Chronic PeriodontitisNCT02652026
Effect of Non-surgical Periodontal Treatment on HbA1c in Type 2 Diabetic Patients
A study testing Nonsurgical periodontal treatment and Dental Prophylaxis in people with Chronic Periodontitis and Type 2 Diabetes Mellitus, run by University of Barcelona.
Trial summary
The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM). This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Type 2 Diabetes Mellitus
- What is being tested?
- Nonsurgical periodontal treatment and Dental Prophylaxis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnostic of T2DM (diagnosed at least 1'5 years prior the study).
- Presence of generalized chronic periodontitis (With at least 9 teeth present and more than 30% of locations with probing depth (PD) and clinical attachment level (CAL) ≥4mm).
Who cannot join
- Patients who received antibiotics the last 15 days, or for a period longer than 10 days the last three months.
- Having received non-surgical periodontal treatment within the past 6 months.
- Pregnancy
- Significant change of medication for diabetes during the course of the study
- Evidence of other serious systemic disease (ASA III or IV) which may influence periodontal disease.
About this study
The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM). This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group, Control Group.
Read the detailed description
Background: Periodontitis and diabetes are both highly prevalent conditions, and the association between these two common diseases has been recognised by dental professionals for many years.
Aim: The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM).
Methods: This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group (TG) (Oral Hygiene Instructions (OHI) + scaling and root planing (RAR) using ultrasound device and Gracey curettes); Control Group (CG) (OHI + supragingival removal of plaque and calculus with ultrasonic device). CG patients receive salvage therapy if a significant worsening of their periodontal status and / or metabolic observed. Periodontal assesment (probing pocket depth (PPD), gingival index (GI), and plaque index (PI)) and systemic assesment (random blood sugar, glycosylated hemoglobin (HbA1C), and salivary cytokines) and bacterial asessment at baseline and 3, 6 months after treatment is performed. There will be a single examiner, blind and calibrated to improve reproducibility. The investigators' hypothesis is that non-surgical periodontal treatment reduces HbA1c, improving metabolic control in patients with DM
- Conditions
- Chronic Periodontitis, Type 2 Diabetes Mellitus
- Being tested
- Nonsurgical periodontal treatment, Dental Prophylaxis
- Keywords
- dental root planing and scaling, periodontal disease, type 2 diabetes mellitus, glycosylated hemoglobin A
- Medical subject headings
- Chronic Periodontitis, 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.
Nonsurgical periodontal treatmentProcedure or surgery
Also called Scaling and root planing
Full mouth debridement, which consisted of scaling and root planing (SRP), was done in a single visit using an ultrasonic scaler (SATELEC P5 Newtron XS, Acteon, Merignac, France) and Gracey curretes (Hu- Friedy, Chicago, USA).
Dental ProphylaxisProcedure or surgery
Also called Removal superficial plaque
Removal superficial plaque using an ultrasonic scaler (SATELEC P5 Newtron XS, Acteon, Merignac, France)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | The Treatment Group (TG) received full mouth debridement, which consisted of scaling and root planing (SRP), was done in a single visit using an ultrasonic scaler (SATELEC P5 Newtron, Acteon, Merignac, France) and Gracey curettes (Hu- Friedy, Chicago, USA).Also received Oral Hygienic Instructions Receives: Procedure: Nonsurgical periodontal treatment; Procedure: Dental Prophylaxis |
| Control Group | Active comparator | The Control Group (CG) received periodontal prophylaxis at baseline, by removal of supragingival deposits (plaque and calculus) with ultrasonic scaler. Also received Oral Hygienic Instructions Receives: Procedure: Dental Prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Serum levels glycosylated hemoglobin
Measured: Baseline and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startJun 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies 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
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, elisabet mauri i obradors, University of Barcelona
- Investigators
- Jose López-López, Phd, Study director, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652026
- Sponsor's protocol ID
- UBarcelona
- Status last verified
- Oct 2016
- First submitted
- 11 Jul 2015
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-surgical Periodontal Treatment on HbA1c in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02652026
- Acronym / sponsor ID
- UBarcelona
- Conditions
- Chronic Periodontitis, Type 2 Diabetes Mellitus
- Keywords
- dental root planing and scaling, periodontal disease, type 2 diabetes mellitus, glycosylated hemoglobin A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 11 Jan 2016 (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 main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM). This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group, Control Group.
Detailed description
Background: Periodontitis and diabetes are both highly prevalent conditions, and the association between these two common diseases has been recognised by dental professionals for many years.
Aim: The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM).
Methods: This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group (TG) (Oral Hygiene Instructions (OHI) + scaling and root planing (RAR) using ultrasound device and Gracey curettes); Control Group (CG) (OHI + supragingival removal of plaque and calculus with ultrasonic device). CG patients receive salvage therapy if a significant worsening of their periodontal status and / or metabolic observed. Periodontal assesment (probing pocket depth (PPD), gingival index (GI), and plaque index (PI)) and systemic assesment (random blood sugar, glycosylated hemoglobin (HbA1C), and salivary cytokines) and bacterial asessment at baseline and 3, 6 months after treatment is performed. There will be a single examiner, blind and calibrated to improve reproducibility. The investigators' hypothesis is that non-surgical periodontal treatment reduces HbA1c, improving metabolic control in patients with DM
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Procedure: Nonsurgical periodontal treatment, Procedure: Dental ProphylaxisThe Treatment Group (TG) received full mouth debridement, which consisted of scaling and root planing (SRP), was done in a single visit using an ultrasonic scaler (SATELEC P5 Newtron, Acteon, Merignac, France) and Gracey curettes (Hu- Friedy, Chicago, USA).Also received Oral Hygienic Instructions |
| Control Group | Active comparator | Procedure: Dental ProphylaxisThe Control Group (CG) received periodontal prophylaxis at baseline, by removal of supragingival deposits (plaque and calculus) with ultrasonic scaler. Also received Oral Hygienic Instructions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnostic of T2DM (diagnosed at least 1'5 years prior the study).
- Presence of generalized chronic periodontitis (With at least 9 teeth present and more than 30% of locations with probing depth (PD) and clinical attachment level (CAL) ≥4mm).
Key exclusion criteria (5 listed)
- Patients who received antibiotics the last 15 days, or for a period longer than 10 days the last three months.
- Having received non-surgical periodontal treatment within the past 6 months.
- Pregnancy
- Significant change of medication for diabetes during the course of the study
- Evidence of other serious systemic disease (ASA III or IV) which may influence periodontal disease.
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 |
|---|---|---|
| Nonsurgical periodontal treatmentAlso: Scaling and root planingFull mouth debridement, which consisted of scaling and root planing (SRP), was done in a single visit using an ultrasonic scaler (SATELEC P5 Newtron XS, Acteon, Merignac, France) and Gracey curretes (Hu- Friedy, Chicago, USA). | Procedure or surgery | Treatment Group |
| Dental ProphylaxisAlso: Removal superficial plaqueRemoval superficial plaque using an ultrasonic scaler (SATELEC P5 Newtron XS, Acteon, Merignac, France) | Procedure or surgery | Control Group, Treatment Group |
Primary outcome
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline and 6 months after intervention
Serum levels glycosylated hemoglobin
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 19 Oct 2016.
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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.
Jose López-López, Phd study director
University of Barcelona
Questions about this trial
What is this clinical trial studying?
A study testing Nonsurgical periodontal treatment and Dental Prophylaxis in people with Chronic Periodontitis and Type 2 Diabetes Mellitus, run by University of Barcelona.
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 2 inclusion and 5 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 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline in Glycosylated Hemoglobin (HbA1c) (time frame: Baseline and 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2016.