Post Extraction Wound Healing in Patients With Diabetes (PEWHPD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Sao Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01091909
First received: March 23, 2010
Last updated: September 17, 2012
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Wound Healing
Diabetes
Metabolic Control
Procedure: surgery
Phase 0

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Post Extraction Wound Healing in Patients With Diabetes

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Estimated Enrollment: 120
Study Start Date: March 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
diabetics patients Procedure: surgery
teeth extraction
non-diabetic patients Procedure: surgery
teeth extraction

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

90 patients 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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091909

Locations
Brazil
School of Dentistry of University of São Paulo
São Paulo, SP, Brazil, 055508-000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
  More Information

Publications:
Responsible Party: Marina Helena Cury Gallottini de Magalhães, School of Detistry of University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01091909     History of Changes
Other Study ID Numbers: FR- 225568
Study First Received: March 23, 2010
Last Updated: September 17, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
diabetes
healing
neutrophil
alveolar repair

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 23, 2014