Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417580
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-04-11
Brief Title:
Effect of Pregabalin Gel in Controlling Cervical Dentin Hypersensitivity
Sponsor:
Jesuína Lamartine Nogueira Araújo
Organization:
Universidade Federal do Para
Study Overview
Official Title:
Effect of Experimental Pregabalin Gel in Controlling Cervical Dentin Hypersensitivity a Randomized Double-blind Controlled Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized double-blind placebo-controlled clinical study aims to evaluate the effect of a gel formulation based on 10 of pregabalin in the treatment of HD and on the participants quality of life The sample calculation will be based on previous work After selecting participants the participants will be randomly assigned to the following groups placebo control group CG potassium nitrate gel group GNK and pregabalin gel group GPG A questionnaire QEDH-15 to assess the impact of desensitizing treatment on oral health-related quality of life OHRQoL will be applied at baseline T0 and in the last sensitivity record T6 Pain will be assessed using a visual analogue scale after evaporative stimulation with an air jet and tactile stimulation with an exploratory probe Three desensitizing treatment sessions will be carried out with an interval of 72 hours between them Sensitivity recording will be performed at T0 baseline T1 after the first session T2 after the second session T3 after the third session T4 7 days after the last session T5 one month after the last session and T6 3 months after the last session Data will be collected and subjected to statistical analysis for parametric data ANOVA followed by Student-Newman-Keuls or non-parametric data Friedmans ANOVA followed by Tukey To analyze the impact on quality of life the Friedman test will be used
Detailed Description:
To obtain the experimental pregabalin gel a carbopol 940 gel base was used To prepare the base gel for the formulation each component was weighed on an analytical balance and after 24 hours the components were taken to a mechanical shaker rotating at 1000 rpm for 10 minutes 50 triethanolamine was added to adjust the pH to 6 and complete gel formation The concentrations of the components of the initial base formula were adjusted to obtain a homogeneous transparent gel with good consistency A PG solution 10 mgml was prepared by diluting the drug which is presented as a white crystalline powder Vardhman Chemtech Ltd Punjab India with purified water The solution was stirred for 10 min in a water bath Taitec and centrifuged at 4C for 10 min The supernatant obtained was collected and then incorporated into the 1 carbopol-based gel
This formulation has already been evaluated in a previous study regarding quality standards physicalchemical characterization cytotoxicity and subjected to stability analyzes preliminary and accelerated Its characteristics indicate that it is a favorable formulation for clinical application
This randomized clinical study will follow the guidelines for clinical trials recommended by CONSORT Consolidated Standards Of Reporting Trials and will be submitted to the Human Research Ethics Committee of the Institute of Health Sciences at the Federal University of Pará CEP-ICSUFPA All selected participants who agree to participate in the research will be informed about the benefits risks methods and goals of the study before consenting to their participation through the Informed Consent Form declaring that the participants agree with all the steps to be taken The participants can withdraw from the research at any time following the principles of the Declaration of Helsinki
This randomized clinical trial will be parallel double-blind placebo-controlled and all clinical interventions will be conducted in the clinics of the Faculty of Dentistry of the Federal University of Pará FOUFPa The research will consist of three groups a placebo control group CG with gel without any active ingredient a group with potassium nitrate gel Ultradent South Jordan UT USA GNK and an experimental group with gel 10 Pregabalin GPG Applications will be carried out in 3 sessions with an interval of 72 hours between each one Sensitivity recording will be performed at T0 baseline T1 after the first session T2 after the second session T3 after the third session T4 7 days after the last session and T5 one month after the last session and T6 3 months after the last session
A questionnaire QEDH-15 will be applied to evaluate the impact of desensitizing treatment on improving the participants oral health-related quality of life HRQoL The questionnaire will be applied at baseline T0 and the last sensitivity record T6 Higher QEHD-15 scores indicate a negative impact on the oral health-related quality of life OHRQoL of research participants
The sample size was determined using the GPower 31 program Heinrich-Heine-Universität Düsseldorf Germany based on a comparison of intergroup means According to previous studies the minimum expected difference is 226 and a standard deviation of 2 between groups An alpha of 5 power of 80 and a 20 increase in possible loss of participants were considered The final sample size determined was 63 teeth in total 21 sensitive teeth per group
To evaluate the painful sensation of hypersensitivity a Visual Analogue Scale VAS will be used The initial mark 0 represents no pain and the opposite mark 10 represents extreme pain
The participant will be asked to signal the number compatible with the painful sensation after applying the evaporative stimulus by applying a jet of air from a triple syringe for two seconds at room temperature perpendicular to the buccal surface of the tooth at a distance of 1cm and also by tactile stimulation where a cross-shaped exploring probe will slide into the cervical region of the hypersensitive teeth vertically in the cervical-incisal direction and horizontally in the mesiodistal direction These stimuli will be performed after relative individual isolation with isolation tape Isotape Septodont Louisville USA and cotton rolls Dental Cremer SC Brazil
Random distribution between the groups will be carried out in a block through a numerical draw that allows each participant to be allocated into one of the three groups GC GNK and GPG using Biostat 53 software Instituto Mamirauá PA Brazil The confidentiality of the allocation will be maintained throughout the sample formation process through a numerical draw with numbered and coded papers All participants and the clinical operator will not know the groups codes
