Dental Root SensitivityNCT05588518
Propolis as a Treatment for Cervical Dentin Hypersensitivity
A study testing desensitizing agents -10% Propolis in people with Dental Root Sensitivity, run by King Khalid University at 1 site in Saudi Arabia.
Trial summary
Fluoridated desensitizers the frequently used for the treatment of dentin hypersensitivity (DH) with Iontophoresis. This study aimed to evaluate and compare the immediate and long-term effects of 10% Propolis with 2% sodium fluoride and 1.23% acidulated phosphate fluoride when applied along with Iontophoresis for the… Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Root Sensitivity
- What is being tested?
- desensitizing agents -10% Propolis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Apr 2019to 1 Aug 2020
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy (based on the medical and drug history.), needing oral prophylaxis with moderate calculus (subjects who have moderately poor oral hygiene and needs teeth cleaning), at least two non-adjacent hypersensitive teeth with Schiff scale score as >1 with air blast stimulus and availability of a minimum of 10 evaluable natural teeth excluding third molars.
Who cannot join
- Undergoing orthodontic therapy, undertreatment for DH/using desensitizing dentifrice, pregnant women, any history of periodontal treatment before three months, any history of asthma, allergic to honey bee products and pollen, teeth with dental caries, attrition, abrasion, erosion, and lack of vitality.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Dentistry King Khalid University
Abhā, 'Asir Region, 65412
About this study
Official title: Randomized Clinical Trial and Comparison of Propolis With Sodium Fluoride and Acidulated Phosphate Fluoride Using Iontophoresis as a Treatment for Cervical Dentin Hypersensitivity
Fluoridated desensitizers the frequently used for the treatment of dentin hypersensitivity (DH) with Iontophoresis. This study aimed to evaluate and compare the immediate and long-term effects of 10% Propolis with 2% sodium fluoride and 1.23% acidulated phosphate fluoride when applied along with Iontophoresis for the treatment of cervical dentin hypersensitivity (DH). Single-center, parallel, and double-blinded randomized clinical trials were conducted on systemically healthy patients, complaining about DH, with at least two sites. 10% propolis, 2% Sodium Fluoride and 1.23% Acidulated Phosphate Fluoride were used as desensitizers along with the Iontophoresis. After applying specific stimuli any decrease in DH was measured at baseline before and after application, on the 14th day after use, and at 28th-day post-intervention time intervals.
Read the detailed description
Preparation of the materials 10 milligrams of Sodium Fluoride powder was mixed with 500 ml of distilled water to attain 500 ml of 2% concentrated Sodium Fluoride solution. Commercially available Acidulated Phosphate Fluoride was used at 1.23% concentration. Preparation of propolis: Commercially available raw Indian propolis in wax form was obtained from Hi-Tech Natural Product India Limited, New Delhi, India. 10% propolis was prepared after mixing with of 70% ethanol and distilled water based on the method described previously. Propolis and ethanol mixture was allowed to stay in a dark place for two weeks. The mixture was stirred everyday intermittently for two weeks. Later the mixture was strained twice using filter paper (Whatman International Ltd. England) to remove impurities. Propolis in general is fairly stable without losing its antibacterial properties for over 12 months when stored without direct sunlight and at cool temperatures. Alcohol-based extracts will have extended shelf life and hence ethanol-extracted propolis prepared was stored in the dark amber-colored bottle without any preservatives.
Study Design The trial was designed after multiple discussions among the authors and strictly followed the guidelines of CONSORT (Consolidated standards of reporting trials). It was a single centered, parallel, and double-blinded randomized clinical trial, approved by an institutional ethical review board and thesis protocol was registered in concerned medical university. Centralized computer-generated randomization was done without any restrictions. Randomization codes were kept sealed and managed by the central pharmacy to follow the allocation concealment. The DH measurements were performed by two blinded examiners (NMB and NRR), and averages were noted at each time interval. Each time, while checking, a new sheet of paper was given to the examiners to record the measurements, and to hide the old measures, to prevent bias. Interventions were carried out by another blinded author (TS). Cronbach's Alpha for inter-examiner reliability was found to be 0.92 and intra-examiner reliability 0.85 and 0.82 for examiner 1 and 2 respectively.
Study Participants Consecutive patients who visited the Department of Periodontology; from April 2019 to August 2020, with the DH as a chief complaint, with an age range of 25-60 years were invited to join in the study. Participating in the study was purely voluntary. Written informed consent was taken from each patient. The willing patients were assessed for following the necessary eligibility criteria.
