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

Periodontal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427764
• Other study ID #: 123456
• Status: Completed
• Phase: N/A
• First received: August 24, 2011
• Last updated: August 31, 2011
• Start date: February 2009
• Est. completion date: June 2010

Study information

• Verified date: August 2011
• Source: Escola Bahiana de Medicina e Saude Publica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brasil: Ethics Comittee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dentin Sensitivity
• Gingival Diseases
• Hypersensitivity
• Periodontal Disease
• Periodontal Diseases

Intervention

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 ®).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Escola Bahiana de Medicina e Saude Publica

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	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.	baseline and 4 weeks follow after treatment	No