Efficacy of Gluma Desensitizer in Controlling the Immediate Post-treatment Sensitivity in Etch-and-rinse and Self-etch Adhesive Bonded Occlusal Composite Restorations
Phase: NA
Conditions: Sensitivity, Tooth
Sponsor: Tamil Nadu Dr.M.G.R.Medical University

 
 
 
 
 
COVER PAGE 
Official title of the study: Efficacy of Gluma desensitizer in 
controlling the immediate post treatment sensitivity in etch-and-
rinse and self-etch adhesive occlusal composite restorations 
NCT04248803  
Date of the document: 02-09-2025 
 
 
 
 
 
 
 

Efficacy of Gluma desensitizer in controlling the immediate post treatment 
sensitivity in etch-and-rinse and self-etch adhesive occlusal composite 
restorations 
NCT04248803  
BRIEF SUMMARY  
Background 
One of the most widely used esthetic restorations in dentistry is composite. Despite the indispensable value 
that composite brings to a dentist’s arsenal, the postoperative sensitivity following composite resin 
restorations are an undesirable outcome often leading to patient discomfort. 
GLUMA desensitizer, a solution containing glutaraldehyde and hydroxyethyl methacrylate (HEMA), is 
widely used to reduce sensitivity by occluding dentinal tubules and stabilizing collagen fibrils. However, the 
ideal timing of GLUMA application in different adhesive protocols remains uncertain, raising questions 
about its effect on postoperative sensitivity, adhesive bond strength, and long-term restoration success. 
This clinical trial aims to evaluate the effectiveness of GLUMA in controlling the immediate post treatment 
sensitivity following occlusal composite restorations. In addition, to compare the difference between the 
bonding systems (Etch-and-rinse & Self-etch) on reduction of post restoration sensitivity with or without 
Gluma desensitizer. 
Sample Size, Blinding and Randomization  
For this clinical trial, a sample size of 504 restorations was calculated to be sufficient for detecting statistical 
difference using G* power software (α probability error – 0.05 and effect size – 0.2).    
 

In this single-blinded clinical trial, the numbers of arms were randomly assigned to six groups. The 
participants of the study were informed about the trial but were unaware of which treatment group they were 
allocated to. The clinician and researcher were aware of the groups and treatments given. All patients were 
allocated using Block randomization. It works by dividing participants into individual blocks and then 
randomly assigning treatments within each block, ensuring roughly equal numbers in each group within that 
block. In this clinical trial, a block size of 6 (1, 2, 3, 4, 5, 6) was employed for equal enrolment. The 
prepared blocks were printed in sheets and patients who met the eligibility criteria were systematically 
assigned in a continuous fashion. After every 6th patient, the enrolment would continue on to the next block 
from 1.  
Arms (n=84 in each) 
Arm 1: Total Etch Control group (No desensitizer application) 
Arm 2: Total Etch Gluma prior to acid etchant usage 
Arm 3: Total Etch Gluma desensitizer application after acid etchant usage 
 Arm 4: Self Etch Control group (No desensitizer application) 
Arm 5: Self Etch Gluma desensitizer application prior to etching 
Arm 6: Self Etch Gluma desensitizer application after self-etch adhesive usage 
Materials and Methodology 
Caries excavation was done using diamond burs (Mani Co., Tochigi, Japan) with water coolant. Cavity 
extent was until sound hard or firm discolored or non-discolored dentin was achieved. This was cross-
checked by an Experienced Post Graduate Supervisor (EPGS) blinded to treatment allocation group. 
Those teeth with width of the cavity preparation were no more than 1/3rd of the inter-cuspal width were 
included. Radiographs (Durr PSP Sensor, Durr, Germany) are taken to assess the depth of the 

