Type 2 Diabetes MellitusNCT01128374
The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 Diabetes
A study testing Periodontal Scaling and root planing in people with Type 2 Diabetes Mellitus and Periodontal Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Type 2 diabetes mellitus (T2DM) has become a significant pandemic with more than 7% of the population in the United States affected. Moreover, up to one-third of these individuals may not be aware of the diagnosis and, are not involved in treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Periodontal Disease
- What is being tested?
- Periodontal Scaling and root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 2012
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Diagnosed type 2 diabetes mellitus
- Existence of moderate to severe periodontitis as defined by the American Academy of Periodontology
- In good general health - able to undergo the proposed therapy without compromise to existing health
- Demonstrated ability to read and understand written Spanish or English without the aid of ad-hoc interpretation by a third party
- Demonstrated ability to understand the proposed therapy and possible outcome
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- Demonstrated willingness to comply with all protocol requirements as outlined in the informed consent document
- Willingness/ability to sign an informed consent document for their own inclusion in the study
- Hispanic origin as confirmed by patient records
Who cannot join
- Pregnancy at the time of enrollment (Pregnancy test is required for female study participants of child-bearing potential.)
- Use of antibiotics within last 3 months
- Immunocompromised health status
- Other medical conditions that represent a threat to life
- Osteoporosis
- Biphosphonates, corticosteroids or behavior alteration medications
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- Historical abuse of alcohol or drugs
- Use of cigarettes/tobacco products within the past 12 months
- Mental diseases
- Any other oral pathology that compromise the patient's medical status
- Diagnosed type 1 diabetes mellitus (Information will be obtained from the medical records)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center Houston, Dental Branch
Houston, Texas, 77030
About this study
Official title: The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 DiabetesS
Type 2 diabetes mellitus (T2DM) has become a significant pandemic with more than 7% of the population in the United States affected. Moreover, up to one-third of these individuals may not be aware of the diagnosis and, are not involved in treatment. In the Mexican-American population, prevalence rates may be up to 50%. Contributing factors such as poor education, low household income, language barriers and restricted access to medical services may increase this prevalence. The association between periodontal disease and diabetes has been well documented; however, interventional studies have resulted in conflicting conclusions on improvements in glycemic control following periodontal therapy.
Diabetes and periodontal disease share common pathways in pathogenesis, such as their polygenic nature and immunoregulatory dysfunction. To answer these questions, we, the investigators, propose this randomized controlled trial designed to elucidate how treatment of periodontal disease can be used for preventive and therapeutic purposes in a diabetic population as well as to study the role of IL-1 gene cluster polymorphisms as a risk factor for the presence of periodontitis in a Hispanic T2DM population. Our central hypothesis is that the Mexican-American T2DM population in Texas is at risk for an increased presence and severity of periodontal disease due to the presence of Il-1 gene cluster polymorphisms; furthermore we suggest that providing non-surgical periodontal therapy to this group will decrease the bacterial load associated with disease and as a consequence, will improve glycemic control as measured by HbA1c values. Our long-term goal is to study risk factors associated with the presence of periodontal disease and to understand how the treatment of periodontal disease can be used for preventive and therapeutic purposes in a Hispanic type 2 diabetic population.
- Conditions
- Type 2 Diabetes Mellitus, Periodontal Disease
- Being tested
- Periodontal Scaling and root planing
- Keywords
- Periodontal disease, Nonsurgical therapy, Type 2 Diabetes Mellitus, Bacterial burden, Gene polymorphisms
- Medical subject headings
- Diabetes Mellitus, Type 2, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal Scaling and root planingProcedure or surgery
Participants will be instructed to brush their teeth using the modified Bass toothbrushing technique; the use of interproximal hygiene aids such as proximal brush or dental floss will be included. A full mouth scaling and root planning will be performed in 2 appointments (2 hours each) with the use of local anesthesia (typically 2% lidocaine with 1:100,000 epinephrine). In the control group, this treatment will be performed after all the data and samples have been collected and will encompass the last 2visits. Periodontal scaling and root planning treatment has been defined by The American Academy of Periodontology (AAP) as the standard of care for patients with periodontal disease. An ultrasonic instrument, scalers and curettes will be utilized to remove calculus and obtain a smooth root surface. The experimental subjects will be appointed 1 week later to complete the scaling and root planning procedure
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Therapy Receives: Procedure: Periodontal Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c percentage
Measured: At baseline and 120 days after treatment
Secondary outcomes (2)
microbial burden
Measured: Baseline and 120 days after therapy
gene polymorphisms
Measured: 120 days after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Principal investigator, Isabel Gay, The University of Texas Health Science Center, Houston
- Investigators
- Isabel C Gay, DDS, MS, Principal investigator, University of Texas Health Science Center Dental BranchJames Katancik, DDS, PhD, Study chair, University of Texas Health Science Center at Houston Dental BranchGena Tribble, PhD, Study director, University of Texas Health science Center Houston Dental Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128374
- Sponsor's protocol ID
- UL1RR024148 (CTSA)
- Other IDs
- UL1RR024148
- Status last verified
- Jan 2013
- First submitted
- 20 May 2010
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gay IC, Tran DT, Cavender AC, Weltman R, Chang J, Luckenbach E, Tribble GD. The effect of periodontal therapy on glycaemic control in a Hispanic population with type 2 diabetes: a randomized controlled trial. J Clin Periodontol. 2014 Jul;41(7):673-80. doi: 10.1111/jcpe.12268. Epub 2014 Jun 1.
