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

Primary Purpose

Periodontal Disease, Dentin Sensitivity

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

manual and ultrasonic instruments

About this trial

This is an interventional treatment trial for Periodontal Disease focused on measuring Dentin sensitivity, Dental scaling, Ultrasonic, manual and ultrasonic instrumentation

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Change in the clinical attachment level

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.

Full Information

NCT ID

NCT01427764

First Posted

August 24, 2011

Last Updated

August 31, 2011

Sponsor

Escola Bahiana de Medicina e Saude Publica

1. Study Identification

Unique Protocol Identification Number

NCT01427764

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Escola Bahiana de Medicina e Saude Publica

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Disease, Dentin Sensitivity

Keywords

Dentin sensitivity, Dental scaling, Ultrasonic, manual and ultrasonic instrumentation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

manual and ultrasonic instruments

Intervention Description

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 ®).

Secondary Outcome Measure Information:

Title

Change in the clinical attachment level

Description

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.

Time Frame

baseline and 4 weeks follow after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

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

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