Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Wound Healing After Tooth Extraction in Individuals With Type 1 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02953249
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Marina Helena Cury Gallottini, University of Sao Paulo

Brief Summary:

Dental treatment to individuals with diabetes mellitus, particularly type 1 diabetes (T1DM), has always represented a challenge to the dentist. The literature provides some scientific evidence showing that diabetes is a risk factor for the occurrence of oral opportunistic infections, abnormal bone metabolism and delay in tissue repair, but with varying degrees of evidence.

Hyperglycemia, as well as diabetes, are known as risk factor for post-surgical infections, so maintaining the glycemic control in the postoperative period has been standard to health care. However, there are few studies on the impact of the glycemic control in the repair process after tooth extractions. And, to our knowledge, there aren't evidences that infections resulting from oral surgery are more frequent in individuals with diabetes or that the antibiotics prophylaxis is needed for these individuals before invasive dental procedures.

Some prospective studies show that people with diabetes, especially type 2 (T2DM), do not exhibit higher frequency of complications in repair process after tooth extractions compared to healthy individuals without diabetes. Recently, the study conduct by Fernandes et al., 2015, found higher frequency of delay on epithelial covering of the alveolus after 21 days of tooth extraction in individuals with T2DM, comparing to a control group. Delay was not related to infection and on the day 60th after surgery, all alveolus were totally epithelized. One of the author's hypothesis for the delay in the alveolar epithelialization on the participants with T2DM was the possible reduction of Epithelial Grow Factor (EGF) in saliva of these individuals. Some studies already demonstrated the reduction in salivary detection of EGF in individuals with diabetes.

There aren't prospective studies in the literature at our disposal, that evaluated intraoperative complications of tooth extractions of teeth already erupted in individuals with T1DM, or even post tooth extraction healing and the chronology of epithelialization of the alveolus and its relation with the degree of salivary EGF.

The aim of this study is to evaluated the intraoperative events and the post- tooth extraction healing, regarding the chronology of the repairing events and the occurrence of postoperative complications in individuals with T1DM compared to a control group. Besides, this study intend to relate the time of complete epithelial covering of the alveolus with the EGF collected by whole stimulated saliva.


Condition or disease
Diabetes Mellitus, Type 1

  Show Detailed Description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 60 Days
Official Title: Wound Healing After Tooth Extraction in Individuals With Type 1 Diabetes Mellitus
Study Start Date : September 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Study group
The study group will include 30 subjects with type 1 diabetes mellitus who require extraction of 1 or more erupted teeth
Control group
The control group will include 30 healthy subjects, without diabetes mellitus, in need of tooth extraction



Primary Outcome Measures :
  1. Wound healing change after tooth extraction through epithelialization [ Time Frame: 60 days after surgery ]

    Evaluation of repair and possible complications of the surgical wound will be held in 4 different moments, on day 3, 7, 21 and 60 after surgery. These evaluation it will always be perform by the researcher, trained and calibrated. Will be observed signs and symptoms such as edema, erythema, bone exposure, fever, pain and analgesic need.

    The repair process will be considered late when the following events do not match the period considered normal: day 3- alveolus filled by blood clot and fibrin; day 7- alveolus filled with granulation tissue; day 21- complete epithelialization of the wound; day 60- alveolus exhibiting bone deposition, radiographically observed.



Secondary Outcome Measures :
  1. Number of participants with abnormal laboratory values [ Time Frame: Within 30 days before the tooth extraction ]
    Participants with thrombocytopenia or deficiency in coagulation factors will be re-evaluated

  2. Adverse events that are related to the surgery [ Time Frame: up to 3 hours before surgery ]
    Participants with diabetes mellitus who show moments before surgery hypoglycemia (under 100mg/dL), hyperglycemia (above 400mg/dL), hypertension or hypotension will be re-schedule.

  3. Salivary flow [ Time Frame: Before surgery with 5 minutes collection ]
    It will be calculated the salivary flow with millimeter per minute, being the study group compared to control group

  4. Epidermal Grow Factor (EGF) [ Time Frame: after the saliva collection of all participants the samples will be frozen at -80 Celsius degrees. The EGF of the samples will be analyzed by the end of all patients collection (after 1 years collection) ]
    The EGF in stimulated saliva will be analyzed and compared between groups (pg/ml)

  5. Radiographic analysis of bone repair [ Time Frame: Between day 7 and day 60 after tooth extraction ]
    Evaluate the alveolar bone repair by grayscale concentration captured using the software ImageJ


Biospecimen Retention:   None Retained
stimulated saliva


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study group will include 30 subjects with type 1 diabetes mellitus who require extraction of 1 or more erupted teeth
Criteria

Inclusion Criteria:

  • Individuals with type 1 diabetes mellitus for study group
  • Healthy individuals without diabetes mellitus for control group

Exclusion Criteria:

  • under 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953249


Contacts
Layout table for location contacts
Contact: Marina HC Gallottini, Professor +551130917894 mhcgmaga@usp.br
Contact: Talita Castro, MSc +5511964977750 talita.correa@usp.br

Locations
Layout table for location information
Brazil
Dental School of University of Sao Paulo Recruiting
Sao Paulo, SP, Brazil, 05508000
Contact: Marina Gallottini, PhD    11997578016    mhcgmaga@usp.br   
Contact: Gilmara Ribeiro, secretary    55 11 30917859    gilmara@usp.br   
Sub-Investigator: Talita Castro, MSc         
Sub-Investigator: Karin Fernandes, PhD         
Sub-Investigator: Rubens Caliento, MSc         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Layout table for investigator information
Study Chair: Marina HC Gallottini, Professor University of Sao Paulo, Lineu prestes Ave, 2227, Sao Paulo, Brazil

Additional Information:

Layout table for additonal information
Responsible Party: Marina Helena Cury Gallottini, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02953249     History of Changes
Other Study ID Numbers: 51979315.7.0000.0075
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases