Dentin SensitivityNCT05895526
Comparison of the Effectiveness of Self Etch Adhesive and Fluoride Varnish in Reducing Hypersensitivity in Patients With Gingival Recession
A study testing Self etch dentin adhesive, Fluoride varnish in people with Dentin Sensitivity, run by Prime Foundation at 1 site in Pakistan.
Trial summary
Comparison of the clinical effectiveness of self etch adhesive and fluoride varnish in reducing dentin hypersensitivity in patients with gingival recession. A Randomized Clinical Trial ABSTRACT Objective: To compare the clinical effectiveness of self etch adhesive and fluoride varnish in reducing dentin… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Self etch dentin adhesive, Fluoride varnish
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Jun 2023to 12 Aug 2023
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient with dentin hypersensitivity due to gingival recession.
- Patients having Miller's Class 1 gingival recession.
- Patient aged between 20-45yrs with gingival recession without other periodontal issues.
- Patient without root filled teeth.
- Patients who are willing to participate in the study.
Who cannot join
- Teeth with extensive gingival recession.
- Teeth with cervical restoration.
- Pregnant and lactating mother.
- Crowned teeth.
Trial locations and contacts
1 site in 1 country.
Sobia Owais, BDS contact
Pakistan1 site
Peshawar Dental College
Peshawar, Khyber Pakhtunkhwa
Iftikhar Akbar, BDS, CHPE, 00923479368676, driftikhar156@hotmail.com
Sobia Owais, BDS, sohakhan9541@gmail.com
About this study
Official title: Comparison of the Clinical Effectiveness of Self Etch Adhesive and Fluoride Varnish in Reducing Dentin Hypersensitivity in Patients With Gingival Recession: Randomized Clinical Trial
Comparison of the clinical effectiveness of self etch adhesive and fluoride varnish in reducing dentin hypersensitivity in patients with gingival recession. A Randomized Clinical Trial
ABSTRACT Objective: To compare the clinical effectiveness of self etch adhesive and fluoride varnish in reducing dentin hypersensitivity in patients with gingival recession
Read more
Study Design: Randomized Clinical Trial Place of Study: Department of Operative Dentistry and Endodontics, Peshawar Dental College, Warsak Road.
Methodology: 142 diagnosed cases of Dentin hypersensitivity from outpatient department of nephrology, Prime Hospital Peshawar will be referred to operative department, Peshawar dental college for Comparison of the clinical effectiveness of self etch adhesive and fluoride varnish in reducing dentin hypersensitivity in patients with gingival recession.
Results:
Conclusion:
Read the detailed description
Dentin hypersensitivity is a common disorder and is one of the most irritating clinical condition1. It is one of the everyday complaints from patient visiting dental operatory2. Dentin hypersensitivity has been defined as "Short, sharp pain arising from exposed dentin in response to stimuli typically thermal, evaporative , tactile , osmotic or chemical that cannot be related to any other dental defect or pathology"3'4.Prevalance of dentin hypersensitivity in general population is 4% to 57% 5. Adults are normally affected by dentin hypersensitivity mainly in their late 30s however mainly people aged between 29 to 49 years can also suffer from this6.
One of the most well known theory for dentin hypersensitivity is Brannstorm and Astrom's Hydrodynamic theory2'6. According to this theory environmental ,thermal, chemical changes cause the movement of fluid within tubules, which stimulate terminals of pulpal nerve fibers located in tubules, this will lead to acute transient pain6'7.
Dentin is composed of dentinal tubules and dentin is protected by highly mineralized structures i.e enamel covers the dentin in crown portion while root dentin is protected by cementum8.Certain type of physical, chemical, pathological and biological challenges or developing defects can lead to exposure of dentin. Periodontal tissue loss or gingival recession is one of the most predisposing factor because it will lead to exposure of cervical and root dentin2.
A lot of research has been done on treatment of dentin hypersensitivity but still no consensus has been reached on which product is "gold standard" for treatment of dentin hypersensitivity9.Lukomsky suggested that fluoride can be used as topical desensitizing agent for reduction of DH. It has been in use since 1941.Fluoride causes formation of calcium fluoride crystals and varying degree of fluorapatite which will block the transmission of noxious stimuli to pulp. For treatment of dentin hypersensitivity varnishes containing sodium fluoride as an active component are in use for many years9.Some researchers recommended the use of self etch adhesive for reduction of dentin permeability10.Self etch adhesive form acid resistant hybrid layer due to which they show high level of clinical effectiveness. Yu et al showed that one bottle self etch adhesive plays an effective role in alleviating symptoms of dentin hypersensitivity11.
The aim of current clinical study is to compare clinical effectiveness of self etch and fluoride varnish in reducing dentin hypersensitivity in patients with gingival recession.
