Diabetes Mellitus.FONIS12I2106NCT01904422
Periodontal Treatment in Non-controlled Type 2 Diabetes Mellitus Patients. Clinical Trial
A study testing conventional periodontal treatment in people with Diabetes Mellitus. and Chronic Periodontitis, run by Universidad de los Andes, Chile at 1 site in Chile.
Trial summary
Periodontitis is an infectious disease that destroys the tooth supporting tissues and triggers a local and systemic immune response. Type 2 Diabetes Mellitus (DM2) is a risk factor for periodontitis.Patients with DM2 and periodontitis have greater difficulty getting and maintaining an appropriate glycemic control. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes Mellitus., Chronic Periodontitis
- What is being tested?
- conventional periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChile
- Study dates
- Mar 2013to Dec 2015
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Decompensated type 2 diabetic patients (HbA1c ≥ 7% at last check).
- Minimum 12 teeth in the mouth.
- no history of surgical or nonsurgical periodontal treatment in the six months prior to baseline.
- not be involved in another clinical trial.
Who cannot join
- Patients with renal failure
- Patients with rheumatoid arthritis,
- Patients with heart disease.
- Patients with history of stroke or acute cardiovascular event in the 12 months prior to the start of the study.
- Patients with liver dysfunction
- Patients in state of pregnancy or planning pregnancy.
- Patients on medical treatment with systemic antibiotics in the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Intensive Periodontal Treatment as Compared to Conventional Periodontal Treatment on the Level of Glycosylated Hemoglobin in Patients With Decompensated Type 2 Diabetes Mellitus: Randomized Clinical Trial
Periodontitis is an infectious disease that destroys the tooth supporting tissues and triggers a local and systemic immune response. Type 2 Diabetes Mellitus (DM2) is a risk factor for periodontitis.Patients with DM2 and periodontitis have greater difficulty getting and maintaining an appropriate glycemic control. It has been reported an average decrease of 0.4% in glycosylated hemoglobin levels (HbA1c) in patients periodontally treated versus untreated. It is not has been established that periodontal treatment type in spaced sessions (multiple sessions over a period of 4 weeks) or rapid and intensive (2 sessions in 24 hours), has a greater impact on glycemic control in type 2 diabetes patients.
Objective: To evaluate the effectiveness of intensive periodontal treatment modality as compared with conventional on HbA1c level in periodontitis and DM2 decompensated patients.
Read the detailed description
It is proposed to conduct a clinical trial in 100 type 2 diabetic patients with poor glycemic control defined as a glycated hemoglobin (HbA1c) ≥ 7% at last check, with randomization stratified by referral center, with two parallel groups (1: 1). Diabetic patients are in treatment and control in Diabetes Polyclinic Medical Specialty Center of the University of the Andes or the medical polyclinic Joan Alsina in San Bernardo . All decompensated DM2 patients diagnosed with chronic periodontitis will receive periodontal treatment based on 2 different periodontal treatment modalities: the first and most traditional is by spaced sessions by quadrant in 1 weekly session (5 sessions). The second form of treatment corresponds to an intensive periodontal treatment, whole mouth in 24 hours.
All patients will be given an initial periodontal examination with manual north carolina periodontal probe, performed by a single operator previously calibrated.
Periodontal status will be determine according to the classification of Page and Eke (2007) and periodontal wound size (PISA) will be also determine. Also, will be measured inflammatory mediators and cytokines in both plasma and gingival crevicular fluid (GCF) by ELISA test. The data were entered into a medical record designed specifically for this study and the variables will be recorded prior and at 3 and 6 months after periodontal therapy.
- Conditions
- Diabetes Mellitus., Chronic Periodontitis
- Being tested
- conventional periodontal treatment
- Keywords
- Diabetes mellitus., Periodontitis, Periodontal treatment.
- Medical subject headings
- Diabetes Mellitus, Chronic Periodontitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional periodontal treatmentProcedure or surgery
Also called intensive periodontal treatment
| Study group | Role | What they receive |
|---|---|---|
| conventional periodontal treatment | Experimental | Treatment group by quadrant in five weeks. Patients in this group will receive periodontal treatment including plaque control instructions, supragingival and subgingival debridement and root planing. This treatment is done in 5 sessions with a periodicity of 1 session per week. In the first session patients will receive hygiene instruction and supragingival debridement performed with and ultrasonic device. In the following session, there will be done the scaling and root planing to one quadrant per session, using site specific hand curettes. In case of being partially edentulous patients will be implemented at least 3 teeth per quadrant in each session. Receives: Procedure: conventional periodontal treatment |
| Intensive periodontal treatment | Experimental | Intensive treatment group in 24 hours: Patients in this group will receive periodontal treatment including: plaque control instructions, supragingival and subgingival debridement and scaling and root planing. This treatment is carried out in 2 sessions within 24 hours. In the first session hygiene instruction and supragingival and scaling and root planing of the teeth in right side at the upper jaw and mandible will be performed. The implementation of each upper and lower hemiarcade will be made until the periodontist treating check manually the removal of all subgingival calculus deposit and feel the smoothness of the root surface. In the second session, there will be an identical procedure in the arch left. Receives: Procedure: conventional periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin (HbA1c)
Assess levels and relationship of HbA1c in peripheral blood and gingival crevicular fluid at baseline, 3 and 6 months after periodontal treatment in the group of patients treated by intensive and conventional periodontal treatment.
Measured: 2 years
Secondary outcomes (3)
C-reactive protein
Assess levels and relationship of C-reactive protein, in peripheral blood and gingival crevicular fluid at baseline, 3 and 6 months after periodontal treatment in the group of patients treated by intensive and conventional periodontal treatment .
Measured: 2 years
Interleukin-6 (IL-6)
Assess levels and relationship of IL-6 in peripheral blood and gingival crevicular fluid at baseline, 3 and 6 months after periodontal treatment in the group of patients treated by intensive and conventional treatment.
Measured: 2 years
Tumor Necrosis Factor (TNF)
Asses levels and relationship of TNF in peripheral blood and gingival crevicular fluid at baseline, 3 and 6 months after intensive and conventional periodontal treatment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2015
- Study completionDec 2015
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 Diabetes Mellitus.Studies of the same condition, open and under way.
- 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
- Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio Quintero, Universidad de los Andes, Chile
- Investigators
- Antonio J Quintero, DDS, Principal investigator, Universidad de los Andes, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904422
- Sponsor's protocol ID
- Universidad de los Andes
- Acronym
- FONIS12I2106
- Status last verified
- Dec 2015
- First submitted
- 14 Jul 2013
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Quintero AJ, Chaparro A, Quirynen M, Ramirez V, Prieto D, Morales H, Prada P, Hernandez M, Sanz A. Effect of two periodontal treatment modalities in patients with uncontrolled type 2 diabetes mellitus: A randomized clinical trial. J Clin Periodontol. 2018 Sep;45(9):1098-1106. doi: 10.1111/jcpe.12991. Epub 2018 Aug 16.
PubMed 30024030
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Intensive Periodontal Treatment as Compared to Conventional Periodontal Treatment on the Level of Glycosylated Hemoglobin in Patients With Decompensated Type 2 Diabetes Mellitus: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01904422
- Acronym / sponsor ID
- FONIS12I2106 / Universidad de los Andes
- Conditions
- Diabetes Mellitus., Chronic Periodontitis
- Keywords
- Diabetes mellitus., Periodontitis, Periodontal treatment.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Jul 2013 (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.
Periodontitis is an infectious disease that destroys the tooth supporting tissues and triggers a local and systemic immune response. Type 2 Diabetes Mellitus (DM2) is a risk factor for periodontitis.Patients with DM2 and periodontitis have greater difficulty getting and maintaining an appropriate glycemic control. It has been reported an average decrease of 0.4% in glycosylated hemoglobin levels (HbA1c) in patients periodontally treated versus untreated. It is not has been established that periodontal treatment type in spaced sessions (multiple sessions over a period of 4 weeks) or rapid and intensive (2 sessions in 24 hours), has a greater impact on glycemic control in type 2 diabetes patients.
Objective: To evaluate the effectiveness of intensive periodontal treatment modality as compared with conventional on HbA1c level in periodontitis and DM2 decompensated patients.
