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

NCT02953249 | Unknown

• 1 other identifier: 51979315.7.0000.0075
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Number of participants with abnormal laboratory values

  Within 30 days before the tooth extraction

• Adverse events that are related to the surgery

  up to 3 hours before surgery

• Salivary flow

  Before surgery with 5 minutes collection

• Epidermal Grow Factor (EGF)

  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)

• Radiographic analysis of bone repair

  Between day 7 and day 60 after tooth extraction

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• under 18 years old

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Dental School of University of Sao Paulo

São Paulo, São Paulo, 05508000, Brazil

RECRUITING

Biospecimen

Retention: NONE RETAINED

stimulated saliva

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marina HC Gallottini, Professor

  University of Sao Paulo, Lineu prestes Ave, 2227, Sao Paulo, Brazil

  STUDY CHAIR

Central Study Contacts

Marina HC Gallottini, Professor

CONTACT

+551130917894; mhcgmaga@usp.br

Talita Castro, MSc

CONTACT

+5511964977750; talita.correa@usp.br

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: November 2, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: May 1, 2019
• Last Updated: November 2, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)