Approval to carry out the study was sought from institutional Ethical Review Committee at Peshawar dental college before start of study. Study design was randomized control trial. By using Open epi, the total sample size will be 142 by using a duration of hypersensitivity(pain score) in group A (1.79±1.47) while in group B (2.41±1.22) from a previous study of Ammarah Afreen by keeping 80% Power of the test and 95% confidence interval9.
A prospective randomized clinical study will be planned at Operative Dentistry and Endodontics Department from 12 June, 2023 to 12 ,August 2023.This single center, double blind prospective RCT study will be conducted in Peshawar Dental College and Hospital. The inclusion criteria will be dentin hypersensitivity due to Miller's Class 1 gingival recession, aged between 20-45yrs, without root filled teeth and the patients who are willing to participate in the study. Whereas pregnant and lactating mother, crowned teeth with extensive gingival recession and with cervical restoration will be excluded.
All the selected patients have Miller's Class1 gingival recession in which marginal tissue recession does not extend to the mucogingival junction. Patients were informed regarding purpose, procedure, risk and benefits of the study. Verbal and written informed consent was obtained from all patient regarding his/her participation in study, and they were assured of maintaining confidentiality of the data collected from them. A structured customized performa was specifically designed to record the findings of study. The subjects were randomized by using random number table to minimize bias.
Patients were divided into two groups. The Group 1(Control Group) received the treatment that was based on the fluoride varnish company's instruction whereas Group 2 patients were under treatment regimens based on self etch dentin adhesive company's instruction.Teeth that are hypersensitive were identified using straight probe running cervically evaluating each tooth response. Tooth response to cold air was assessed using standard air syringe of dental unit for one to two seconds. In Group 1, After baseline assessment hypersensitivity were cleaned with cotton pellet soaked in distilled water, fluoride varnish was applied according to company's instruction whereas in group 2 self-etch adhesive, Optibond TM was applied for 20 seconds, dried with high pressure air flow for 5 seconds and light cured for 10 seconds according to manufacturer instruction. All subjects were instructed not to brush their teeth, eat, drink or rinse their mouth for at least two hours after each treatment.
A clinical evaluation of each tooth was assessed by another investigator who was not involved with the treatment procedure. Air stimulation response measurement was done via VAS as the baseline evaluation (T0) before intervention and data was collected, on the day of intervention after application of agents(T1), after one week (T2) and one month after treatment (T3) using tactile and air blast stimuli. The same examiner calculated the total VAS score of each study group at each follow up time from the mean of VAS scores of all treated teeth of every subject in the same group.
Baseline characteristics will also be compared. SPSS 22(SPSS Inc, Chicago, IL) will be used for all statistical analyses. The independent sample t-test will be used to analyze samples. The chi-square test will be used to assess the differences between categoric variables. The comparisons will be considered statistically significant at P < .05.
- Conditions
- Dentin Sensitivity
- Being tested
- Self etch dentin adhesive, Fluoride varnish
- Keywords
- Dentin permeability, Dentin hypersensitivity, Gingival recession
- Medical subject headings
- Dentin Sensitivity, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self etch dentin adhesive, Fluoride varnishProcedure or surgery
After an informed consent, in one group 5% sodium fluoride varnish will be applied in affected area, while the other group will receive self etch dentin adhesive.
| Study group | Role | What they receive |
|---|---|---|
| 5% Sodium Fluoride Varnish | Experimental | 71 patients will be in 5% Sodium Fluoride Varnish Receives: Procedure: Self etch dentin adhesive, Fluoride varnish |
| Self Etch Dentin Adhesive | Experimental | 71 patients will be in Self Etch Dentin Adhesive Receives: Procedure: Self etch dentin adhesive, Fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the clinical effectiveness of self etch adhesive and fluoride varnish in reducing dentin hypersensitivity in patients with gingival recession. A Randomized Clinical Trial
Patients will be divided into two groups. The Group 1 will receive the treatment that is based on the fluoride varnish company's instruction whereas Group 2 patients will under treatment regimens based on self etch dentin adhesive company's instructions.A clinical evaluation of each tooth will be done by another investigator who will not be involved with the treatment procedure. Air stimulation response measurement will be done via Visual analogue scale with score 0( No pain) ,1 2 3 ( Mild pain) , 4 5 6 (Moderate Pain) , 7 8 9 10 (Severe pain).The baseline evaluation (T0) before intervention , on the day of intervention after application of agents(T1), after one week (T2) and one month after treatment (T3) using tactile and air blast stimuli.The same examiner will calculate the total Visual analogue scale score of each study group at each follow up time from the mean of Visual analogue scale scores of all treated teeth of every subject in the same group..