preparation and Remaining Dentin Thickness (RDT). Two RDT measurements from mesial and distal 
pulp horn to floor of the preparation were calculated. Mean RDT was derived from the two readings. 
Radiograph assessment was done by EPGS. Teeth were excluded from the study if they had pulp 
exposure or a prepared cavity that did not meet standardization requirements.  
The primary outcome of this clinical trial is to evaluate the effectiveness of GLUMA in controlling the 
immediate post treatment sensitivity following occlusal composite restorations. Hence, all the patients 
were assessed for post restoration sensitivity after 24 hours, 48 hours and at the end of one week. The 
secondary outcome was to assess whether patient had post-operative sensitivity due to any trigger 
stimulus. This was also assessed at the end of 24 hours, 48 hours and one week post –operatively. 
Post –operative sensitivity and trigger factors (if any) after 24 and 48 hours were assessed with VAS 
score (1- 10) through telephonic call by a resident student who are unaware of the treatment allocation 
group. In this study a 1-10 scale were used and the patient is asked to choose a number ranging from 1 to 
10 based on their sensitivity, with 1 being the least sensitivity and 10 being the most. 
Post–operative sensitivity and trigger factors (if any) after one week were checked by recalling and 
clinically assessing the patients using Schiff cold air sensitivity scale by a blinded EPGS. 
Statistical Analysis 
Data was assessed (IBM SPSS Version 23, USA) for normality using the Shapiro-Wilk test. Non-
parametric Kruskal-Wallis test and Mann Whitney U test are employed for difference in post treatment 
sensitivity score among the different groups. 
DETAILED DESCRIPTION  
Introduction One of the most widely used esthetic restorations in dentistry is composite. Despite the 
indispensable value that composite brings to a dentist’s arsenal, the postoperative sensitivity following 
composite resin restorations are an undesirable outcome often leading to patient discomfort. 1This sensitivity 

is primarily caused by dentinal fluid movement within exposed tubules, which can be exacerbated by 
adhesive protocols that do not adequately seal the dentin (Pashley et al., 2002)2, micro gaps caused by 
polymerization shrinkage (Loguercio et al., 2004)3, dentin desiccation and bond degradation over time, 
potentially due to matrix metalloproteinase (MMP) activation (Mazzoni A et al., 2015)4. It’s been reported 
that during the first week after placement of Class I posterior composite restorations, 23% of the patients 
experienced post-operative sensitivity.5  
In order to inhibit the enzymatic activity and increase the longevity of the bond, several materials have been 
several materials have been investigated during the last 15 years (i.e. proanthocyanidin, genipin, tannic acid, 
chitosan, carbodiimide, glutaraldehyde, and chlorhexidine 
GLUMA desensitizer, a solution containing glutaraldehyde (GA) and hydroxyethyl methacrylate (HEMA), 
is widely used to reduce sensitivity by occluding dentinal tubules and stabilizing collagen fibrils (Schupbach 
et al., 1997)6. However, the ideal timing of GLUMA application in different adhesive protocols remains 
uncertain, raising questions about its effect on postoperative sensitivity, adhesive bond strength, and long-
term restoration success. 
Few studies Sayed ME et al 20227 found that application of desensitizing agents on the prepared tooth 
surface for Class I cavity preparation for composite restoration reduces post- operative sensitivity where 
Gluma desensitizer found to reduce post-operative sensitivity when they were subjected to various stimuli 
such as cold drinks, intake of hot drinks, and intake of sugar for different periods of time which was scored 
based on the VAS (Visual Analog Scale).  However the research done by Sancakli HS et al 20148 found that 
no statistical differences were found with regard to post- operative sensitivity for occlusal composite 
restorations using different adhesive systems.  
This clinical trial aims to evaluate the effectiveness of GLUMA in controlling the immediate post treatment 
sensitivity following occlusal composite restorations. In addition, to compare the difference between the 

bonding systems (Etch-and-rinse & Self-etch) on reduction of post restoration sensitivity with or without 
Gluma desensitizer. 
Primary Research question: Does application of Gluma desensitizer effectively reduces post-operative 
sensitivity following occlusal composite restoration?  
For this clinical trial, a sample size of 504 restorations was calculated to be sufficient for detecting statistical 
difference using G* power software (α probability error – 0.05 and effect size – 0.2).    
The intervention of this clinical trial is application of GLUMA Desensitizer (Heraeus Kulzer GmbH, 
Wehreim, Germany) which is currently available in the market as a aqueous solution containing Purified 
water, 35% hydroxyethyl methacrylate (HEMA), 5%  glutaraldehyde, and pyrogenic silicic.  
5% of Glutaraldehyde component acts as a biological fixative, essentially coagulating proteins within the 
dentinal tubules and causing them to become blocked. This prevents the movement of fluid within the 
tubules, which is a primary cause of dentin hypersensitivity. 35% of HEMA is a hydrophilic monomer that 
also contributes to the occlusion of dentinal tubules. It enhances the penetration of the solution into the 
tubules and helps to further block the fluid flow. The mechanism of Gluma desensitizer is both the 
glutaraldehyde and HEMA work together to reduce the permeability of the dentin, thus minimizing the 
stimuli that trigger sensitivity. 
In this clinical trial the numbers of arms were randomly assigned to six groups. Blinding helps to ensure that 
the results of the study are more reliable and less influenced by the subjective opinions or expectations of 
the participants or researchers. Hence in this clinical trial, single-blinding was done. The participants of the 
study were informed about the trial but were unaware of which treatment group they were allocated to. The 
clinician and researcher were aware of the groups and treatments given. This blinding was also done to 
minimize bias that could arise from the patient's expectations or perceptions about the treatment. In this 
clinical trial all the patients were allocated using Block randomization, a technique which is used to ensure 
balance in treatment group sizes throughout the trial. It works by dividing participants into individual blocks 

