Chronic PeriodontitisNCT04051866
Effectiveness of Non-surgical Periodontal Treatment on HbA1c Levels in a Patient With Type 2 Diabetes Mellitus
A study testing Non-surgical periodontal treatment: Scaling and root planing (SRP) and Oral hygiene instructions in people with Chronic Periodontitis and Diabetes Mellitus, Type 2, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
Trial summary
This study evaluates the effectiveness of an intervention, non-surgical periodontal treatment (SPR), in patients with poorly controlled type 2 diabetes mellitus and moderate-severe periodontal disease aimed at reducing HbA1c levels at 12 months compared with the usual practice in Primary Health Care. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Periodontitis, Diabetes Mellitus, Type 2
- What is being tested?
- Non-surgical periodontal treatment: Scaling and root planing (SRP) and Oral hygiene instructions
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 2 Dec 2022to 15 Dec 2023
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes (code CIAP-2 T90)
- With at least one determination of HbA1c in the last 3 months HbA1c> 7.5%
- No changes in hypoglycemic or insulin treatment in the last 3 months.
- With generalized moderate-severe chronic periodontal disease.
- Presence of at least 16 natural teeth.
- Informed consent.
Who cannot join
- Patients with basic systemic diseases with oral involvement (autoimmune diseases of oral involvement: oral lichen planus, lupus, pemphigus, pemphigoid)
- Limited life expectancy.
- Urgent diabetic complications in the 30 days prior to the study.
- They need extensive oral treatment: fistulous trajectories, cellulitis, pulpitis or other oral infections.
- Pregnant, with desire for pregnancy in the 12 months of study or breastfeeding.
- That they have received periodontal treatment in the last 6 months.
Show all 12Show fewer
- That they have received antibiotic and / or anti-inflammatory regimen continued at least in the last 4 weeks prior to the study (except low doses of acetylsalicylic acid).
- In treatment with corticosteroids or immunosuppressive drugs.
- On dialysis or risk of bleeding (anticoagulant treatment).
- Dependent on alcohol.
- Patients who require antibiotic prophylaxis for the realization of SPR.
- Patients with uncontrolled systemic diseases (with the exception of diabetes): cardiovascular, lung, liver, kidney disease in advanced stages or neoplasms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Non-surgical Periodontal Treatment on HbA1c Levels in a Patient With Type 2 Diabetes Mellitus in Primary Care: Randomized Clinical Trial
This study evaluates the effectiveness of an intervention, non-surgical periodontal treatment (SPR), in patients with poorly controlled type 2 diabetes mellitus and moderate-severe periodontal disease aimed at reducing HbA1c levels at 12 months compared with the usual practice in Primary Health Care.
Read the detailed description
Design: Pragmatic cluster randomized clinical trial with 12 months follow-up. Unit of randomization: dentist. Setting: Primary Health Care Centers in one Spanish region (Madrid) Population: Patients ≥ 35 years of age with moderate-severe periodontal disease and diagnosed with type 2 diabetes with por control (HbA1c > 7,5). N=288 patients (144 in each arm) will be recruited by dentist before randomization.
Intervention: Both groups will receive education on oral hygiene measures. The experimental group will receive the non-surgical periodontal treatment at the beginning of the study and the control group at the end of the study.
- Conditions
- Chronic Periodontitis, Diabetes Mellitus, Type 2
- Being tested
- Non-surgical periodontal treatment: Scaling and root planing (SRP), Oral hygiene instructions
- Keywords
- Dentist, Primary Health Care, Chronic Periodontitis, Diabetes Mellitus, Type 2, Root planing, Dental Scaling
- Medical subject headings
- Chronic Periodontitis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatment: Scaling and root planing (SRP)Procedure or surgery
Removal of dental plaque and dental calculus from the surface of a tooth, from the surface of a tooth apical to the gingival margin accumulated in periodontal pockets, or from the surface coronal to the gingival margin.
