Dentin SensitivityNCT04207450
Effect of Glutaraldehyde on Dentin Hypersensitivity After Non-surgical Periodontal Treatment
A study testing Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5% in people with Dentin Sensitivity, run by Universidade Federal do Para at 1 site in Brazil.
Trial summary
This randomized, placebo-controlled, triple-blind trial aims to evaluate the effect of glutaraldehyde associated or not with 37% phosphoric acid conditioning on dentin hypersensitivity reduction after non-surgical periodontal treatment, and its durability after 15 and 30 days. desensitizing treatment. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Mar 2019to 13 Dec 2019
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of gingival recession without or with periodontal pocket up to 5mm probing depth, which presented painful sensitivity response to tactile and evaporative stimuli.
Who cannot join
- Systemic diseases;
- Pulpitis;
- Carious lesions;
- Presence of restorations in selected teeth;
- Cracked enamel;
- Noncarious cervical lesions;
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- Use of medication with analgesics and/or anti-inflammatories;
- Pregnant or lactating women;
- Desensitizing treatment and periodontal treatment received during three months prior to study recruitment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Glutaraldehyde on Dentin Hypersensitivity After Non-surgical Periodontal Treatment: a Triple-blind Randomized Clinical Trial.
This randomized, placebo-controlled, triple-blind trial aims to evaluate the effect of glutaraldehyde associated or not with 37% phosphoric acid conditioning on dentin hypersensitivity reduction after non-surgical periodontal treatment, and its durability after 15 and 30 days. desensitizing treatment. Additionally, investigate the impact of these treatments on health-related quality of life. The investigators selected patients who, after scraping and planing procedures, presented at least 2 teeth meeting the following inclusion criteria: presence of gingival recession without or with a periodontal pocket up to 5mm probing depth, which presented painful sensitivity response to tactile stimulus. and evaporative. Subjects were randomized into 3 groups: Placebo Group (GP) - Placebo Gel application followed by Placebo solution (distilled water); GPG- Placebo Gel application followed by application 5% aqueous glutaraldehyde solution; GSG - Application of 37% phosphoric acid followed by 5% aqueous glutaraldehyde solution. The sensitivity of the dental elements was evaluated by pain stimuli (tactile and evaporative) with the aid of a Visual Analog Scale (VAS). A questionnaire was applied to patients with the objective of capturing psychosocial experiences, prior to treatment and one month after its completion, to assess the impact of desensitizing treatment on health-related quality of life. Data will be collected and appropriate statistical tests will be applied.
- Conditions
- Dentin Sensitivity
- Being tested
- Placebo gel, Placebo Gel + 5% Glutaraldehyde Aqueous Solution, Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%
- Keywords
- Clinical trials, Dentin Sensitivity, glutaraldehyde, Desensitizing agents
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo gelOther
Placebo gel application followed by placebo solution application (distilled water)
Placebo Gel + 5% Glutaraldehyde Aqueous SolutionOther
Placebo gel followed by 5% aqueous glutaraldehyde solution
Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%Other
37% phosphoric acid application followed by 5% aqueous glutaraldehyde solution
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Placebo Gel + Placebo Solution (Distilled Water) Receives: Other: Placebo gel |
| Placebo Gel + Glutaraldehyde (GPG) | Experimental | Placebo Gel + 5% Glutaraldehyde Aqueous Solution Receives: Other: Placebo Gel + 5% Glutaraldehyde Aqueous Solution |
| Phosphoric Acid + Glutaraldehyde (GAG) | Experimental | 37% Phosphoric Acid + Glutaraldehyde Aqueous Solution (GAG) Receives: Other: Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentin sensitivity
Evaluation of pain (dentin sensitivity) by applying tactile (exploratory probe pressure) and evaporative (air blast) stimuli on exposed dentin. Sensitivity will be measured using the Thomas Schiff scale from 0 to 3. Zero means absent dentin sensitivity and three means severe dentin sensitivity.