and then randomly assigning treatments within each block, ensuring roughly equal numbers in each group 
within that block10. In this clinical trial, a block size of 6 (1, 2, 3, 4, 5, 6) was employed for equal enrolment. 
The prepared blocks were printed in sheets and patients who met the eligibility criteria were systematically 
assigned in a continuous fashion. After every 6th patient, the enrolment would continue on to the next block 
from 1.  
Arm Title 
Arm 1: Total Etch Control group (No desensitizer application) (n=84) 
Arm 2: Total Etch Gluma prior to acid etchant usage (n=84) 
Arm 3: Total Etch Gluma desensitizer application after acid etchant usage (n=84) 
 Arm 4: Self Etch Control group (No desensitizer application) (n=84) 
Arm 5: Self Etch Gluma desensitizer application prior to etching (n=84) 
Arm 6: Self Etch Gluma desensitizer application after self-etch adhesive usage (n=84) 
Arm information and description: 
Arm 1: Total Etch Control group (No desensitizer application) where 37% Phosphoric acid (Prime 
Dental Products Pvt Ltd.) was applied for 20 s on the prepared cavity followed by application of two 
coats of primer-bond solution (Te-Econom Bond, Ivoclar Vivadent) it was light-cured for 20s and then 
placement of Composite restoration (Charisma Smart, Kulzer Gmbh, Germany)  
Arm 2: Total Etch Gluma prior to acid etchant usage where Gluma (Kulzer GmbH, Germany) 
desensitizer application as per manufacturer’s instruction followed by application of 37% Phosphoric 
acid (Prime Dental Products Pvt Ltd.) was applied for 20 s on the prepared cavity followed by 
application of two coats of primer-bond solution (Te-Econom Bond", Ivoclar Vivadent) it was light-
cured for 20 s and then placement of Composite restoration (Charisma Smart, Kulzer Gmbh, Germany). 

Arm 3: Total Etch Gluma desensitizer application after acid etchant usage where 37% Phosphoric 
acid (Prime Dental Products Pvt Ltd.) was applied for 20 s on the prepared cavity followed by 
application of Gluma (Kulzer GmbH, Germany) desensitizer application as per manufacturer’s 
instruction later two coats of primer-bond solution (Te-Econom Bond", Ivoclar Vivadent) it was light-
cured for 20 s and then placement of Composite restoration (Charisma Smart, Kulzer Gmbh, Germany). 
Arm 4: Self Etch Control group (No desensitizer application) where no desensitizer was applied after 
preparing the cavity two coats of Universal adhesive (3M ESPE Single Bond Universal Adhesive, 
Germany) was applied. After curing the adhesives placement of Composite restoration (Charisma Smart, 
Kulzer Gmbh, Germany) is done. 
 
Arm 5: Self Etch Gluma desensitizer application prior to etching where Gluma (Kulzer GmbH, 
Germany) desensitizer application as per manufacturer’s instruction followed by two coats of Universal 
adhesive (3M ESPE Single Bond Universal Adhesive, Germany) was applied. After curing the 
adhesives placement of Composite restoration (Charisma Smart, Kulzer Gmbh, Germany) is done. 
Arm 6: Self Etch Gluma desensitizer application after self-etch adhesive usage where two coats of 
Universal adhesive (3M ESPE Single Bond Universal Adhesive, Germany) was applied followed by 
Gluma (Kulzer GmbH, Germany) desensitizer application as per manufacturer’s instruction and then 
placement of Composite restoration (Charisma Smart, Kulzer Gmbh, Germany). 
Arm information: 
 The agents used are Total Etch groups (Arm 1- Arm 3) are,  
Acid Etchant: 37% Phosphoric acid (Prime Dental Products Pvt Ltd.,)  
Bonding agent: Te-Econom Bond" is Ivoclar Vivadent,  

Composite (Charisma Smart, Kulzer Gmbh, Germany),  
Gluma Desensitizer (Kulzer GmbH, Germany).   
The agents used are Self Etch groups (Arm 4- Arm 6) are,  
Bonding agent: 3M ESPE Single Bond Universal Adhesive, Germany  
Composite (Charisma Smart, Kulzer Gmbh, Germany),  
Gluma Desensitizer (Kulzer GmbH, Germany).   
Intervention Type: Drug used in this clinical trial is Gluma Desensitizer (Kulzer GmbH, a German 
company). 
Description: Caries excavation was done using diamond burs (Mani Co., Tochigi, Japan) with water 
coolant. Extent of caries excavation was done until sound hard or firm discolored or non-discolored 
dentin was achieved. Extent of caries excavation was assessed by an Experienced Post Graduate 
Supervisor (EPGS) blinded to treatment allocation group. Those teeth with width of the cavity 
preparation were no more than 1/3rd of the inter-cuspal width were included. Radiographs (Durr PSP 
Sensor, Durr, Germany) are taken to assess the depth of the preparation and Remaining Dentin 
Thickness (RDT). Two RDT measurements from mesial and distal pulp horn to floor of the preparation 
were calculated. Mean RDT was derived from the two readings. Preparation extending beyond the 
middle third of the dentin or with pulp exposure is excluded from the study. Radiograph assessment was 
done by EPGS. Teeth were excluded from the study if  
they had pulp exposure or a prepared cavity that did not  
meet standardization requirements. 
 Intervention description for Arm 1 (Total Etch Control group (No desensitizer application) after 
cavity preparation, Total-etch adhesive was applied in the following way: 37% Phosphoric acid (Prime 

Dental Products Pvt Ltd., ) was applied for 20 s on the prepared cavity. The acid was then washed by air 
and water pressure through a triple syringe for 20s. The surface was lightly air-dried. Then two coats of 
primer-bond solution (Te-Econom Bond, Ivoclar Vivadent) were applied by scrubbing with a micro 
brush, for 20 s per coat. When the surface became shiny, it was light-cured for 20s (Woodpecker LED, 
Guilin, China). After curing the adhesives, the light-cured nano-composite (Charisma Smart, Kulzer 
Gmbh, Germany) was used for the restoration which was applied in increments (1–2 mm thick) by 
layering technique to reduce polymerization shrinkage.   
Occlusal interference is checked both in centric and lateral excursion and adjusted. Finishing and 
polishing of restoration is accomplished using Super snap (Shofu Inc., Japan).  
Intervention description for Arm 2: Total Etch Gluma prior to acid etchant usage in this group a 
small amount of Gluma Desensitizer (Kulzer GmbH, Germany) was applied to the prepared dentin 
surface for 30-60 seconds, and then gently dried with air until the surface is no longer shiny. Finally, 
rinse thoroughly with water and suction. Then Total-etch adhesive was applied 37% Phosphoric acid 
(Prime Dental Products Pvt Ltd.,) was applied for 20 s on the prepared cavity. The acid was then washed 
by air and water pressure through a triple syringe for 20s. The surface was lightly air-dried. Then two 
coats of primer-bond solution (Te-Econom Bond, Ivoclar Vivadent) were applied by scrubbing with a 
micro brush, for 20 s per coat. When the surface became shiny, it was light-cured for 20s (Woodpecker 
LED, Guilin, China). After curing the adhesives, the light-cured nano-composite (Charisma Smart, 
Kulzer Gmbh, Germany) was used for the restoration which was applied in increments (1–2 mm thick) 
by layering technique to reduce polymerization shrinkage.   
Intervention description for Arm 3: Total Etch Gluma desensitizer application after acid etchant 
usage after cavity preparation, 37% Phosphoric acid (Prime Dental Products Pvt Ltd.,) was applied for 
20 s on the prepared cavity. The acid was then washed by air and water pressure through a triple syringe 
for 20s. The surface was lightly air-dried. A small amount of Gluma Desensitizer (Kulzer GmbH, 
Germany) was applied to the prepared dentin surface for 30-60 seconds, and then gently dried with air 