Oral hygiene instructionsOther
Education for individual health regarding peridontal disease and its association with diabetes, as well as oral hygiene instructions that include the modified Bass technique, use of interproximal brushes and dental floss
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Usual care (provided in Primary Health Care Centres) Oral hygiene instructions Receives: Other: Oral hygiene instructions |
| Intervention | Experimental | Usual care (provided in Primary Health Care Centres) Non-surgical periodontal treatment: Scaling and root planing (SRP) Oral hygiene instructions Receives: Procedure: Non-surgical periodontal treatment: Scaling and root planing (SRP); Other: Oral hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin A (HbA1c)
Products of non-enzymatic reactions between GLUCOSE and HEMOGLOBIN A, occurring as a minor fraction of the hemoglobin components of human erythrocytes. Glycated hemoglobin A is used as an index of the average blood sugar level over a lifetime of erythrocytes.
Glycated hemoglobin (A1C) goals in patients with diabetes should be tailored to the individual, balancing the demonstrated benefits with regard to prevention and delay in microvascular complications with the risk of hypoglycemia. A reasonable goal of therapy might be an A1C value of ≤7.0 percent for most medication-treated patients (using an assay aligned to the Diabetes Control and Complications Trial in which the upper limit of normal is 6.0 percent). Glycemic targets are generally set somewhat higher (eg, <8 percent) for older adult patients and those with comorbidities or a limited life expectancy and little likelihood of benefit from intensive therapy.
Measured: Change from baseline HbA1c score at 6 and 12 months
Secondary outcomes (10)
Probing depth
The measured distance from the free end of the gingival margin to the bottom of the periodontal pocket. Measurement in milimetres. Depths greater than 3 mm can be associated with "attachment loss" of the tooth to the surrounding alveolar bone, which is a characteristic found in periodontitis.
Measured: basal measurement, at 6 and 12 months
Glomerular filtration
The volume of water filtered out of plasma through glomerular capillary walls into Bowman's capsules per unit of time
Measured: basal measurement, at 6 and 12 months
Quality of life of patients: EuroQol 5D-5L questionnaire
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. Each of the 5 dimensions comprising the EQ-5D descriptive system is divided into 5 levels of perceived problems: 1: no problem. 2: slight problems 3: moderate problems. 4: severe problems. 5: extreme problems
Measured: Basal measurement, at 6 and 12 months
Physical activity (IPAQ questionnaire)
IPAQ was developed for comparable and valid measures of physical activity within and between countries, across various life domains. Three levels are proposed: Category 1: Low: This is the lowest level of physical activity. Those individuals who not meet criteria for categories 2 or 3 are considered low/inactive. Category 2: Moderate: Any one of the following 3 criteria:
- 3 or more days of vigorous activity of at least 20 minutes per day
- 5 or more days of moderate-intensity activity or walking of at least 30 minutes per day
- 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-min/week.
Category 3: High: Any one of the following 2 criteria:
- Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week
- 7 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-minutes/week
Measured: Basal measurement, at 6 and 12 months
Diet questionnaire (MEDAS)
The MEDAS is a 14-item questionnaire that asks participants to report the usual frequency of consumption or the amount consumed of 12 main components of MedDiet and two eating habits related to MedDiet. Each of the 14 items is scored 1 or 0, depending on whether the participants adhere to each MedDiet component or not. If these conditions were not met, an item was assigned a score of 0. The resulting MedDiet score of MEDAS varied from 0 to 14. Photographs of portions and portion sizes were used, as appropriate, to facilitate completion of MEDAS TOTAL SCORE: < 9 low adhesion; > = 9 good adhesion
Measured: Basal measurement, at 6 and 12 months
Therapeutic adherence questionnaire (Morisky-Green)
It consists of a series of four contrast questions with dichotomous answer (yes / no), which reflects the patient's behavior regarding compliance. It is intended to assess whether the patient adopts correct attitudes regarding the treatment for his illness; It is assumed that if the attitudes are incorrect, the patient is non-compliant. It has the advantage of providing information on the causes of the breach. The patient is considered as compliant if he answers the four questions correctly.
Measured: Basal measurement, at 6 and 12 months
Cost-utility
The calculation of benefits will be made in the form of QALYs accounting for the total profit in profits, measured with the EuroQol 5D-5L in the intervention group
Measured: At 12 months
Gingival Recession
Exposure of the root surface when the edge of the gum (GINGIVA) moves apically away from the crown of the tooth. Measurement in milimetres. Greater gingival recession can be associated with "attachment loss" of the tooth to the surrounding alveolar bone, which is a characteristic found in periodontitis.