Detailed description
It is proposed to conduct a clinical trial in 100 type 2 diabetic patients with poor glycemic control defined as a glycated hemoglobin (HbA1c) ≥ 7% at last check, with randomization stratified by referral center, with two parallel groups (1: 1). Diabetic patients are in treatment and control in Diabetes Polyclinic Medical Specialty Center of the University of the Andes or the medical polyclinic Joan Alsina in San Bernardo . All decompensated DM2 patients diagnosed with chronic periodontitis will receive periodontal treatment based on 2 different periodontal treatment modalities: the first and most traditional is by spaced sessions by quadrant in 1 weekly session (5 sessions). The second form of treatment corresponds to an intensive periodontal treatment, whole mouth in 24 hours.
All patients will be given an initial periodontal examination with manual north carolina periodontal probe, performed by a single operator previously calibrated.
Periodontal status will be determine according to the classification of Page and Eke (2007) and periodontal wound size (PISA) will be also determine. Also, will be measured inflammatory mediators and cytokines in both plasma and gingival crevicular fluid (GCF) by ELISA test. The data were entered into a medical record designed specifically for this study and the variables will be recorded prior and at 3 and 6 months after periodontal therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional periodontal treatment | Experimental | Procedure: conventional periodontal treatmentTreatment group by quadrant in five weeks. Patients in this group will receive periodontal treatment including plaque control instructions, supragingival and subgingival debridement and root planing. This treatment is done in 5 sessions with a periodicity of 1 session per week. In the first session patients will receive hygiene instruction and supragingival debridement performed with and ultrasonic device. In the following session, there will be done the scaling and root planing to one quadrant per session, using site specific hand curettes. In case of being partially edentulous patients will be implemented at least 3 teeth per quadrant in each session. |
| Intensive periodontal treatment | Experimental | Procedure: conventional periodontal treatmentIntensive treatment group in 24 hours: Patients in this group will receive periodontal treatment including: plaque control instructions, supragingival and subgingival debridement and scaling and root planing. This treatment is carried out in 2 sessions within 24 hours. In the first session hygiene instruction and supragingival and scaling and root planing of the teeth in right side at the upper jaw and mandible will be performed. The implementation of each upper and lower hemiarcade will be made until the periodontist treating check manually the removal of all subgingival calculus deposit and feel the smoothness of the root surface. In the second session, there will be an identical procedure in the arch left. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Decompensated type 2 diabetic patients (HbA1c ≥ 7% at last check).
- Minimum 12 teeth in the mouth.
- no history of surgical or nonsurgical periodontal treatment in the six months prior to baseline.
- not be involved in another clinical trial.
Key exclusion criteria (7 listed)
- Patients with renal failure
- Patients with rheumatoid arthritis,
- Patients with heart disease.
- Patients with history of stroke or acute cardiovascular event in the 12 months prior to the start of the study.
- Patients with liver dysfunction
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 |
|---|---|---|
| conventional periodontal treatmentAlso: intensive periodontal treatment | Procedure or surgery | Intensive periodontal treatment, conventional periodontal treatment |
Primary outcome
Glycated hemoglobin (HbA1c)
Time frame: 2 years
Assess levels and relationship of HbA1c in peripheral blood and gingival crevicular fluid at baseline, 3 and 6 months after periodontal treatment in the group of patients treated by intensive and conventional periodontal treatment.
3 secondary outcomes
C-reactive protein
Time frame: 2 years
Interleukin-6 (IL-6)
Time frame: 2 years
Tumor Necrosis Factor (TNF)
Time frame: 2 years
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 16 Dec 2015.
- Derived from this study: PubMed 30024030Quintero AJ, Chaparro A, Quirynen M, Ramirez V, Prieto D, Morales H, Prada P, Hernandez M, Sanz A. Effect of two periodontal treatment modalities in patients with uncontrolled type 2 diabetes mellitus: A randomized clinical trial. J Clin Periodontol. 2018 Sep;45(9):1098-1106. doi: 10.1111/jcpe.12991. Epub 2018 Aug 16.
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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.
Antonio J Quintero, DDS principal investigator
Universidad de los Andes, Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional periodontal treatment in people with Diabetes Mellitus. and Chronic Periodontitis, run by Universidad de los Andes, Chile at 1 site in Chile.
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 4 inclusion and 7 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 16 Dec 2015. 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 Chile. 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?
Glycated hemoglobin (HbA1c) (time frame: 2 years). 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 NCT01904422, 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 16 Dec 2015.