until the surface is no longer shiny. Finally, rinse thoroughly with water and suction. Then two coats of 
primer-bond solution (Te-Econom Bond, Ivoclar Vivadent) were applied by scrubbing with a micro 
brush, for 20 s per coat. When the surface became shiny, it was light-cured for 20s (Woodpecker LED, 
Guilin, China). After curing the adhesives, the light-cured nano-composite (Charisma Smart, Kulzer 
Gmbh, Germany) was used for the restoration which was applied in increments (1–2 mm thick) by 
layering technique to reduce polymerization shrinkage.   
Intervention description for Arm 4: Self Etch Control group (No desensitizer application) where no 
desensitizer was applied after preparing the cavity two coats of Universal adhesive (3M ESPE Single 
Bond Universal Adhesive, Germany) were applied by scrubbing with a micro brush, for 20 s per coat. 
When the surface became shiny, it was light-cured for 20s (Woodpecker LED, Guilin, China). After 
curing the adhesives, placement of Composite (Charisma Smart, Kulzer Gmbh, Germany in increments 
(1–2 mm thick) by layering technique to reduce polymerization shrinkage.   
Intervention description for Arm 5: Self Etch Gluma desensitizer application prior to etching in this 
group a small amount of Gluma Desensitizer (Kulzer GmbH, Germany) was applied to the prepared 
dentin surface for 30-60 seconds, and then gently dried with air until the surface is no longer shiny. 
Finally, rinse thoroughly with water and suction. Followed by two coats of Universal adhesive (3M 
ESPE Single Bond Universal Adhesive, Germany) were applied by scrubbing with a micro brush, for 20 
s per coat. When the surface became shiny, it was light-cured for 20s (Woodpecker LED, Guilin, 
China). After curing the adhesives, placement of Composite (Charisma Smart, Kulzer Gmbh, Germany 
in increments (1–2 mm thick) by layering technique to reduce polymerization shrinkage.   
Intervention description for Arm 6: Self Etch Gluma desensitizer application after self-etch adhesive 
usage two coats of Universal adhesive (3M ESPE Single Bond Universal Adhesive, Germany) were 
applied by scrubbing with a micro brush, for 20 s per coat. When the surface became shiny, it was light-
cured for 20s (Woodpecker LED, Guilin, China). After curing the adhesives a small amount of Gluma 
Desensitizer (Kulzer GmbH, Germany) was applied to the prepared dentin surface for 30-60 seconds, 

and then gently dried with air until the surface is no longer shiny. Finally, rinse thoroughly with water 
and suction. Placement of Composite (Charisma Smart, Kulzer Gmbh, Germany in increments (1–2 mm 
thick) by layering technique to reduce polymerization shrinkage.   
Outcome measures  
The primary outcome of this clinical trial is to evaluate the effectiveness of GLUMA in controlling the 
immediate post treatment sensitivity following occlusal composite restorations. Hence, all the patients 
were assessed for post restoration sensitivity after 24 hours, 48 hours and at the end of one week.   
Post –operative sensitivity after 24 and 48 hours were assessed with VAS score (1- 10) through 
telephonic call by a resident student who are unaware of the treatment allocation group. The Visual 
Analogue Scale (VAS) is a common and effective tool for assessing pain and other subjective 
symptoms, including postoperative sensitivity. In this study a 1-10 scale were used and the patient is 
asked to choose a number ranging from 1 to 10 based on their sensitivity, with 1 being the least 
sensitivity and 10 being the most.  The advantages of VAS scale is its simplicity, ease of use and 
applicability.  
Post–operative sensitivity after one week all the patients were recalled and clinically assessed by Schiff 
cold air sensitivity scale by an Experienced Post Graduate Supervisor (EPGS) who is unaware of the 
allocated treatment groups and those patients with post-operative sensitivity of VAS > 3 were 
considered for the results (Berkowitz G et al 2013)11. A statistician also looked at the treatment results 
without knowing anything about them. 
Schiff cold air sensitivity scale is used to check for post-operative sensitivity which measures a patient's 
response to a cold air stimulus, helping to gauge the level of sensitivity in a tooth. The procedure 
involves directing a stream of air at the tooth and observing the patient's reaction, with scores ranging 
from no response to severe pain (intensity) requiring immediate discontinuation of the stimulus. 

The secondary outcome was to assess whether patient had post-operative sensitivity due to any trigger 
stimulus. This was assessed at the end of 24 hours, 48 hours and one week post –operatively. At 24 
hours and 48 hours through telephonic call a resident student who is unaware of the treatment allocation 
group questioned the patients those who had post-operative sensitivity whether the sensitivity is due to 
any stimuli (upon mastication/ intake of hot or cold) or spontaneous.  
At the end of one week the patients were recalled checked for post-operative sensitivity using both 
Schiff Air Scale and those patients with post-operative sensitivity of VAS > 3 were questioned whether 
sensitivity is due to any stimuli11 (upon mastication/ intake of hot or cold) or spontaneous.  
STATISTICAL ANALYSIS PLAN  
 
DEFINITION: 
The Kruskal-Wallis test is a non-parametric statistical test used to determine if there's a significant 
difference between the medians of three or more independent groups. It's an alternative to the one- 
way ANOVA when the data doesn't meet the assumptions of normality or equal variances. 
STATISTICAL ANALYSIS OVERVIEW: 
 