Patients included were: Systemically healthy (based on the medical and drug history.), needing oral prophylaxis with moderate calculus (subjects who have moderately poor oral hygiene and needs teeth cleaning), at least two non-adjacent hypersensitive teeth with Schiff scale score as >1 with air blast stimulus and availability of a minimum of 10 evaluable natural teeth excluding third molars. However, patients excluded were: Undergoing orthodontic therapy, undertreatment for DH/using desensitizing dentifrice, pregnant women, any history of periodontal treatment before three months, any history of asthma, allergic to honey bee products and pollen, teeth with dental caries, attrition, abrasion, erosion, and lack of vitality.
Patients were allocated to three test groups after randomization. Oral prophylaxis was done in all three groups; baseline DH levels were then evaluated.
Application of desensitizing agents Vaseline was generally applied all over the gingiva and mucosa with a cotton pellet to foil the soft tissues from any undesired effect. Desensitizers used in test groups were 10% Propolis, 2% Sodium Fluoride, and 1.23% Acidulated Phosphate Fluoride for the first, second, and third group, respectively. A respective desensitizer, the pea-sized quantity was smeared over the test tooth. Subsequently, Iontophoresis was applied immediately in all three groups. The desensitizing agent was administered at two intervals, immediately after oral prophylaxis and at the 14th-day visit.
Application of Iontophoresis Iontophoresis equipment (Medical S.R.L., Italy) was used in this study. The procedure includes application of electric current on the test tooth for penetration of ions through dentinal tubules. Based on the patient arch size, the corresponding tray size is selected. A sponge used over the tray for placing the desensitizer. A particular desensitizer is applied in the sponge based on the respective subject's study group. The tray along with a sponge is then positioned in the patient mouth. The patient was instructed to hold the positive electrode of the iontophoresis unit with his/her palm. The negative electrode was connected to the metal plate in the tray. The unit is now switched on, and a current of 2 milliamperes is applied for one minute, based on manufacturer specifications. After one minute, the unit is switched off, and the same procedure is employed on the opposing arch. The patient is advised not to drink/eat or rinse his mouth for another half an hour.
Assessing clinical parameters Tactile, air blast and cold water stimuli were applied in the given order. Reduction of the DH (primary outcome) was traced at the baseline, immediately after ultrasonic scaling, and shortly after desensitizer application, postoperative 14 days before and after application of desensitizer, and postoperative 28 days without any application. A careful check for any adverse reactions with desensitizers was done at all intervals. The tactile test was done with the help of pressure sensitive probe. Immediate apical to the cementoenamel junction, the probe was moved from distal to mesial direction, graded as 1-10 on the visual analogue scale (VAS) based on the patient's discomfort. A four-graded Schiff's scale measured air stimulus. Zero was taken as no response, one as a response is noticed but the subject does not request for discontinuation of the stimulus, two as a response is noticed and the subject requests for discontinuation of the stimulus, three as pain is seen and the subject requests for discontinuation of the stimulus. A cold-water test was done with cold water application drop by drop with a disposable syringe, measured with VAS.
All the study subjects across study groups were provided with Colgate Regular Toothpaste and a soft-bristle toothbrush. The study subjects were demonstrated modified Stillman's toothbrushing technique on an oversized tooth model and instructed to brush once in the morning and once before sleep at night for 2-3 minutes from the first day till the end of the follow-up period.
- Conditions
- Dental Root Sensitivity
- Being tested
- desensitizing agents -10% Propolis
- Keywords
- Dental calculus, Dentine sensitivity, Gingival recession
- Medical subject headings
- Dental Calculus, Dentin Sensitivity, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desensitizing agents -10% PropolisCombination product
10% propolis was prepared after mixing with 70% ethanol and distilled water based on the method described previously. Propolis and ethanol mixture was allowed to stay in dark place for two weeks. The mixture was stirred everyday intermittently for two weeks. Later the mixture was strained twice using filter paper to remove impurities.
