Periodontal DiseaseNCT01427764
Dentin Hypersensitivity Following Non-surgical Periodontal Therapy With Hand or Ultrasonic Instruments
A study testing manual and ultrasonic instruments in people with Periodontal Disease and Dentin Sensitivity, run by Escola Bahiana de Medicina e Saude Publica.
Trial summary
Periodontal instrumentation aims to remove plaque and calculus from the root surface. Both manual and ultrasonic instruments have been used for such decontamination; however, establishing a healthy periodontium can result in adverse effects, such as dentin hypersensitivity. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Dentin Sensitivity
- What is being tested?
- manual and ultrasonic instruments
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Jun 2010
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients diagnosed with chronic or aggressive periodontitis, according to the American Academy of Periodontology classification15, requiring non-surgical periodontal treatment in at least two quadrants. These quadrants should present two contralateral and homologous teeth in the incisor to premolar region with probing depth ≥ 5 mm and bleeding on probing on the buccal surface.
Who cannot join
- presence of systemic illness or medication use (six months preceding the research), which could influence the response to periodontal treatment,
- performance of periodontal treatment including subgingival instrumentation in the six months preceding the study,
- performance of treatment for dentin hypersensitivity in the three months previous to the study,
- presence of periapical or pulpal changes,
- being under orthodontic treatment,
- smoking and
- pregnancy.
About this study
Periodontal instrumentation aims to remove plaque and calculus from the root surface. Both manual and ultrasonic instruments have been used for such decontamination; however, establishing a healthy periodontium can result in adverse effects, such as dentin hypersensitivity. The aim of this study was to evaluate the effects of hand or ultrasonic instrumentation on dentin hypersensitivity in patients undergoing non-surgical periodontal treatment. For this controlled clinical trial of a "split mouth" design, 14 patients were selected with homologous teeth in the incisor to premolar region and probing depth ≥ 5 mm on the buccal aspect of the teeth. One side (control) was instrumented with hand instruments and the other side (test) with ultrasonic instruments. Dentin hypersensitivity was assessed in the baseline and during the follow 4 weeks after treatment, with a periodontal probe scratching the root surface and with an air jet. The patient's response was detected by a visual analog scale (VAS) of 10 cm.
- Conditions
- Periodontal Disease, Dentin Sensitivity
- Being tested
- manual and ultrasonic instruments
- Keywords
- Dentin sensitivity, Dental scaling, Ultrasonic, manual and ultrasonic instrumentation
- Medical subject headings
- Periodontal Diseases, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual and ultrasonic instrumentsDevice
The individuals were instructed regarding causes and consequences of periodontal disease as well as prevention techniques, including the sulcular brushing technique and flossing. The retention factors of plaque (caries cavities, excess supragingival restorations and calculus) were removed during the initial visits. Clinical parameters were initially assessed 30 days after initial therapy.
The quadrants were randomly assigned and a total of 28 teeth were examined and treated. One side was treated with Gracey curettes (Hu-Friedy™ - Chicago, IL, USA) - control group and the other side with ultrasonic instruments (Profi II Ceramic™, Dabi Atlante - Ribeirão Preto, São Paulo, Brazil) - the test group, using the tip for subgingival instrumentation Perio Sub (Dabi Atlante ®).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startFeb 2009
- Primary completionJan 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Bahiana de Medicina e Saude Publica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ERICA DEL PELOSO RIBEIRO, Escola Bahiana de Medicina e Saude Publica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427764
- Sponsor's protocol ID
- 123456
- Status last verified
- Aug 2011
- First submitted
- 24 Aug 2011
- Last updated
- 2 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dentin Hypersensitivity Following Non-surgical Periodontal Therapy With Hand or Ultrasonic Instruments
- ClinicalTrials.gov ID
- NCT01427764
- Acronym / sponsor ID
- 123456
- Conditions
- Periodontal Disease, Dentin Sensitivity
- Keywords
- Dentin sensitivity, Dental scaling, Ultrasonic, manual and ultrasonic instrumentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Escola Bahiana de Medicina e Saude PublicaUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 2 Sep 2011 (estimated)
- 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.
Periodontal instrumentation aims to remove plaque and calculus from the root surface. Both manual and ultrasonic instruments have been used for such decontamination; however, establishing a healthy periodontium can result in adverse effects, such as dentin hypersensitivity. The aim of this study was to evaluate the effects of hand or ultrasonic instrumentation on dentin hypersensitivity in patients undergoing non-surgical periodontal treatment. For this controlled clinical trial of a "split mouth" design, 14 patients were selected with homologous teeth in the incisor to premolar region and probing depth ≥ 5 mm on the buccal aspect of the teeth. One side (control) was instrumented with hand instruments and the other side (test) with ultrasonic instruments. Dentin hypersensitivity was assessed in the baseline and during the follow 4 weeks after treatment, with a periodontal probe scratching the root surface and with an air jet. The patient's response was detected by a visual analog scale (VAS) of 10 cm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed with chronic or aggressive periodontitis, according to the American Academy of Periodontology classification15, requiring non-surgical periodontal treatment in at least two quadrants. These quadrants should present two contralateral and homologous teeth in the incisor to premolar region with probing depth ≥ 5 mm and bleeding on probing on the buccal surface.
Key exclusion criteria (7 listed)
- presence of systemic illness or medication use (six months preceding the research), which could influence the response to periodontal treatment,
- performance of periodontal treatment including subgingival instrumentation in the six months preceding the study,
- performance of treatment for dentin hypersensitivity in the three months previous to the study,
- presence of periapical or pulpal changes,
- being under orthodontic treatment,
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 |
|---|---|---|
| manual and ultrasonic instrumentsThe individuals were instructed regarding causes and consequences of periodontal disease as well as prevention techniques, including the sulcular brushing technique and flossing. The retention factors of plaque (caries cavities, excess supragingival restorations and calculus) were removed during the initial visits. Clinical parameters were initially assessed 30 days after initial therapy. The quadrants were randomly assigned and a total of 28 teeth were examined and treated. One side was treated with Gracey curettes (Hu-Friedy™ - Chicago, IL, USA) - control group and the other side with ultrasonic instruments (Profi II Ceramic™, Dabi Atlante - Ribeirão Preto, São Paulo, Brazil) - the test group, using the tip for subgingival instrumentation Perio Sub (Dabi Atlante ®). | Device | – |
Primary outcome
Not reported in the source record.
1 secondary outcome
Change in the clinical attachment level
Time frame: baseline and 4 weeks follow after treatment
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 2 Sep 2011.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing manual and ultrasonic instruments in people with Periodontal Disease and Dentin Sensitivity, run by Escola Bahiana de Medicina e Saude Publica.
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 7 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 2 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
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 2 Sep 2011.