This present study contains six arms whose descriptions have been provided in the brief summary. 
The statistical analysis was performed using IBM SPSS version 23. The normality was assessed 
using Shapiro – wilks test and Q -Q plots. Since the groups do not follow the normal distribution 
Kruskal – Wallis test to test the statistical significance of post operative sensitivity among the 
groups. Mann – whitney U test was used to assess the post operative sensitivity among the control 
groups. 
GROUPS INVOLVED: 
 
CONTROL GROUPS: 
 
GROUP 1: Total Etch (TE) Control Group 

GROUP 2: Self Etch (SE) Control Group  
 
 
TEST GROUPS: 
GROUP 2: TE - GLUMA Application After Acid Etching 
GROUP 3: TE - GLUMA Application Prior to Acid Etching 
GROUP 5: SE - GLUMA Application Prior to Acid Etching 
GROUP 6: SE - GLUMA Application After Acid Etching

NULL HYPOTHESIS: 
 
The null hypothesis states that there is no statistically significant difference in post operative 
sensitivity on GLUMA application etching before or after total etching or self-etching followed by 
composite restoration of the carious teeth. 
SAMPLE SIZE CALCULATION: 
 
For this clinical trial, a sample size of 504 restorations was calculated to be sufficient for detecting 
statistical difference using G* power software (α probability error – 0.05 and effect size – 0.2). 
TYPE OF ANALYSIS: 
 
The type of trial is a Noninferiority trials. By definition a non – inferiority trial tests whether a new 
experimental treatment is not unacceptably less efficacious than an active control treatment already 
in use. With continuous improvements in health technologies, standard care, and clinical outcomes, 
the incremental benefits of newly developed treatments may be only marginal over existing 
treatments. (Hahn S. Understanding noninferiority trials. Korean journal of pediatrics. 2012 Nov 
23;55(11):403.) 
This test is a non - inferiority trial hence the six groups have GLUMA application before etching 
of a composite restoration which is not unacceptably less efficacious in reducing post operative 
sensitivity in composite restoration of a carious tooth. 
PROCEDURE: 
 
All statistical analyses were performed using non-parametric tests due to the non-normal 
distribution of the data, as confirmed by both the Kolmogorov–Smirnov and Shapiro–Wilk tests 

(p < 0.001). Descriptive statistics including mean and standard deviation (Mean ± SD) were 
calculated for each of the six desensitizer groups at different time points: Pre-operative, 24 hours, 
48 hours, and 1 week post-operative sensitivity, measured using the Visual Analog Scale (VAS). 
For intergroup comparisons across all six desensitizer protocols, the Kruskal–Wallis test was used 
independently for each time point. This non-parametric method was selected to assess statistically 
significant differences in median VAS ranks among the groups, given the violation of normality 
assumptions. A separate p-value was generated for each time point: 
 
Pre-operative VAS: p = 0.003 (significant) 
 
 
24-hour VAS: p = 0.126 (not significant) 
 
 
48-hour VAS: p = 0.050 (borderline) 
 
 
1-week VAS: p = 0.013 (significant) 
 
Pairwise comparisons between the Total-etch control and Self-etch control groups were 
performed using the Mann–Whitney U test. This analysis revealed a statistically significant 
difference in pre-operative VAS scores (p = 0.012), while post-operative scores showed no 
significant differences at 24 hours (p = 0.337). 
Mean pain scores (VAS) were also summarized for each group at all four-time intervals. The self- 
etch Gluma prior to etching group consistently showed the lowest VAS scores at all time 
points, suggesting reduced post-operative sensitivity in this group. 
Given the minimal differences in outcome scores among the other groups, and the slightly better 
performance of the self-etch GLUMA prior to etching group, the data suggest that most treatment 
protocols were non-inferior to the best-performing group. Therefore, the trial was interpreted as 

a non-inferiority study, evaluating whether the other etching and desensitizing protocols were 
not clinically worse than the most effective group. 
A significance level of p < 0.05 was considered statistically significant throughout the analysis. In 
the present study, the Kruskal-Wallis test was used to compare six desensitizer groups at different 
time intervals (Pre-operative, 24 hours, 48 hours, and 1 week post-operatively) based on Visual 
Analog Scale (VAS) scores. Since each time point represents a distinct clinical endpoint, a separate 
Kruskal-Wallis test was conducted for each, yielding individual p-values corresponding to each 
time point. As the Kruskal-Wallis test does not permit aggregation of multiple outcomes into a 
single p-value, a common p-value is not statistically appropriate. 
 