Propolis in general are fairly stable without losing its antibacterial properties for over 12 months when stored without direct sunlight and at cool temperatures. Alcohol based extracts will have extended shelf life and hence ethanol-extracted propolis prepared was stored in dark amber colored bottle without any preservatives.
| Study group | Role | What they receive |
|---|---|---|
| test group-1- 10% propolis | Experimental | 10% propolis desensitizer, a pea-sized quantity was smeared over the test tooth. Subsequently, Iontophoresis was applied immediately. The desensitizing agent was administered at two intervals, immediately after oral prophylaxis and at the 14th-day visit. Receives: Combination Product: desensitizing agents -10% Propolis |
| test group -2- 2% sodium fluoride | Active comparator | 2% sodium fluoride desensitizer, a pea-sized quantity was smeared over the test tooth. Subsequently, Iontophoresis was applied immediately. The desensitizing agent was administered at two intervals, immediately after oral prophylaxis and at the 14th-day visit. Receives: Combination Product: desensitizing agents -10% Propolis |
| test group-3- 1.23% acidulated phosphate fluoride | Active comparator | 1.23% acidulated phosphate fluoride desensitizer, a pea-sized quantity was smeared over the test tooth. Subsequently, Iontophoresis was applied immediately. The desensitizing agent was administered at two intervals, immediately after oral prophylaxis and at the 14th-day visit. Receives: Combination Product: desensitizing agents -10% Propolis |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduced dentin hypersensitivity
significant reduction in dentin hypersensitivity
Measured: baseline (0 day) to 28th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Apr 2019
- Primary completion1 Feb 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental Root 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Khalid University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raghavendra Reddy Nagate, King Khalid University
- Investigators
- Raghavendra R Nagate, MDS, Principal investigator, King Khalid University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588518
- Sponsor's protocol ID
- IRB/KKUCOD/ETH/2018-19/112
- Status last verified
- Oct 2022
- First submitted
- 15 Oct 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Purra AR, Mushtaq M, Acharya SR, Saraswati V. A comparative evaluation of propolis and 5.0% potassium nitrate as a dentine desensitizer: A clinical study. J Indian Soc Periodontol. 2014 Jul;18(4):466-71. doi: 10.4103/0972-124X.138695.
PubMed 25210261Torwane NA, Hongal S, Goel P, Chandrashekar BR, Jain M, Saxena E. A clinical efficacy of 30% ethenolic extract of Indian propolis and Recaldent in management of dentinal hypersensitivity: A comparative randomized clinical trial. Eur J Dent. 2013 Oct;7(4):461-468. doi: 10.4103/1305-7456.120675.
PubMed 24932122Madhavan S, Nayak M, Shenoy A, Shetty R, Prasad K. Dentinal hypersensitivity: A comparative clinical evaluation of CPP-ACP F, sodium fluoride, propolis, and placebo. J Conserv Dent. 2012 Oct;15(4):315-8. doi: 10.4103/0972-0707.101882.
PubMed 23112475
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial and Comparison of Propolis With Sodium Fluoride and Acidulated Phosphate Fluoride Using Iontophoresis as a Treatment for Cervical Dentin Hypersensitivity
- ClinicalTrials.gov ID
- NCT05588518
- Acronym / sponsor ID
- IRB/KKUCOD/ETH/2018-19/112
- Conditions
- Dental Root Sensitivity
- Keywords
- Dental calculus, Dentine sensitivity, Gingival recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- King Khalid UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 20 Oct 2022 (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.
Fluoridated desensitizers the frequently used for the treatment of dentin hypersensitivity (DH) with Iontophoresis. This study aimed to evaluate and compare the immediate and long-term effects of 10% Propolis with 2% sodium fluoride and 1.23% acidulated phosphate fluoride when applied along with Iontophoresis for the treatment of cervical dentin hypersensitivity (DH). Single-center, parallel, and double-blinded randomized clinical trials were conducted on systemically healthy patients, complaining about DH, with at least two sites. 10% propolis, 2% Sodium Fluoride and 1.23% Acidulated Phosphate Fluoride were used as desensitizers along with the Iontophoresis. After applying specific stimuli any decrease in DH was measured at baseline before and after application, on the 14th day after use, and at 28th-day post-intervention time intervals.
Detailed description
Preparation of the materials 10 milligrams of Sodium Fluoride powder was mixed with 500 ml of distilled water to attain 500 ml of 2% concentrated Sodium Fluoride solution. Commercially available Acidulated Phosphate Fluoride was used at 1.23% concentration. Preparation of propolis: Commercially available raw Indian propolis in wax form was obtained from Hi-Tech Natural Product India Limited, New Delhi, India. 10% propolis was prepared after mixing with of 70% ethanol and distilled water based on the method described previously. Propolis and ethanol mixture was allowed to stay in a dark place for two weeks. The mixture was stirred everyday intermittently for two weeks. Later the mixture was strained twice using filter paper (Whatman International Ltd. England) to remove impurities. Propolis in general is fairly stable without losing its antibacterial properties for over 12 months when stored without direct sunlight and at cool temperatures. Alcohol-based extracts will have extended shelf life and hence ethanol-extracted propolis prepared was stored in the dark amber-colored bottle without any preservatives.
