Dentine HypersensitivityEarly Phase 1NCT04754763

A Comparative Study On The Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity

A Early Phase 1 study testing Dentin-Bonding Agents and Propolis in people with Dentine Hypersensitivity, run by Dow University of Health Sciences at 1 site in Pakistan.

Completed

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

Official record

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Trial summary

Background: Dentine hypersensitivity (DH) causes considerable pain and discomfort to an individual due to number of stimuli on exposed dentine. Different kinds of treatment strategies are used in the resolution of dentine hypersensitivity including the use of propolis and dentine bonding agent. Read more about this study

Who is it for?: Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Dentine Hypersensitivity
What is being tested?: Dentin-Bonding Agents and Propolis
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 sitePakistan
Study dates: 1 Jun 2018to 30 Jul 2019
Phase: Early Phase 1
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Outpatients reporting to Periodontology department of Dow International Dental College (DIDC) with dentine hypersensitivity
Patients having age of 20- 45 years
Systemically healthy patients
Patients having at least 2 vital teeth with hypersensitivity
Patients having sensitivity on facial surfaces to air stimulus
Patients with Score I of Silness and Loe Plaque Index 77
Patients who used Fluoride dentifrices for hypersensitivity but could not get relief from it.

Who cannot join

Patients with carious, cracked or restored teeth, abutment teeth used of removable or fixed prosthesis and tooth with any other dental pathology
Patients who used analgesics, mood alteration drugs during last six months
Smoker, pregnant and nursing mothers
Patients who used tooth whitening or bleaching agents in the last six months
Patients who were undergoing orthodontic therapy and history of periodontal surgery during last six months

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Dow International Dental Campus (Defence Campus)
Karachi, Sindh

Other trials in Pakistan

About this study

Official title: A Comparative Study On The Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity: A Randomized Clinical Trial

Background:

Dentine hypersensitivity (DH) causes considerable pain and discomfort to an individual due to number of stimuli on exposed dentine. Different kinds of treatment strategies are used in the resolution of dentine hypersensitivity including the use of propolis and dentine bonding agent. No study had compared the efficacy of propolis and dentine bonding agent.

Objective:

The objective of the study was to find out whether there is a difference in the efficacy of Propolis and seventh generation dentine bonding agent in reducing the dentine hypersensitivity. Comparison within the groups and pairwise comparisons were also recorded in reducing dentine hypersensitivity.

Methods:

In this six month In- Vivo single blinded randomized clinical study, a total number of 52 patients with complain of dentine hypersensitivity were selected in two groups after taking informed consent. Group A and B received 30% ethanolic extract of propolis and dentine bonding agents respectively by a trained operator. Recordings of dentine hypersensitivity were obtained at Day 0, before and after the application of experimental agents, and also on Day 7, 15 and 30 by the principal investigator. Response was measured by Visual Analog Scale and Schiff Cold Air Sensitivity Scale. Statistical Package for the Social Sciences (SPSS) version 20 was used to analyze the data with level of significance set at p < 0.05. Friedman test was applied to see the comparison within groups and Wilcoxon Signed Rank test was used for Pairwise comparison. Mann Whitney U-Test was applied for comparison between groups.

Conditions: Dentine Hypersensitivity
Being tested: Dentin-Bonding Agents, Propolis
Medical subject headings: Dentin Sensitivity

What participants receive

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

Dentin-Bonding AgentsDrug
3M ESPE Scotchbond™ Universal Adhesive systems is a seventh generation single-bottled one-step self-etch adhesive system.
PropolisDrug
Propolis was obtained from Margalla hills, Islamabad by NARC (National Agriculture Research Council, Islamabad). Plant source origin is Acacia modesta and Apis mellifera bees collect it. The 30% ethanolic extract of propolis from raw propolis was obtained in Pakistan Council of Scientific \& Industrial Research (PCSIR) by dissolving the propolis in 95% ethanol and straining out the precipitate

Study groups in NCT04754763
Study group	Role	What they receive
Propolis	Experimental	Propolis was applied by disposable micro brush on particular sensitive teeth and left undisturbed for 60 seconds to let it dry. Followup was done at 7th, 15th and 30th day Receives: Drug: Propolis
Seventh generation Dentine Bonding Agent (Scotchbond™ Universal Adhesive, 3M ESPE)	Active comparator	Application of Seventh generation Dentine Bonding Agent (Scotchbond™ Universal Adhesive, 3M ESPE) on sensitive surfaces was applied single coated for 20 seconds, gently applied air for 5 seconds and cured for 10 seconds (as per manufacturer's instructions). Followup was done at 7th, 15th and 30th day Receives: Drug: Dentin-Bonding Agents

What is being measured

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

Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained at Day 0, before the application of experimental agents.
Visual Analog Scale which will be scored as 0 (No Pain), 1-3 (Mild Pain), 4-6 (Moderate Pain) and 7-10 (Severe Pain).
Measured: Before application of experimental agents (Day 0)
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained at Day 0, before the application of experimental agents.
Schiff Cold Air Sensitivity Scale is mainly used to evaluate subject response to a stimulus like air or evaporative. This scale is scored as follows:
1. Subject does not respond to air stimulus.
2. Subject responds to air stimulus but does not request discontinuation of stimulus.
3. Subject responds to air stimulus and requests discontinuation or moves from stimulus.
4. Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus
Measured: Before application of experimental agents (Day 0)
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Scale. Recordings were obtained at Day 0, after the application of experimental agents.
Measured: 1 minute after application of experimental agents (Day 0)
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained at Day 0, after the application of experimental agents.
Measured: 1 minute after application of experimental agents (Day 0)
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained on Day 7.
Measured: Day 7
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained on Day 7.
Measured: Day 7
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained on Day 15.
Measured: Day 15
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained on Day 15.
Measured: Day 15
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained on Day 30.
Measured: Day 30
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained on Day 30.
Measured: Day 30