Ranks 
Desensitizer Group 
N 
Mean Rank 
P 
Valuea 
Pre Op VAS 
Total etch control 
86 
105.48 
0.003 
Total etch Gluma prior to
etching 
94 
141.70 
Total etch Gluma after
etching 
86 
116.12 
Self etch control 
82 
142.30 
Self etch Gluma prior to
etching 
80 
106.20 
Self etch Gluma after
etching 
76 
147.55 
Total 
504 
Post Op sensitivity 24hr
VAS 
Total etch control 
86 
125.47 
0.126 
Total etch Gluma prior to
etching 
94 
122.94 
Total etch Gluma after
etching 
86 
117.62 
Self etch control 
82 
136.49 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Kruskal – Wallis test 
p< 
0.05 
denotes 
statistically 
significant difference. All the values 
exhibit non – statistically significant 
difference. Statistical test applied * 
 
Ranks 
Desensitizer 
Group 
N 
Mean 
Rank 
*P Value 
Pre Op VAS 
Total etch control 86 
36.83 
0.012 
Self etch control 
82 
48.45 
Self etch Gluma prior to 
etching 
80 
125.30 
Self etch Gluma after 
etching 
76 
132.62 
Total 
504 
Post Op sensitivity 48hr 
VAS 
Total etch control 
86 
131.74 
0.050 
Total etch Gluma prior to 
etching 
94 
127.98 
Total etch Gluma after 
etching 
86 
123.48 
Self etch control 
132.76 
Self etch Gluma prior to 
etching 
80 
114.36 
Self etch Gluma after 
etching 
76 
128.18 
Total 
504 
Post Op sensitivity 1 
week VAS 
Total etch control 
86 
124.24 
Total etch Gluma prior to 
etching 
94 
130.96 
Total etch Gluma after 
etching 
86 
124.38 
Self etch control 
82 
129.76 
Self etch Gluma prior to 
etching 
80 
115.00 
0.013 
Self etch Gluma after 
etching 
76 
134.53 
Total 
504 

 
Total 
168 
Post Op sensitivity
24hr VAS 
Total etch control 86 
40.67 
0.337 
Self etch control 
82 
44.41 
Total 
168 
 
p< 0.05 denotes statistically significant difference. All the values exhibit non – statistically 
significant difference except the pre operative pain scores. Statistical test applied * Mann Whitney 
U test 
 
DESINSITIZING 
AGENT 
Pre Op VAS 
Post Op VAS (24 
hrs) 
Post Op VAS (48 
hrs) 
Post Op VAS (1 week) 
Mean±SD 
Mean±SD 
Mean±SD 
Mean±SD 
Total etch control 
0.86±1.67 
0.37±1.05 
0.37±1.05 
0.21±0.77 
Total etch Gluma 
prior to etching 
1.72±2.15 
0.49±1.33 
0.40±1.12 
0.23±0.81 
Total etch Gluma 
after etching 
1.16±2.07 
0.28±0.93 
0.28±0.93 
0.26±0.95 
Self etch control 
1.88±2.25 
0.66±1.32 
0.41±1.00 
0.12±0.33 
Self etch Gluma 
prior to etching 
0.63±1.05 
0.20±0.46 
0.03±0.16 
0.08±0.27 
Self etch Gluma 
after etching 
2.11±2.40 
0.61±1.31 
0.37±0.97 
0.21±0.53 
 
 
ESTIMATION PARAMETER: Mean Difference (Final Values) 
 
 
ESTIMATED VALUE: 
 
The mean post-operative sensitivity at 1 week was 0.18 units lower in the Self-etch Gluma 
prior to etching group compared to the Total etch Gluma after etching group, indicating 
that the former resulted in reduced sensitivity following restoration. 
 
CONFIDENCE INTERVAL: 95% 
 
 
NUMBER OF SIDES: 1 – sided 

LOWER LIMIT: 
Estimation Parameter: Mean Difference (Final Values) 
 
Estimated Value: +0.18 
 
Lower Limit (95% CI, one-sided): +0.003 
 
 
Parameter Dispersion Type: Standard Deviation 
 
Dispersion Value: 0.1077 
 
The dispersion represents the standard deviation of the difference in mean post-
operative sensitivity between the two groups. 
 