Study Design The trial was designed after multiple discussions among the authors and strictly followed the guidelines of CONSORT (Consolidated standards of reporting trials). It was a single centered, parallel, and double-blinded randomized clinical trial, approved by an institutional ethical review board and thesis protocol was registered in concerned medical university. Centralized computer-generated randomization was done without any restrictions. Randomization codes were kept sealed and managed by the central pharmacy to follow the allocation concealment. The DH measurements were performed by two blinded examiners (NMB and NRR), and averages were noted at each time interval. Each time, while checking, a new sheet of paper was given to the examiners to record the measurements, and to hide the old measures, to prevent bias. Interventions were carried out by another blinded author (TS). Cronbach's Alpha for inter-examiner reliability was found to be 0.92 and intra-examiner reliability 0.85 and 0.82 for examiner 1 and 2 respectively.
Study Participants Consecutive patients who visited the Department of Periodontology; from April 2019 to August 2020, with the DH as a chief complaint, with an age range of 25-60 years were invited to join in the study. Participating in the study was purely voluntary. Written informed consent was taken from each patient. The willing patients were assessed for following the necessary eligibility criteria.
Patients included were: Systemically healthy (based on the medical and drug history.), needing oral prophylaxis with moderate calculus (subjects who have moderately poor oral hygiene and needs teeth cleaning), at least two non-adjacent hypersensitive teeth with Schiff scale score as >1 with air blast stimulus and availability of a minimum of 10 evaluable natural teeth excluding third molars. However, patients excluded were: Undergoing orthodontic therapy, undertreatment for DH/using desensitizing dentifrice, pregnant women, any history of periodontal treatment before three months, any history of asthma, allergic to honey bee products and pollen, teeth with dental caries, attrition, abrasion, erosion, and lack of vitality.
Patients were allocated to three test groups after randomization. Oral prophylaxis was done in all three groups; baseline DH levels were then evaluated.
Application of desensitizing agents Vaseline was generally applied all over the gingiva and mucosa with a cotton pellet to foil the soft tissues from any undesired effect. Desensitizers used in test groups were 10% Propolis, 2% Sodium Fluoride, and 1.23% Acidulated Phosphate Fluoride for the first, second, and third group, respectively. A respective desensitizer, the pea-sized quantity was smeared over the test tooth. Subsequently, Iontophoresis was applied immediately in all three groups. The desensitizing agent was administered at two intervals, immediately after oral prophylaxis and at the 14th-day visit.
Application of Iontophoresis Iontophoresis equipment (Medical S.R.L., Italy) was used in this study. The procedure includes application of electric current on the test tooth for penetration of ions through dentinal tubules. Based on the patient arch size, the corresponding tray size is selected. A sponge used over the tray for placing the desensitizer. A particular desensitizer is applied in the sponge based on the respective subject's study group. The tray along with a sponge is then positioned in the patient mouth. The patient was instructed to hold the positive electrode of the iontophoresis unit with his/her palm. The negative electrode was connected to the metal plate in the tray. The unit is now switched on, and a current of 2 milliamperes is applied for one minute, based on manufacturer specifications. After one minute, the unit is switched off, and the same procedure is employed on the opposing arch. The patient is advised not to drink/eat or rinse his mouth for another half an hour.
Assessing clinical parameters Tactile, air blast and cold water stimuli were applied in the given order. Reduction of the DH (primary outcome) was traced at the baseline, immediately after ultrasonic scaling, and shortly after desensitizer application, postoperative 14 days before and after application of desensitizer, and postoperative 28 days without any application. A careful check for any adverse reactions with desensitizers was done at all intervals. The tactile test was done with the help of pressure sensitive probe. Immediate apical to the cementoenamel junction, the probe was moved from distal to mesial direction, graded as 1-10 on the visual analogue scale (VAS) based on the patient's discomfort. A four-graded Schiff's scale measured air stimulus. Zero was taken as no response, one as a response is noticed but the subject does not request for discontinuation of the stimulus, two as a response is noticed and the subject requests for discontinuation of the stimulus, three as pain is seen and the subject requests for discontinuation of the stimulus. A cold-water test was done with cold water application drop by drop with a disposable syringe, measured with VAS.