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start12 Jun 2023 (estimated)
- Primary completion12 Aug 2023 (estimated)
- Study completion12 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin SensitivityStudies 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
- 1. Group A (Application of 5% sodium fluoride varnish) 2. Group B (Self etch dentin adhesive)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prime Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iftikhar Akbar, Prime Foundation
- Investigators
- Rizwan Qureshi, BDS, FCPS, Study chair, Peshawar Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895526
- Sponsor's protocol ID
- PDC
- Status last verified
- Jun 2023
- First submitted
- 12 Apr 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Effectiveness of Self Etch Adhesive and Fluoride Varnish in Reducing Dentin Hypersensitivity in Patients With Gingival Recession: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05895526
- Acronym / sponsor ID
- PDC
- Conditions
- Dentin Sensitivity
- Keywords
- Dentin permeability, Dentin hypersensitivity, Gingival recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Prime FoundationUniversity, hospital or other
- Study start
- 12 Jun 2023 (estimated)
- Primary completion
- 12 Aug 2023 (estimated)
- Study completion
- 12 Aug 2023 (estimated)
- First posted
- 8 Jun 2023 (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.
Comparison of the clinical effectiveness of self etch adhesive and fluoride varnish in reducing dentin hypersensitivity in patients with gingival recession. A Randomized Clinical Trial
ABSTRACT Objective: To compare the clinical effectiveness of self etch adhesive and fluoride varnish in reducing dentin hypersensitivity in patients with gingival recession
Study Design: Randomized Clinical Trial Place of Study: Department of Operative Dentistry and Endodontics, Peshawar Dental College, Warsak Road.
Methodology: 142 diagnosed cases of Dentin hypersensitivity from outpatient department of nephrology, Prime Hospital Peshawar will be referred to operative department, Peshawar dental college for Comparison of the clinical effectiveness of self etch adhesive and fluoride varnish in reducing dentin hypersensitivity in patients with gingival recession.
Results:
Conclusion:
Detailed description
Dentin hypersensitivity is a common disorder and is one of the most irritating clinical condition1. It is one of the everyday complaints from patient visiting dental operatory2. Dentin hypersensitivity has been defined as "Short, sharp pain arising from exposed dentin in response to stimuli typically thermal, evaporative , tactile , osmotic or chemical that cannot be related to any other dental defect or pathology"3'4.Prevalance of dentin hypersensitivity in general population is 4% to 57% 5. Adults are normally affected by dentin hypersensitivity mainly in their late 30s however mainly people aged between 29 to 49 years can also suffer from this6.
One of the most well known theory for dentin hypersensitivity is Brannstorm and Astrom's Hydrodynamic theory2'6. According to this theory environmental ,thermal, chemical changes cause the movement of fluid within tubules, which stimulate terminals of pulpal nerve fibers located in tubules, this will lead to acute transient pain6'7.
Dentin is composed of dentinal tubules and dentin is protected by highly mineralized structures i.e enamel covers the dentin in crown portion while root dentin is protected by cementum8.Certain type of physical, chemical, pathological and biological challenges or developing defects can lead to exposure of dentin. Periodontal tissue loss or gingival recession is one of the most predisposing factor because it will lead to exposure of cervical and root dentin2.
A lot of research has been done on treatment of dentin hypersensitivity but still no consensus has been reached on which product is "gold standard" for treatment of dentin hypersensitivity9.Lukomsky suggested that fluoride can be used as topical desensitizing agent for reduction of DH. It has been in use since 1941.Fluoride causes formation of calcium fluoride crystals and varying degree of fluorapatite which will block the transmission of noxious stimuli to pulp. For treatment of dentin hypersensitivity varnishes containing sodium fluoride as an active component are in use for many years9.Some researchers recommended the use of self etch adhesive for reduction of dentin permeability10.Self etch adhesive form acid resistant hybrid layer due to which they show high level of clinical effectiveness. Yu et al showed that one bottle self etch adhesive plays an effective role in alleviating symptoms of dentin hypersensitivity11.
The aim of current clinical study is to compare clinical effectiveness of self etch and fluoride varnish in reducing dentin hypersensitivity in patients with gingival recession.
Approval to carry out the study was sought from institutional Ethical Review Committee at Peshawar dental college before start of study. Study design was randomized control trial. By using Open epi, the total sample size will be 142 by using a duration of hypersensitivity(pain score) in group A (1.79±1.47) while in group B (2.41±1.22) from a previous study of Ammarah Afreen by keeping 80% Power of the test and 95% confidence interval9.
A prospective randomized clinical study will be planned at Operative Dentistry and Endodontics Department from 12 June, 2023 to 12 ,August 2023.This single center, double blind prospective RCT study will be conducted in Peshawar Dental College and Hospital. The inclusion criteria will be dentin hypersensitivity due to Miller's Class 1 gingival recession, aged between 20-45yrs, without root filled teeth and the patients who are willing to participate in the study. Whereas pregnant and lactating mother, crowned teeth with extensive gingival recession and with cervical restoration will be excluded.