This double-blind study guarantees the confidentiality of the interventions since both the research participant and the main researcher will not be able to differentiate the procedure applied The placebo gel the experimental desensitizing gel and the potassium nitrate gel will be inserted into a dappen jar and delivered immediately before the clinical interventions by a research collaborator The gels have a similar texture color and odor to prevent identification The evaluator will also not be aware of the group the participant belonged to as the clinical operator will not participate in the randomization process The research will have a single operator to carry out the clinical part
The data will be analyzed for normality of distribution using the Shapiro-Wilk test If it presents a normal distribution the ANOVA parametric analysis will be used to verify the existence of differences between the group means and the Student-Newman-Keuls post-hoc test will be used to verify the differences between the times In case of abnormal distribution the Friedman repeated measures test and the Tukey post hoc test will be used To analyze differences in quality of life-related to oral health at T0 and T6 the Friedman test will be used Data analysis will be performed using the freely available statistical software Jamovi Version 23 The significance level α will be set at p005
This formulation has already been evaluated in a previous study regarding quality standards physicalchemical characterization cytotoxicity and subjected to stability analyzes preliminary and accelerated Its characteristics indicate that it is a favorable formulation for clinical application
This randomized clinical study will follow the guidelines for clinical trials recommended by CONSORT Consolidated Standards Of Reporting Trials and will be submitted to the Human Research Ethics Committee of the Institute of Health Sciences at the Federal University of Pará CEP-ICSUFPA All selected participants who agree to participate in the research will be informed about the benefits risks methods and goals of the study before consenting to their participation through the Informed Consent Form declaring that the participants agree with all the steps to be taken The participants can withdraw from the research at any time following the principles of the Declaration of Helsinki
This randomized clinical trial will be parallel double-blind placebo-controlled and all clinical interventions will be conducted in the clinics of the Faculty of Dentistry of the Federal University of Pará FOUFPa The research will consist of three groups a placebo control group CG with gel without any active ingredient a group with potassium nitrate gel Ultradent South Jordan UT USA GNK and an experimental group with gel 10 Pregabalin GPG Applications will be carried out in 3 sessions with an interval of 72 hours between each one Sensitivity recording will be performed at T0 baseline T1 after the first session T2 after the second session T3 after the third session T4 7 days after the last session and T5 one month after the last session and T6 3 months after the last session
A questionnaire QEDH-15 will be applied to evaluate the impact of desensitizing treatment on improving the participants oral health-related quality of life HRQoL The questionnaire will be applied at baseline T0 and the last sensitivity record T6 Higher QEHD-15 scores indicate a negative impact on the oral health-related quality of life OHRQoL of research participants
The sample size was determined using the GPower 31 program Heinrich-Heine-Universität Düsseldorf Germany based on a comparison of intergroup means According to previous studies the minimum expected difference is 226 and a standard deviation of 2 between groups An alpha of 5 power of 80 and a 20 increase in possible loss of participants were considered The final sample size determined was 63 teeth in total 21 sensitive teeth per group
To evaluate the painful sensation of hypersensitivity a Visual Analogue Scale VAS will be used The initial mark 0 represents no pain and the opposite mark 10 represents extreme pain
The participant will be asked to signal the number compatible with the painful sensation after applying the evaporative stimulus by applying a jet of air from a triple syringe for two seconds at room temperature perpendicular to the buccal surface of the tooth at a distance of 1cm and also by tactile stimulation where a cross-shaped exploring probe will slide into the cervical region of the hypersensitive teeth vertically in the cervical-incisal direction and horizontally in the mesiodistal direction These stimuli will be performed after relative individual isolation with isolation tape Isotape Septodont Louisville USA and cotton rolls Dental Cremer SC Brazil
Random distribution between the groups will be carried out in a block through a numerical draw that allows each participant to be allocated into one of the three groups GC GNK and GPG using Biostat 53 software Instituto Mamirauá PA Brazil The confidentiality of the allocation will be maintained throughout the sample formation process through a numerical draw with numbered and coded papers All participants and the clinical operator will not know the groups codes
This double-blind study guarantees the confidentiality of the interventions since both the research participant and the main researcher will not be able to differentiate the procedure applied The placebo gel the experimental desensitizing gel and the potassium nitrate gel will be inserted into a dappen jar and delivered immediately before the clinical interventions by a research collaborator The gels have a similar texture color and odor to prevent identification The evaluator will also not be aware of the group the participant belonged to as the clinical operator will not participate in the randomization process The research will have a single operator to carry out the clinical part
The data will be analyzed for normality of distribution using the Shapiro-Wilk test If it presents a normal distribution the ANOVA parametric analysis will be used to verify the existence of differences between the group means and the Student-Newman-Keuls post-hoc test will be used to verify the differences between the times In case of abnormal distribution the Friedman repeated measures test and the Tukey post hoc test will be used To analyze differences in quality of life-related to oral health at T0 and T6 the Friedman test will be used Data analysis will be performed using the freely available statistical software Jamovi Version 23 The significance level α will be set at p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None