 
Age limits: Patient aged between 15 to 70 years of both the gender were included  
Healthy volunteers only/ with disease and why: The reason only healthy individuals are 
often enrolled because this helps to ensure that any observed effects are specifically 
related to dentin hypersensitivity and not influenced by other factors, such as an impaired 
immune response that could be present in individuals with certain systemic conditions.12 
Investigator’s Info:  
First name: GeethDeepika 
Middle name: Nil 
Last name: Kottai Gandhi  
Degree: MDS (Master of Dental Surgery)  
Phone Number: +91 9952 331820 
Email ID: geethdeepika@gmail.com 
College Info: CSI College of Dental Sciences and Research, Madurai (CSICDSR) 

 
 
 
 (Affiliated under TN Dr MGR Medical University, Chennai, India) 
Individual Patient sharing: Individual patient details are often not shared in this 
research due to concerns about privacy, confidentiality, and potential harm to participants, 
as well as practical and logistical challenges.13 
References:  
1. Porto I. Postoperative sensitivity on direct resin composite restorations: Clinical 
practice guidelines. Indian J. Restor. Dent. 2012; 1:1–12. 
2. Pashley DH, Pashley EL, Carvalho RM, Tay FR. The effects of dentin permeability 
on restorative dentistry. Dental Clinics. 2002 Apr 1; 46(2):211-45. 
3. Loguercio AD, Reis A, Schroeder M, Balducci I, Versluis A, Ballester RY. 
Polymerization shrinkage: effects of boundary conditions and filling technique of 
resin composite restorations. Journal of dentistry. 2004 Aug 1; 32(6):459-70. 
4. Mazzoni A, Tjäderhane L, Checchi V, Di Lenarda R, Salo T, Tay FR, Pashley DH, 
Breschi LO. Role of dentin MMPs in caries progression and bond stability. Journal of 
dental research. 2015 Feb; 94(2):241-51. 
5. Swift EJ, Ritter AV, Heymann HO, Sturdevant JR, Wilder AD 36-month clinical 
evaluation of two adhesives and microhybrid resin composites in Class I restorations. 
Am J Dent. 2008; 21:148-152. 
6. Schupbach P, Lutz F, Finger WJ. Closing of dentinal tubules by Gluma desensitizer. 
European journal of oral sciences. 1997 Oct; 105(5P1):414-21. 
7. Sayed ME, Dewan H, Kharaf R, Athlawi M, Alfaifi M, Mugri MH, Bosly RA, 
Fageehi NY, Hadi M, Zurbtan BJ, Shaabi FI, Alsurayyie FH, Bukhary DM, Alshali 
RZ, Chohan H. Efficacy of Three Commercially Available Desensitizers in Reducing 
Post-Operative Sensitivity Following Composite Restorations: A Randomized 

Controlled Clinical Trial. Polymers (Basel). 2022 Mar 30; 14(7):1417. doi: 
10.3390/polym14071417. 
8. Sancakli HS, Yildiz E, Bayrak I, Ozel S. Effect of different adhesive strategies on the 
post-operative sensitivity of class I composite restorations. Eur J Dent. 2014 Jan; 
8(1):15-22. doi: 10.4103/1305-7456.126234. 
9. Joshi S, Gowda AS, Joshi C. Comparative evaluation of NovaMin desensitizer and 
Gluma desensitizer on dentinal tubule occlusion: a scanning electron microscopic 
study. 
J 
Periodontal 
Implant 
Sci. 
2013 
Dec; 
43(6):269-75. 
doi: 
10.5051/jpis.2013.43.6.269. 
10. Elheeny, A.A.H., Hussien, O.SE., Abdelmotelb, M.A. et al. A 12-month randomized 
controlled trial to assess the efficacy of revitalization of retreated mature incisors with 
periapical 
radiolucency 
in 
adolescents. 
Sci 
Rep 
14, 
16366 
(2024). 
https://doi.org/10.1038/s41598-024-66305-5. 
11. Berkowitz G, Spielman H, Matthews A, Vena D, Craig R, Curro F, Thompson V. 
Postoperative hypersensitivity and its relationship to preparation variables in Class I 
resin-based composite restorations: findings from the practitioners engaged in applied 
research and learning (PEARL) Network. Part 1. Compend Contin Educ Dent. 2013 
Mar; 34(3):e44-52. PMID: 23631638; PMCID: PMC4264581. 
12. Dionysopoulos D, Gerasimidou O, Beltes C. Dentin Hypersensitivity: Etiology, 
Diagnosis and Contemporary Therapeutic Approaches—A Review in Literature. 
Applied Sciences. 2023; 13(21):11632. https://doi.org/10.3390/app132111632.  
13. Hollis KF. To Share or Not to Share: Ethical Acquisition and Use of Medical Data. 
AMIA Jt Summits Transl Sci Proc. 2016 Jul 20;2016:420-7. PMID: 27570683; 
PMCID: PMC5001759.