Post Operative PainNCT05569590
Efficacy of Desensitizing Agent,Propolis After an In-office Vital Tooth Bleaching.
A study testing Propolis, hydrogen peroxide 35% and fluoride varnish in people with Post Operative Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
This study was conducted to evaluate the efficacy of desensitizing agent Propolis, after an in -office vital tooth bleaching and to compare its desensitizing effect to traditionally used desensitizing agent fluoride varnish. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Propolis, hydrogen peroxide 35% and fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 14 May 2021to 22 Jun 2022
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Presence of all anterior teeth with mild to moderate discoloration
- Patient's age must be 18 to 30 years
- Absence of pre-operative pain or sensitivity
- Patients having no history of smoking
- Patients with no cervical lesions and exposed roots
- Good oral hygiene using simplified oral hygiene index
Show all 13Show fewer
- NO or minimum dental hypersensitivity to heat and cold before bleaching.
- Exclusion Criteria:• Patients with any kind of restoration, calculus or heavy stain on study site
- Candidates with severe discoloration
- Gross pathology with in oral cavity
- The Presence of heavy stains or calculus on study sites.
- Patients using any analgesics
- Patients having the use of desensitizing agent in any form.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effiacacy of Desensitizing Agent,After an In-office Vital Tooth Bleaching. A Randomized Double Blind Clinical Trial Trial.
This study was conducted to evaluate the efficacy of desensitizing agent Propolis, after an in -office vital tooth bleaching and to compare its desensitizing effect to traditionally used desensitizing agent fluoride varnish.
Methods: Considering the inclusion and exclusion criteria 90 patients will be selected at the OPD of Dow University of Health Sciences Ojha campus with mild to moderate discoloration and randomly divided in to three groups group A control group (fluoride varnish) group B Propolis and group C Propolis mixed with bleaching agent. After performing the bleaching procedure respective desensitizing agent was applied to each group for 10 minutes. Visual analogue scale and Schiff's scale were used to assess the sensitivity after completion of treatment. Subjective non stimulated assessment of sensitivity was done by using the visual analogue scale from day 1 till day 7 on given Performa and Objective stimulated assessment of sensitivity was done at the dental office on day 1 right after the procedure and at day 7 on follow-up after one week.
Kruskal-Wallis test was applied to check median pain score and sensitivity difference between and among the groups. Mann-Whitney U test was applied to check further pairwise comparison between the groups.
Read the detailed description
Dental aesthetic is one of the great importance to the patients, various causes of tooth discoloration which usually encountered are dental fluorosis, aging, staining, smoking, medication use, etc. Different treatment options are available to treat discoloration depends on the individual case. Dental bleaching is one of the most conservative, noninvasive, low cost effective treatment modality to treat discoloration. In vital tooth bleaching dentists use 35 to 38 % hydrogen peroxide which have the deleterious effects on tooth structures. The main problem which is usually experienced by the patients with the vital tooth bleaching is dentine hypersensitivity. Methods: Considering the inclusion and exclusion criteria 90 patients will be selected at the OPD of Dow University of Health Sciences Ojha campus with mild to moderate discoloration and randomly divided in to three groups group A control group (fluoride varnish) group B Propolis and group C Propolis mixed with bleaching agent. After performing the bleaching procedure respective desensitizing agent was applied to each group for 10 minutes. Visual analogue scale and Schiff's scale were used to assess the sensitivity after completion of treatment. Subjective non stimulated assessment of sensitivity was done by using the visual analogue scale from day 1 till day 7 on given Performa and Objective stimulated assessment of sensitivity was done at the dental office on day 1 right after the procedure and at day 7 on follow-up after one week.
Statistical analysis was carried out by using the software SPSS IBM version 26.Median and inter quartile range (IQR) were reported to describe continuous variables (pain and sensitivity score) Normality of continuous variable (VAS pain score and sensitivity score) was checked by using the Shapiro-wilk test and Kruskal-Wallis test was applied to check median pain score and sensitivity difference between the groups. Mann-Whitney U test was applied to check further pairwise comparison between the groups. Chi-squire test was applied and cross tabulation done to see the association between all groups and visual analog scale. P-values of less than or equal to ≤ 0.05 were used to determine the significance of all test results.