All the selected patients have Miller's Class1 gingival recession in which marginal tissue recession does not extend to the mucogingival junction. Patients were informed regarding purpose, procedure, risk and benefits of the study. Verbal and written informed consent was obtained from all patient regarding his/her participation in study, and they were assured of maintaining confidentiality of the data collected from them. A structured customized performa was specifically designed to record the findings of study. The subjects were randomized by using random number table to minimize bias.
Patients were divided into two groups. The Group 1(Control Group) received the treatment that was based on the fluoride varnish company's instruction whereas Group 2 patients were under treatment regimens based on self etch dentin adhesive company's instruction.Teeth that are hypersensitive were identified using straight probe running cervically evaluating each tooth response. Tooth response to cold air was assessed using standard air syringe of dental unit for one to two seconds. In Group 1, After baseline assessment hypersensitivity were cleaned with cotton pellet soaked in distilled water, fluoride varnish was applied according to company's instruction whereas in group 2 self-etch adhesive, Optibond TM was applied for 20 seconds, dried with high pressure air flow for 5 seconds and light cured for 10 seconds according to manufacturer instruction. All subjects were instructed not to brush their teeth, eat, drink or rinse their mouth for at least two hours after each treatment.
A clinical evaluation of each tooth was assessed by another investigator who was not involved with the treatment procedure. Air stimulation response measurement was done via VAS as the baseline evaluation (T0) before intervention and data was collected, on the day of intervention after application of agents(T1), after one week (T2) and one month after treatment (T3) using tactile and air blast stimuli. The same examiner calculated the total VAS score of each study group at each follow up time from the mean of VAS scores of all treated teeth of every subject in the same group.
Baseline characteristics will also be compared. SPSS 22(SPSS Inc, Chicago, IL) will be used for all statistical analyses. The independent sample t-test will be used to analyze samples. The chi-square test will be used to assess the differences between categoric variables. The comparisons will be considered statistically significant at P < .05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 1. Group A (Application of 5% sodium fluoride varnish) 2. Group B (Self etch dentin adhesive)
| Arm | Type | Receives |
|---|---|---|
| 5% Sodium Fluoride Varnish | Experimental | Procedure: Self etch dentin adhesive, Fluoride varnish71 patients will be in 5% Sodium Fluoride Varnish |
| Self Etch Dentin Adhesive | Experimental | Procedure: Self etch dentin adhesive, Fluoride varnish71 patients will be in Self Etch Dentin Adhesive |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient with dentin hypersensitivity due to gingival recession.
- Patients having Miller's Class 1 gingival recession.
- Patient aged between 20-45yrs with gingival recession without other periodontal issues.
- Patient without root filled teeth.
- Patients who are willing to participate in the study.
Key exclusion criteria (4 listed)
- Teeth with extensive gingival recession.
- Teeth with cervical restoration.
- Pregnant and lactating mother.
- Crowned teeth.
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 |
|---|---|---|
| Self etch dentin adhesive, Fluoride varnishAfter an informed consent, in one group 5% sodium fluoride varnish will be applied in affected area, while the other group will receive self etch dentin adhesive. | Procedure or surgery | 5% Sodium Fluoride Varnish, Self Etch Dentin Adhesive |
Primary outcome
Comparison of the clinical effectiveness of self etch adhesive and fluoride varnish in reducing dentin hypersensitivity in patients with gingival recession. A Randomized Clinical Trial
Time frame: Two months
Patients will be divided into two groups. The Group 1 will receive the treatment that is based on the fluoride varnish company's instruction whereas Group 2 patients will under treatment regimens based on self etch dentin adhesive company's instructions.A clinical evaluation of each tooth will be done by another investigator who will not be involved with the treatment procedure. Air stimulation response measurement will be done via Visual analogue scale with score 0( No pain) ,1 2 3 ( Mild pain) , 4 5 6 (Moderate Pain) , 7 8 9 10 (Severe pain).The baseline evaluation (T0) before intervention , on the day of intervention after application of agents(T1), after one week (T2) and one month after treatment (T3) using tactile and air blast stimuli.The same examiner will calculate the total Visual analogue scale score of each study group at each follow up time from the mean of Visual analogue scale scores of all treated teeth of every subject in the same group..
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
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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.
Sobia Owais, BDS contact
Rizwan Qureshi, BDS, FCPS study chair
Peshawar Dental College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self etch dentin adhesive, Fluoride varnish in people with Dentin Sensitivity, run by Prime Foundation at 1 site in Pakistan.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Jun 2023. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iftikhar Akbar, FCPS, CHPE (00923479368676, driftikhar156@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the clinical effectiveness of self etch adhesive and fluoride varnish in reducing dentin hypersensitivity in patients with gingival recession. A Randomized Clinical Trial (time frame: Two 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 8 Jun 2023.