- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01427764
Dentin Hypersensitivity Following Non-surgical Periodontal Therapy With Hand or Ultrasonic Instruments
August 31, 2011 updated by: ERICA DEL PELOSO RIBEIRO, Escola Bahiana de Medicina e Saude Publica
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the clinical attachment level
Time Frame: baseline and 4 weeks follow after treatment
|
Measured by a calibrated professional on baseline and 30 days after treatment - the distance from the cemental enamel junction to the bottom of the pocket.
|
baseline and 4 weeks follow after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
August 24, 2011
First Submitted That Met QC Criteria
August 31, 2011
First Posted (Estimate)
September 2, 2011
Study Record Updates
Last Update Posted (Estimate)
September 2, 2011
Last Update Submitted That Met QC Criteria
August 31, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 123456 (UMMashhad)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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