Dentin Hypersensitivity Following Non-surgical Periodontal Therapy With Hand or Ultrasonic Instruments

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ERICA DEL PELOSO RIBEIRO, Escola Bahiana de Medicina e Saude Publica

ClinicalTrials.gov Identifier:

NCT01427764

First received: August 24, 2011

Last updated: August 31, 2011

Last verified: August 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	August 24, 2011
Last Updated Date	August 31, 2011
Start Date ^ICMJE	February 2009
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01427764 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 31, 2011)	Change in the clinical attachment level [ Time Frame: baseline and 4 weeks follow after treatment ] [ Designated as safety issue: No ] 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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Dentin Hypersensitivity Following Non-surgical Periodontal Therapy With Hand or Ultrasonic Instruments
Official Title ^ICMJE	Dentin Hypersensitivity Following Non-surgical Periodontal Therapy With Hand or Ultrasonic Instruments
Brief 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. 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Periodontal Disease Dentin Sensitivity
Intervention ^ICMJE	Device: manual and ultrasonic instruments 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 ®).
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	14
Completion Date	June 2010
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	35 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01427764
Other Study ID Numbers ^ICMJE	123456
Has Data Monitoring Committee	Not Provided
Responsible Party	ERICA DEL PELOSO RIBEIRO, Escola Bahiana de Medicina e Saude Publica
Study Sponsor ^ICMJE	Escola Bahiana de Medicina e Saude Publica
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Escola Bahiana de Medicina e Saude Publica
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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