PubMed 24797222
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 DiabetesS
- ClinicalTrials.gov ID
- NCT01128374
- Acronym / sponsor ID
- UL1RR024148 (CTSA)
- Conditions
- Type 2 Diabetes Mellitus, Periodontal Disease
- Keywords
- Periodontal disease, Nonsurgical therapy, Type 2 Diabetes Mellitus, Bacterial burden, Gene polymorphisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- Jun 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 May 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.
Type 2 diabetes mellitus (T2DM) has become a significant pandemic with more than 7% of the population in the United States affected. Moreover, up to one-third of these individuals may not be aware of the diagnosis and, are not involved in treatment. In the Mexican-American population, prevalence rates may be up to 50%. Contributing factors such as poor education, low household income, language barriers and restricted access to medical services may increase this prevalence. The association between periodontal disease and diabetes has been well documented; however, interventional studies have resulted in conflicting conclusions on improvements in glycemic control following periodontal therapy.
Diabetes and periodontal disease share common pathways in pathogenesis, such as their polygenic nature and immunoregulatory dysfunction. To answer these questions, we, the investigators, propose this randomized controlled trial designed to elucidate how treatment of periodontal disease can be used for preventive and therapeutic purposes in a diabetic population as well as to study the role of IL-1 gene cluster polymorphisms as a risk factor for the presence of periodontitis in a Hispanic T2DM population. Our central hypothesis is that the Mexican-American T2DM population in Texas is at risk for an increased presence and severity of periodontal disease due to the presence of Il-1 gene cluster polymorphisms; furthermore we suggest that providing non-surgical periodontal therapy to this group will decrease the bacterial load associated with disease and as a consequence, will improve glycemic control as measured by HbA1c values. Our long-term goal is to study risk factors associated with the presence of periodontal disease and to understand how the treatment of periodontal disease can be used for preventive and therapeutic purposes in a Hispanic type 2 diabetic population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Procedure: Periodontal Scaling and root planingTherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years old
- Diagnosed type 2 diabetes mellitus
- Existence of moderate to severe periodontitis as defined by the American Academy of Periodontology
- In good general health - able to undergo the proposed therapy without compromise to existing health
- Demonstrated ability to read and understand written Spanish or English without the aid of ad-hoc interpretation by a third party
Key exclusion criteria (11 listed)
- Pregnancy at the time of enrollment (Pregnancy test is required for female study participants of child-bearing potential.)
- Use of antibiotics within last 3 months
- Immunocompromised health status
- Other medical conditions that represent a threat to life
- Osteoporosis
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 |
|---|---|---|
| Periodontal Scaling and root planingParticipants will be instructed to brush their teeth using the modified Bass toothbrushing technique; the use of interproximal hygiene aids such as proximal brush or dental floss will be included. A full mouth scaling and root planning will be performed in 2 appointments (2 hours each) with the use of local anesthesia (typically 2% lidocaine with 1:100,000 epinephrine). In the control group, this treatment will be performed after all the data and samples have been collected and will encompass the last 2visits. Periodontal scaling and root planning treatment has been defined by The American Academy of Periodontology (AAP) as the standard of care for patients with periodontal disease. An ultrasonic instrument, scalers and curettes will be utilized to remove calculus and obtain a smooth root surface. The experimental subjects will be appointed 1 week later to complete the scaling and root planning procedure | Procedure or surgery | intervention |
Primary outcome
HbA1c percentage
Time frame: At baseline and 120 days after treatment
2 secondary outcomes
microbial burden
Time frame: Baseline and 120 days after therapy
gene polymorphisms
Time frame: 120 days after enrolment
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 15 Jan 2013.
- Derived from this study: PubMed 24797222Gay IC, Tran DT, Cavender AC, Weltman R, Chang J, Luckenbach E, Tribble GD. The effect of periodontal therapy on glycaemic control in a Hispanic population with type 2 diabetes: a randomized controlled trial. J Clin Periodontol. 2014 Jul;41(7):673-80. doi: 10.1111/jcpe.12268. Epub 2014 Jun 1.
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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.
Isabel C Gay, DDS, MS principal investigator
University of Texas Health Science Center Dental Branch
James Katancik, DDS, PhD study chair
University of Texas Health Science Center at Houston Dental Branch
Gena Tribble, PhD study director
University of Texas Health science Center Houston Dental Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal Scaling and root planing in people with Type 2 Diabetes Mellitus and Periodontal Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 9 inclusion and 11 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 15 Jan 2013. 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 United States. 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?
HbA1c percentage (time frame: At baseline and 120 days after treatment). 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 NCT01128374, which also lists 1 linked publication.
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 15 Jan 2013.