NCT01091909

Brief Summary

The purpose of this study is to evaluate clinical healing after dental extraction and the occurrence of surgical complications in patients with type 2 diabetes and compare with non-diabetic patients or control, taking into account laboratory data such as blood count, glycated hemoglobin (HbA1) and immunological profile of the patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 17, 2014

Status Verified

July 1, 2014

Enrollment Period

3.2 years

First QC Date

March 23, 2010

Last Update Submit

July 16, 2014

Conditions

Type 2 Diabetes

Keywords

type 2 diabeteswound healingneutrophil countdental extraction

Outcome Measures

Primary Outcomes (1)

  • postoperative complications

    Postoperative complications included the following signs and symptoms: edema; erythema; alveolar bone exposure; halitosis; trismus; fever; cellulitis; Ludwig's angina; loss of appetite; malaise; itching; moderate pain (as assessed by a visual analog scale); and unpleasant taste.

    3, 7, 21, and 60 postoperative days

Secondary Outcomes (1)

  • Delayed wound healing

    3, 7, 21, and 60 postoperative days

Study Arms (1)

post-extraction wound healing

EXPERIMENTAL

53 individuals with diabetes and 29 controls, without diabetes, were followed for 60 days after dental extractions, and were examined after 3, 7, 21, and 60 postoperative days.

Procedure: Dental extractions

Interventions

Dental extractionsPROCEDURE

All dental extractions were performed at an outpatient clinic at the USP Dental School. In addition, all extractions were performed under local anesthesia by the same experienced dentist, in accordance with the standards established by Peterson et al (2008).

post-extraction wound healing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients will be treated at the dental clinic of CAPE-FOUSP (Special Care Dentistry Center, School of Dentistry, University of São Paulo), and will be selected for the study when they require simple extraction of the first or second lower molar.

You may not qualify if:

  • Patients that will be excluded from both groups are those who come to the clinic in an emergency dental situation, those who are using (or have used within one month previous) hormones, antibiotics, anti-inflammatory drugs, bisphosphonates, smokers, drug users and chronic alcohol users. Patients with thyroid disorders and those who are unable to measure capillary blood glucose at home will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry of University of São Paulo

São Paulo, São Paulo, 055508-000, Brazil

Location

Related Publications (2)

  • Barasch A, Safford MM, Litaker MS, Gilbert GH. Risk factors for oral postoperative infection in patients with diabetes. Spec Care Dentist. 2008 Jul-Aug;28(4):159-66. doi: 10.1111/j.1754-4505.2008.00035.x.

    PMID: 18647376BACKGROUND

  • Bergman SA. Perioperative management of the diabetic patient. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Jun;103(6):731-7. doi: 10.1016/j.tripleo.2006.11.029. Epub 2007 Mar 26.

    PMID: 17376713BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Tooth Extraction

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Study Officials

  • Marina Gallottini, PhD

    Head of the Special Care Dentistry Center of Dental School of University of Sao Paulo

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 24, 2010

Study Start

March 1, 2010

Primary Completion

May 1, 2013

Study Completion

June 1, 2014

Last Updated

July 17, 2014

Record last verified: 2014-07

Locations

BR(1)