Type 2 DiabetesPEWHPDNCT01091909
Post-extraction Wound Healing in Patients With Type 2 Diabetes
A study testing Dental extractions in people with Type 2 Diabetes, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Dental extractions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry of University of São Paulo
São Paulo, São Paulo, 055508-000
About this study
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.
Read the 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:
- Acute infection of the alveolus: pain, erythema, edema, purulent discharge and fever;
- Acute inflammation of the alveolus: pain, inflamed alveolar tissue, absence of pus and fever;
- 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Dental extractions
- Keywords
- type 2 diabetes, wound healing, neutrophil count, dental extraction
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental extractionsProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| post-extraction wound healing | Experimental | 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. Receives: Procedure: Dental extractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
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.
Measured: 3, 7, 21, and 60 postoperative days
Secondary outcomes (1)
Delayed wound healing
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.
Measured: 3, 7, 21, and 60 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Karin Sa Fernandes, University of Sao Paulo
- Investigators
- Marina Gallottini, PhD, Study chair, Head of the Special Care Dentistry Center of Dental School of University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091909
- Sponsor's protocol ID
- FR- 225568
- Acronym
- PEWHPD
- Status last verified
- Jul 2014
- First submitted
- 23 Mar 2010
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Barasch A, Safford MM, Litaker MS, Gilbert GH. Risk factors for oral postoperative infection in patients with diabetes. Spec Care Dentist. 2008 Jul-Aug;28(4):159-66. doi: 10.1111/j.1754-4505.2008.00035.x.
PubMed 18647376Bergman SA. Perioperative management of the diabetic patient. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Jun;103(6):731-7. doi: 10.1016/j.tripleo.2006.11.029. Epub 2007 Mar 26.
PubMed 17376713
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-extraction Wound Healing in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01091909
- Acronym / sponsor ID
- PEWHPD / FR- 225568
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, wound healing, neutrophil count, dental extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Mar 2010
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Acute infection of the alveolus: pain, erythema, edema, purulent discharge and fever;
- Acute inflammation of the alveolus: pain, inflamed alveolar tissue, absence of pus and fever;
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post-extraction wound healing | Experimental | Procedure: Dental extractions53 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental extractionsAll 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). | Procedure or surgery | post-extraction wound healing |
Primary outcome
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.
1 secondary outcome
Delayed wound healing
Time frame: 3, 7, 21, and 60 postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
- Background: PubMed 18647376Barasch A, Safford MM, Litaker MS, Gilbert GH. Risk factors for oral postoperative infection in patients with diabetes. Spec Care Dentist. 2008 Jul-Aug;28(4):159-66. doi: 10.1111/j.1754-4505.2008.00035.x.
- Background: PubMed 17376713Bergman SA. Perioperative management of the diabetic patient. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Jun;103(6):731-7. doi: 10.1016/j.tripleo.2006.11.029. Epub 2007 Mar 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Gallottini, PhD study chair
Head of the Special Care Dentistry Center of Dental School of University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental extractions in people with Type 2 Diabetes, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications (time frame: 3, 7, 21, and 60 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01091909, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2014.