS Score >3 (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 NCT04248803.

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 20 Oct 2025.