Measured: Immediately after the intervention
Secondary outcomes (1)
Dentin hypersensitivity experience questionnaire
A self-reported questionnaire was applied by the patients with the objective of capturing psychosocial experiences, previous treatment and one month after its completion, aiming to evaluate the impact of desensitizing treatment on health-related quality of life.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start15 Mar 2019
- Primary completion29 Nov 2019
- Study completion13 Dec 2019
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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Para
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecy Martins Silva, Universidade Federal do Para
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207450
- Sponsor's protocol ID
- UFPara-006
- Status last verified
- Apr 2020
- First submitted
- 16 Dec 2019
- Last updated
- 21 Apr 2020
- 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 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glutaraldehyde on Dentin Hypersensitivity After Non-surgical Periodontal Treatment: a Triple-blind Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04207450
- Acronym / sponsor ID
- UFPara-006
- Conditions
- Dentin Sensitivity
- Keywords
- Clinical trials, Dentin Sensitivity, glutaraldehyde, Desensitizing agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade Federal do ParaUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 20 Dec 2019 (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 randomized, placebo-controlled, triple-blind trial aims to evaluate the effect of glutaraldehyde associated or not with 37% phosphoric acid conditioning on dentin hypersensitivity reduction after non-surgical periodontal treatment, and its durability after 15 and 30 days. desensitizing treatment. Additionally, investigate the impact of these treatments on health-related quality of life. The investigators selected patients who, after scraping and planing procedures, presented at least 2 teeth meeting the following inclusion criteria: presence of gingival recession without or with a periodontal pocket up to 5mm probing depth, which presented painful sensitivity response to tactile stimulus. and evaporative. Subjects were randomized into 3 groups: Placebo Group (GP) - Placebo Gel application followed by Placebo solution (distilled water); GPG- Placebo Gel application followed by application 5% aqueous glutaraldehyde solution; GSG - Application of 37% phosphoric acid followed by 5% aqueous glutaraldehyde solution. The sensitivity of the dental elements was evaluated by pain stimuli (tactile and evaporative) with the aid of a Visual Analog Scale (VAS). A questionnaire was applied to patients with the objective of capturing psychosocial experiences, prior to treatment and one month after its completion, to assess the impact of desensitizing treatment on health-related quality of life. Data will be collected and appropriate statistical tests will be applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Other: Placebo gelPlacebo Gel + Placebo Solution (Distilled Water) |
| Placebo Gel + Glutaraldehyde (GPG) | Experimental | Other: Placebo Gel + 5% Glutaraldehyde Aqueous SolutionPlacebo Gel + 5% Glutaraldehyde Aqueous Solution |
| Phosphoric Acid + Glutaraldehyde (GAG) | Experimental | Other: Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%37% Phosphoric Acid + Glutaraldehyde Aqueous Solution (GAG) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Presence of gingival recession without or with periodontal pocket up to 5mm probing depth, which presented painful sensitivity response to tactile and evaporative stimuli.
Key exclusion criteria (9 listed)
- Systemic diseases;
- Pulpitis;
- Carious lesions;
- Presence of restorations in selected teeth;
- Cracked enamel;
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 |
|---|---|---|
| Placebo gelPlacebo gel application followed by placebo solution application (distilled water) | Other | Placebo Group |
| Placebo Gel + 5% Glutaraldehyde Aqueous SolutionPlacebo gel followed by 5% aqueous glutaraldehyde solution | Other | Placebo Gel + Glutaraldehyde (GPG) |
| Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%37% phosphoric acid application followed by 5% aqueous glutaraldehyde solution | Other | Phosphoric Acid + Glutaraldehyde (GAG) |
Primary outcome
Dentin sensitivity
Time frame: Immediately after the intervention
Evaluation of pain (dentin sensitivity) by applying tactile (exploratory probe pressure) and evaporative (air blast) stimuli on exposed dentin. Sensitivity will be measured using the Thomas Schiff scale from 0 to 3. Zero means absent dentin sensitivity and three means severe dentin sensitivity.
1 secondary outcome
Dentin hypersensitivity experience questionnaire
Time frame: Immediately after the intervention
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 21 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5% in people with Dentin Sensitivity, run by Universidade Federal do Para at 1 site in Brazil.
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 9 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 21 Apr 2020. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Dentin sensitivity (time frame: Immediately after the intervention). 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 21 Apr 2020.