- Conditions
- Post Operative Pain
- Being tested
- Propolis, hydrogen peroxide 35%, fluoride varnish
- Keywords
- Tooth discoloration, vital tooth bleaching, dentine hypersensitivity, desensitizing agent, Propolis, Vital tooth bleaching
- Medical subject headings
- Pain, Postoperative, Tooth Discoloration, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropolisDrug
Vital tooth bleaching will be performed and Propolis as a desensitizing agent will be applied after bleaching to reduce dentine hypersensitivity.
hydrogen peroxide 35%Drug
hydrogen peroxide 35%
fluoride varnishOther
fluoride varnish
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | One visit three application of bleaching agent (hydrogen peroxide 35%) will be performed and desensitizing agent (fluoride varnish) will be applied for 10 minutes after bleaching. Receives: Drug: hydrogen peroxide 35%; Other: fluoride varnish |
| Propolis | Experimental | One sitting vital tooth bleaching procedure will be performed. Three application each of 15 minutes of bleaching agent (hydrogen peroxide 35%) will be applied and desensitizing agent propolis in paste form will be applied for 10 minutes. Receives: Drug: Propolis; Drug: hydrogen peroxide 35% |
| Propolis mixed with bleaching agent | Experimental | One visit vital tooth bleaching procedure will be performed. three application each of 15 minutes of Propolis mixed with bleaching agent (hydrogen peroxide 35%) will be applied. Receives: Drug: Propolis; Drug: hydrogen peroxide 35% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of efficacy of desensitizing agent Propolis after an in office vital tooth bleaching
Visual analogue scale (VAS) was used to assess the postoperative dentine hypersensitivity after procedure. Performa was provided to the patients which include VAS. the scale is usually a straight line 10 cm line which clearly defined boundries 0= no pain,1-3=mild pain,4-6 moderate pain and 7-10 severe pain.patients marked the no according to their pain ( sensitivity) level.
Measured: Post operative sensitivity was assessed for 7 days after treatment. Visual analogue scale was used to assess the pain (sensitivity).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start14 May 2021
- Primary completion25 Dec 2021
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects are randomly placed into one of the groups: Control, Propolis and Propolis mixed with bleaching agent. In Propolis group Propolis paste will be applied for 10 minutes. Post operative sensitivity will be assessed for 7 days by using visual analogue and Shiff's scale.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Soomro, Dow University of Health Sciences
- Investigators
- Fatima Soomro, MDS, Principal investigator, DUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569590
- Sponsor's protocol ID
- FSoomro
- Status last verified
- Oct 2022
- First submitted
- 28 Sep 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effiacacy of Desensitizing Agent,After an In-office Vital Tooth Bleaching. A Randomized Double Blind Clinical Trial Trial.
- ClinicalTrials.gov ID
- NCT05569590
- Acronym / sponsor ID
- FSoomro
- Conditions
- Post Operative Pain
- Keywords
- Tooth discoloration, vital tooth bleaching, dentine hypersensitivity, desensitizing agent, Propolis, Vital tooth bleaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 14 May 2021 (actual)
- Primary completion
- 25 Dec 2021 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 6 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.
This study was conducted to evaluate the efficacy of desensitizing agent Propolis, after an in -office vital tooth bleaching and to compare its desensitizing effect to traditionally used desensitizing agent fluoride varnish.
Methods: Considering the inclusion and exclusion criteria 90 patients will be selected at the OPD of Dow University of Health Sciences Ojha campus with mild to moderate discoloration and randomly divided in to three groups group A control group (fluoride varnish) group B Propolis and group C Propolis mixed with bleaching agent. After performing the bleaching procedure respective desensitizing agent was applied to each group for 10 minutes. Visual analogue scale and Schiff's scale were used to assess the sensitivity after completion of treatment. Subjective non stimulated assessment of sensitivity was done by using the visual analogue scale from day 1 till day 7 on given Performa and Objective stimulated assessment of sensitivity was done at the dental office on day 1 right after the procedure and at day 7 on follow-up after one week.
Kruskal-Wallis test was applied to check median pain score and sensitivity difference between and among the groups. Mann-Whitney U test was applied to check further pairwise comparison between the groups.
