Post-extraction Wound Healing in Patients With Type 2 Diabetes (PEWHPD)

July 16, 2014 updated by: Karin Sa Fernandes, University of Sao Paulo
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It has been established in scientific literature that patients with diabetes have a greater predisposition to oral complications and that oral infections may compromise their metabolic control. There is scant clinical evidence of a relationship between diabetes and an increased risk of infection after dental extractions. To our knowledge, no prospective longitudinal studies have been designed to prove this hypothesis.

The aim of this study is to evaluate clinical healing after dental extraction and the occurrence of surgical complications in patients with type 1 and 2 diabetes and compare with non-diabetic patients, taking into account laboratory data such as blood count, glycated hemoglobin (HbA1) and immunological profile of the patients.

Ninety patients shall be prospectively studied, divided into 3 groups: Group 1 will consist of 30 patients with uncontrolled type 2 diabetics patients, group 2 will consist of 30 controlled type 2 diabetics patients and group 3 composed of 30 non-diabetic patients (control group).

All patients will undergo extraction of erupted teeth, always carried out by the same dentist (MS).

A complete medical history and laboratory tests will be conducted for all patients including: glycated hemoglobin (HbA1), fasting glucose, complete blood count, platelets, prothrombin time (PT), partial thromboplastin time (PTT), immunoglobulins (IgA, IgG and IgM), CD3, CD4, CD8, testing of complement (C3, C4), dihydrorhodamine (DHR) oxidation, phagocytosis index test and neutrophil chemotaxis.

At the end of surgery, blood pressure and plasma glucose by finger prick will be measured again. Surgery characteristics will be recorded, such as: length of surgery time from anesthesia to sutures, whether forceps and/or lever were used, the need to use a flap approach, the number of vials of anesthetic used, and intra-ligament anesthesia.

The clinical assessment of healing will take place 3, 7, 21, and 60 days after surgery and will be performed by the same dentist who perform the surgeries (KSF), blinded to the group of the patient and laboratory exams. On these days, the region will be examined, photographed and will be applied to the Visual Analogic Scale (VAS).

On day 60 after surgery, the postoperative period will be classified as: 1) no complications or 2) with complications, according to Cheung et al 2001. The following situations will be considered as complications after dental extraction:

  1. Acute infection of the alveolus: pain, erythema, edema, purulent discharge and fever;
  2. Acute inflammation of the alveolus: pain, inflamed alveolar tissue, absence of pus and fever;
  3. Dry socket: persistent pain and exposure of the alveolar bone.

All this clinical information will determine the post-operative quality regarding the healing time and occurrence of infection and inflammation of the alveoli.

Data will be statistically analyzed in order for us to understand the pattern of healing and occurrence of complications after dental extraction in the studied groups. The data analyzed will include hematological data, immunological profile and the glycated hemoglobin of patients.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 055508-000
        • School of Dentistry of University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: post-extraction wound healing
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative complications
Time Frame: 3, 7, 21, and 60 postoperative days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delayed wound healing
Time Frame: 3, 7, 21, and 60 postoperative days
According to the literature, the dental alveolus is filled with blood clot and fibrin at 3 days after dental extraction; on postoperative day 7, the alveolus is filled with granulation tissue; on postoperative day 21, wound epithelialization is complete; and on postoperative day 60, alveolar bone formation can be observed on a dental radiographic image. Delayed wound healing was defined as a delay in any of the aforementioned events.
3, 7, 21, and 60 postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Study Chair: Marina Gallottini, PhD, Head of the Special Care Dentistry Center of Dental School of University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 23, 2010

First Submitted That Met QC Criteria

March 23, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Estimate)

July 17, 2014

Last Update Submitted That Met QC Criteria

July 16, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FR- 225568

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on Dental extractions

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe