Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Wound Healing After Tooth Extraction in Individuals With Type 1 Diabetes Mellitus
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | May 2019 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Brazil | Dental School of University of Sao Paulo | Sao Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wound healing change after tooth extraction through epithelialization | 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. |
60 days after surgery | Yes |
Secondary | Number of participants with abnormal laboratory values | Participants with thrombocytopenia or deficiency in coagulation factors will be re-evaluated | Within 30 days before the tooth extraction | Yes |
Secondary | Adverse events that are related to the 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. | up to 3 hours before surgery | Yes |
Secondary | Salivary flow | It will be calculated the salivary flow with millimeter per minute, being the study group compared to control group | Before surgery with 5 minutes collection | Yes |
Secondary | Epidermal Grow Factor (EGF) | The EGF in stimulated saliva will be analyzed and compared between groups (pg/ml) | 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) | Yes |
Secondary | Radiographic analysis of bone repair | Evaluate the alveolar bone repair by grayscale concentration captured using the software ImageJ | Between day 7 and day 60 after tooth extraction | Yes |
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