Measured: basal measurement, at 6 and 12 months
Clinical attachment level
The distance from the cementoenamel junction to the bottom of the periodontal pocket. Measurement in millimetres. Greater clinical attachment level can be associated with "attachment loss" of the tooth to the surrounding alveolar bone, which is a characteristic found in periodontitis.
Measured: basal measurement, at 6 and 12 months
Gingival Probing bleeding
Measured as the percentage of sites with blood present at the probing (present: if it occurred within 30 seconds of the probing. Absent: if no bleeding occurred). Greater gingival probing bleeding can be associated with "Inflammation of gum tissue", which is a characteristic found in periodontitis.
Measured: basal measurement, at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start2 Dec 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Why it stopped: Due to a Cochrane review whose authors conclude that further trials evaluating periodontal treatment versus no treatment/usual care are unlikely to change the overall conclusion reached in this review.
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
- Model description
- The sample size has been calculated to estimate a difference of at least 0.4% units between groups in the change of HbA1c at 12 months. By means of a list of the patients assigned in the usual practice to each participating dentist, who meets the inclusion criteria, and they will be contacted in the resulting order after carrying out a randomization of each list. Once it has been confirmed that it meets the inclusion criteria and accepted the participation in it, a simple random assignment, with balanced groups, will be used, automatically implemented in the electronic data collection notebook. The intervention can not be masked, however the main result is measured through an analytical parameter (HbA1c), minimizing the possibility of information bias. To reduce the possible variability due to the different observers, a training and calibration session will be developed.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Madrid
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Juan Ignacio Ropero Pires, Gerencia de Atención Primaria, Madrid
- Investigators
- María Trinidad García Vázquez, Dentist, PhD, Principal investigator, Gerencia de Atención Primaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051866
- Sponsor's protocol ID
- CCI 20/18
- Status last verified
- Sep 2023
- First submitted
- 16 Jul 2019
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Non-surgical Periodontal Treatment on HbA1c Levels in a Patient With Type 2 Diabetes Mellitus in Primary Care: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04051866
- Acronym / sponsor ID
- CCI 20/18
- Conditions
- Chronic Periodontitis, Diabetes Mellitus, Type 2
- Keywords
- Dentist, Primary Health Care, Chronic Periodontitis, Diabetes Mellitus, Type 2, Root planing, Dental Scaling
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to a Cochrane review whose authors conclude that further trials evaluating periodontal treatment versus no treatment/usual care are unlikely to change the overall conclusion reached in this review.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- Study start
- 2 Dec 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 9 Aug 2019 (actual)
- 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.
This study evaluates the effectiveness of an intervention, non-surgical periodontal treatment (SPR), in patients with poorly controlled type 2 diabetes mellitus and moderate-severe periodontal disease aimed at reducing HbA1c levels at 12 months compared with the usual practice in Primary Health Care.
Detailed description
Design: Pragmatic cluster randomized clinical trial with 12 months follow-up. Unit of randomization: dentist. Setting: Primary Health Care Centers in one Spanish region (Madrid) Population: Patients ≥ 35 years of age with moderate-severe periodontal disease and diagnosed with type 2 diabetes with por control (HbA1c > 7,5). N=288 patients (144 in each arm) will be recruited by dentist before randomization.
Intervention: Both groups will receive education on oral hygiene measures. The experimental group will receive the non-surgical periodontal treatment at the beginning of the study and the control group at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The sample size has been calculated to estimate a difference of at least 0.4% units between groups in the change of HbA1c at 12 months. By means of a list of the patients assigned in the usual practice to each participating dentist, who meets the inclusion criteria, and they will be contacted in the resulting order after carrying out a randomization of each list. Once it has been confirmed that it meets the inclusion criteria and accepted the participation in it, a simple random assignment, with balanced groups, will be used, automatically implemented in the electronic data collection notebook. The intervention can not be masked, however the main result is measured through an analytical parameter (HbA1c), minimizing the possibility of information bias. To reduce the possible variability due to the different observers, a training and calibration session will be developed.
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Oral hygiene instructionsUsual care (provided in Primary Health Care Centres) Oral hygiene instructions |
| Intervention | Experimental | Procedure: Non-surgical periodontal treatment: Scaling and root planing (SRP), Other: Oral hygiene instructionsUsual care (provided in Primary Health Care Centres) Non-surgical periodontal treatment: Scaling and root planing (SRP) Oral hygiene instructions |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of type 2 diabetes (code CIAP-2 T90)
- With at least one determination of HbA1c in the last 3 months HbA1c> 7.5%
- No changes in hypoglycemic or insulin treatment in the last 3 months.
- With generalized moderate-severe chronic periodontal disease.
- Presence of at least 16 natural teeth.
Key exclusion criteria (12 listed)
- Patients with basic systemic diseases with oral involvement (autoimmune diseases of oral involvement: oral lichen planus, lupus, pemphigus, pemphigoid)
- Limited life expectancy.
- Urgent diabetic complications in the 30 days prior to the study.
- They need extensive oral treatment: fistulous trajectories, cellulitis, pulpitis or other oral infections.
- Pregnant, with desire for pregnancy in the 12 months of study or breastfeeding.
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 |
|---|---|---|
| Non-surgical periodontal treatment: Scaling and root planing (SRP)Removal of dental plaque and dental calculus from the surface of a tooth, from the surface of a tooth apical to the gingival margin accumulated in periodontal pockets, or from the surface coronal to the gingival margin. | Procedure or surgery | Intervention |
| Oral hygiene instructionsEducation for individual health regarding peridontal disease and its association with diabetes, as well as oral hygiene instructions that include the modified Bass technique, use of interproximal brushes and dental floss | Other | Control, Intervention |
Primary outcome
Glycated Hemoglobin A (HbA1c)
Time frame: Change from baseline HbA1c score at 6 and 12 months
Products of non-enzymatic reactions between GLUCOSE and HEMOGLOBIN A, occurring as a minor fraction of the hemoglobin components of human erythrocytes. Glycated hemoglobin A is used as an index of the average blood sugar level over a lifetime of erythrocytes. Glycated hemoglobin (A1C) goals in patients with diabetes should be tailored to the individual, balancing the demonstrated benefits with regard to prevention and delay in microvascular complications with the risk of hypoglycemia. A reasonable goal of therapy might be an A1C value of ≤7.0 percent for most medication-treated patients (using an assay aligned to the Diabetes Control and Complications Trial in which the upper limit of normal is 6.0 percent). Glycemic targets are generally set somewhat higher (eg, <8 percent) for older adult patients and those with comorbidities or a limited life expectancy and little likelihood of benefit from intensive therapy.
10 secondary outcomes
Probing depth
Time frame: basal measurement, at 6 and 12 months
Glomerular filtration
Time frame: basal measurement, at 6 and 12 months
Quality of life of patients: EuroQol 5D-5L questionnaire
Time frame: Basal measurement, at 6 and 12 months
Physical activity (IPAQ questionnaire)
Time frame: Basal measurement, at 6 and 12 months
Diet questionnaire (MEDAS)
Time frame: Basal measurement, at 6 and 12 months
Therapeutic adherence questionnaire (Morisky-Green)
Time frame: Basal measurement, at 6 and 12 months
Cost-utility
Time frame: At 12 months
Gingival Recession
Time frame: basal measurement, at 6 and 12 months
Clinical attachment level
Time frame: basal measurement, at 6 and 12 months
Gingival Probing bleeding
Time frame: basal measurement, at 6 and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: No
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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.
María Trinidad García Vázquez, Dentist, PhD principal investigator
Gerencia de Atención Primaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal treatment: Scaling and root planing (SRP) and Oral hygiene instructions in people with Chronic Periodontitis and Diabetes Mellitus, Type 2, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
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 6 inclusion and 12 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: withdrawn, as of the sponsor's last update on 14 Sep 2023. 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 Spain. 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 was withdrawn before enrolling participants, so there are no results.
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 A (HbA1c) (time frame: Change from baseline HbA1c score at 6 and 12 months). 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 14 Sep 2023.