All the study subjects across study groups were provided with Colgate Regular Toothpaste and a soft-bristle toothbrush. The study subjects were demonstrated modified Stillman's toothbrushing technique on an oversized tooth model and instructed to brush once in the morning and once before sleep at night for 2-3 minutes from the first day till the end of the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| test group-1- 10% propolis | Experimental | Combination Product: desensitizing agents -10% Propolis10% propolis desensitizer, a pea-sized quantity was smeared over the test tooth. Subsequently, Iontophoresis was applied immediately. The desensitizing agent was administered at two intervals, immediately after oral prophylaxis and at the 14th-day visit. |
| test group -2- 2% sodium fluoride | Active comparator | Combination Product: desensitizing agents -10% Propolis2% sodium fluoride desensitizer, a pea-sized quantity was smeared over the test tooth. Subsequently, Iontophoresis was applied immediately. The desensitizing agent was administered at two intervals, immediately after oral prophylaxis and at the 14th-day visit. |
| test group-3- 1.23% acidulated phosphate fluoride | Active comparator | Combination Product: desensitizing agents -10% Propolis1.23% acidulated phosphate fluoride desensitizer, a pea-sized quantity was smeared over the test tooth. Subsequently, Iontophoresis was applied immediately. The desensitizing agent was administered at two intervals, immediately after oral prophylaxis and at the 14th-day visit. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Systemically healthy (based on the medical and drug history.), needing oral prophylaxis with moderate calculus (subjects who have moderately poor oral hygiene and needs teeth cleaning), at least two non-adjacent hypersensitive teeth with Schiff scale score as >1 with air blast stimulus and availability of a minimum of 10 evaluable natural teeth excluding third molars.
Key exclusion criteria (1 listed)
- Undergoing orthodontic therapy, undertreatment for DH/using desensitizing dentifrice, pregnant women, any history of periodontal treatment before three months, any history of asthma, allergic to honey bee products and pollen, teeth with dental caries, attrition, abrasion, erosion, and lack of vitality.
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 |
|---|---|---|
| desensitizing agents -10% Propolis10% propolis was prepared after mixing with 70% ethanol and distilled water based on the method described previously. Propolis and ethanol mixture was allowed to stay in dark place for two weeks. The mixture was stirred everyday intermittently for two weeks. Later the mixture was strained twice using filter paper to remove impurities. Propolis in general are fairly stable without losing its antibacterial properties for over 12 months when stored without direct sunlight and at cool temperatures. Alcohol based extracts will have extended shelf life and hence ethanol-extracted propolis prepared was stored in dark amber colored bottle without any preservatives. | Combination product | test group -2- 2% sodium fluoride, test group-1- 10% propolis, test group-3- 1.23% acidulated phosphate fluoride |
Primary outcome
reduced dentin hypersensitivity
Time frame: baseline (0 day) to 28th day
significant reduction in dentin hypersensitivity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Background: PubMed 25210261Purra AR, Mushtaq M, Acharya SR, Saraswati V. A comparative evaluation of propolis and 5.0% potassium nitrate as a dentine desensitizer: A clinical study. J Indian Soc Periodontol. 2014 Jul;18(4):466-71. doi: 10.4103/0972-124X.138695.
- Background: PubMed 24932122Torwane NA, Hongal S, Goel P, Chandrashekar BR, Jain M, Saxena E. A clinical efficacy of 30% ethenolic extract of Indian propolis and Recaldent in management of dentinal hypersensitivity: A comparative randomized clinical trial. Eur J Dent. 2013 Oct;7(4):461-468. doi: 10.4103/1305-7456.120675.
- Background: PubMed 23112475Madhavan S, Nayak M, Shenoy A, Shetty R, Prasad K. Dentinal hypersensitivity: A comparative clinical evaluation of CPP-ACP F, sodium fluoride, propolis, and placebo. J Conserv Dent. 2012 Oct;15(4):315-8. doi: 10.4103/0972-0707.101882.
- Individual participant dataSharing planned: No
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.
Raghavendra R Nagate, MDS principal investigator
King Khalid 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 desensitizing agents -10% Propolis in people with Dental Root Sensitivity, run by King Khalid University at 1 site in Saudi Arabia.
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 1 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 2022. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduced dentin hypersensitivity (time frame: baseline (0 day) to 28th day). 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 NCT05588518, which also lists 3 linked publications.
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 2022.