Timeline

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

1 Jun 201830 Jul 2019

First posted15 Feb 2021
Study start1 Jun 2018
Primary completion31 May 2019
Study completion30 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Dentine HypersensitivityStudies 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: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04754763
Sponsor's protocol ID: AAkber
Status last verified: Feb 2021
First submitted: 14 Jan 2021
Last updated: 15 Feb 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

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

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

Questions to ask the study team

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

See locations

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All Dentine Hypersensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparative Study On The Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04754763
Acronym / sponsor ID: AAkber
Conditions: Dentine Hypersensitivity
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Dow University of Health SciencesUniversity, hospital or other
Study start: 1 Jun 2018 (actual)
Primary completion: 31 May 2019 (actual)
Study completion: 30 Jul 2019 (actual)
First posted: 15 Feb 2021 (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.

Background:

Objective:

Methods:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Propolis	Experimental	Drug: PropolisPropolis was applied by disposable micro brush on particular sensitive teeth and left undisturbed for 60 seconds to let it dry. Followup was done at 7th, 15th and 30th day
Seventh generation Dentine Bonding Agent (Scotchbond™ Universal Adhesive, 3M ESPE)	Active comparator	Drug: Dentin-Bonding AgentsApplication of Seventh generation Dentine Bonding Agent (Scotchbond™ Universal Adhesive, 3M ESPE) on sensitive surfaces was applied single coated for 20 seconds, gently applied air for 5 seconds and cured for 10 seconds (as per manufacturer's instructions). Followup was done at 7th, 15th and 30th day

Who may qualify

Ages: 20 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Outpatients reporting to Periodontology department of Dow International Dental College (DIDC) with dentine hypersensitivity
Patients having age of 20- 45 years
Systemically healthy patients
Patients having at least 2 vital teeth with hypersensitivity
Patients having sensitivity on facial surfaces to air stimulus

Key exclusion criteria (5 listed)

Patients with carious, cracked or restored teeth, abutment teeth used of removable or fixed prosthesis and tooth with any other dental pathology
Patients who used analgesics, mood alteration drugs during last six months
Smoker, pregnant and nursing mothers
Patients who used tooth whitening or bleaching agents in the last six months
Patients who were undergoing orthodontic therapy and history of periodontal surgery during last six months

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
Dentin-Bonding Agents3M ESPE Scotchbond™ Universal Adhesive systems is a seventh generation single-bottled one-step self-etch adhesive system.	Drug	Seventh generation Dentine Bonding Agent (Scotchbond™ Universal Adhesive, 3M ESPE)
PropolisPropolis was obtained from Margalla hills, Islamabad by NARC (National Agriculture Research Council, Islamabad). Plant source origin is Acacia modesta and Apis mellifera bees collect it. The 30% ethanolic extract of propolis from raw propolis was obtained in Pakistan Council of Scientific \& Industrial Research (PCSIR) by dissolving the propolis in 95% ethanol and straining out the precipitate	Drug	Propolis

Primary outcome

Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Time frame: Before application of experimental agents (Day 0)
Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained at Day 0, before the application of experimental agents. Visual Analog Scale which will be scored as 0 (No Pain), 1-3 (Mild Pain), 4-6 (Moderate Pain) and 7-10 (Severe Pain).
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Time frame: Before application of experimental agents (Day 0)
Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained at Day 0, before the application of experimental agents. Schiff Cold Air Sensitivity Scale is mainly used to evaluate subject response to a stimulus like air or evaporative. This scale is scored as follows: 1. Subject does not respond to air stimulus. 2. Subject responds to air stimulus but does not request discontinuation of stimulus. 3. Subject responds to air stimulus and requests discontinuation or moves from stimulus. 4. Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Time frame: 1 minute after application of experimental agents (Day 0)
Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Scale. Recordings were obtained at Day 0, after the application of experimental agents.
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Time frame: 1 minute after application of experimental agents (Day 0)
Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained at Day 0, after the application of experimental agents.
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Time frame: Day 7
Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained on Day 7.
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Time frame: Day 7
Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained on Day 7.
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Time frame: Day 15
Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained on Day 15.
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Time frame: Day 15
Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained on Day 15.
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Time frame: Day 30
Treatment of dentine hypersensitivity assessed with the help of Visual Analog Scale (VAS). Recordings were obtained on Day 30.
Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Time frame: Day 30
Treatment of dentine hypersensitivity assessed with the help of Schiff Cold Air Sensitivity Scale. Recordings were obtained on Day 30.

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 15 Feb 2021.
Individual participant dataSharing planned: No

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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.

Ather Akber, M.Sc principal investigator

Dow University of Health Sciences

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

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Dentin-Bonding Agents and Propolis in people with Dentine Hypersensitivity, run by Dow University of Health Sciences 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 7 inclusion and 5 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 15 Feb 2021. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity (time frame: Before application of experimental agents (Day 0)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04754763.

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 15 Feb 2021.