Detailed description
Dental aesthetic is one of the great importance to the patients, various causes of tooth discoloration which usually encountered are dental fluorosis, aging, staining, smoking, medication use, etc. Different treatment options are available to treat discoloration depends on the individual case. Dental bleaching is one of the most conservative, noninvasive, low cost effective treatment modality to treat discoloration. In vital tooth bleaching dentists use 35 to 38 % hydrogen peroxide which have the deleterious effects on tooth structures. The main problem which is usually experienced by the patients with the vital tooth bleaching is dentine hypersensitivity. Methods: Considering the inclusion and exclusion criteria 90 patients will be selected at the OPD of Dow University of Health Sciences Ojha campus with mild to moderate discoloration and randomly divided in to three groups group A control group (fluoride varnish) group B Propolis and group C Propolis mixed with bleaching agent. After performing the bleaching procedure respective desensitizing agent was applied to each group for 10 minutes. Visual analogue scale and Schiff's scale were used to assess the sensitivity after completion of treatment. Subjective non stimulated assessment of sensitivity was done by using the visual analogue scale from day 1 till day 7 on given Performa and Objective stimulated assessment of sensitivity was done at the dental office on day 1 right after the procedure and at day 7 on follow-up after one week.
Statistical analysis was carried out by using the software SPSS IBM version 26.Median and inter quartile range (IQR) were reported to describe continuous variables (pain and sensitivity score) Normality of continuous variable (VAS pain score and sensitivity score) was checked by using the Shapiro-wilk test and Kruskal-Wallis test was applied to check median pain score and sensitivity difference between the groups. Mann-Whitney U test was applied to check further pairwise comparison between the groups. Chi-squire test was applied and cross tabulation done to see the association between all groups and visual analog scale. P-values of less than or equal to ≤ 0.05 were used to determine the significance of all test results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects are randomly placed into one of the groups: Control, Propolis and Propolis mixed with bleaching agent. In Propolis group Propolis paste will be applied for 10 minutes. Post operative sensitivity will be assessed for 7 days by using visual analogue and Shiff's scale.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: hydrogen peroxide 35%, Other: fluoride varnishOne visit three application of bleaching agent (hydrogen peroxide 35%) will be performed and desensitizing agent (fluoride varnish) will be applied for 10 minutes after bleaching. |
| Propolis | Experimental | Drug: Propolis, Drug: hydrogen peroxide 35%One sitting vital tooth bleaching procedure will be performed. Three application each of 15 minutes of bleaching agent (hydrogen peroxide 35%) will be applied and desensitizing agent propolis in paste form will be applied for 10 minutes. |
| Propolis mixed with bleaching agent | Experimental | Drug: Propolis, Drug: hydrogen peroxide 35%One visit vital tooth bleaching procedure will be performed. three application each of 15 minutes of Propolis mixed with bleaching agent (hydrogen peroxide 35%) will be applied. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- • Presence of all anterior teeth with mild to moderate discoloration
- Exclusion Criteria:• Patients with any kind of restoration, calculus or heavy stain on study site
- Candidates with severe discoloration
- Gross pathology with in oral cavity
- The Presence of heavy stains or calculus on study sites.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PropolisVital tooth bleaching will be performed and Propolis as a desensitizing agent will be applied after bleaching to reduce dentine hypersensitivity. | Drug | Propolis, Propolis mixed with bleaching agent |
| hydrogen peroxide 35%hydrogen peroxide 35% | Drug | Control, Propolis, Propolis mixed with bleaching agent |
| fluoride varnishfluoride varnish | Other | Control |
Primary outcome
Assessment of efficacy of desensitizing agent Propolis after an in office vital tooth bleaching
Time frame: Post operative sensitivity was assessed for 7 days after treatment. Visual analogue scale was used to assess the pain (sensitivity).
Visual analogue scale (VAS) was used to assess the postoperative dentine hypersensitivity after procedure. Performa was provided to the patients which include VAS. the scale is usually a straight line 10 cm line which clearly defined boundries 0= no pain,1-3=mild pain,4-6 moderate pain and 7-10 severe pain.patients marked the no according to their pain ( sensitivity) level.
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 6 Oct 2022.
- 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.
Fatima Soomro, MDS principal investigator
DUHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propolis, hydrogen peroxide 35% and fluoride varnish in people with Post Operative Pain, 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 13 inclusion and 0 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 6 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 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?
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?
Assessment of efficacy of desensitizing agent Propolis after an in office vital tooth bleaching (time frame: Post operative sensitivity was assessed for 7 days after treatment. Visual analogue scale was used to assess the pain (sensitivity).). 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 6 Oct 2022.