NCT01427764

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 2, 2011

Completed
Last Updated

September 2, 2011

Status Verified

August 1, 2011

Enrollment Period

11 months

First QC Date

August 24, 2011

Last Update Submit

August 31, 2011

Conditions

Keywords

Dentin sensitivityDental scalingUltrasonicmanual and ultrasonic instrumentation

Outcome Measures

Secondary Outcomes (1)

  • Change in the clinical attachment level

    baseline and 4 weeks follow after treatment

Interventions

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 ®).

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontal DiseasesDentin Sensitivity

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD in Periodontics

Study Record Dates

First Submitted

August 24, 2011

First Posted

September 2, 2011

Study Start

February 1, 2009

Primary Completion

January 1, 2010

Study Completion

June 1, 2010

Last Updated

September 2, 2011

Record last verified: 2011-08