Periodontitis Chronic Generalized ModerateT2DNCT06895980
Effect of Periodontal Treatment on Metabolic Control in Patients with Type-2 Diabetes Mellitus Treated in the Cardiovascular Healt Program
A study testing Non-surgical periodontal treatment, glycated hemoglobin measurement and application of OHIP-14SP survey. in people with Periodontitis Chronic Generalized Moderate and Periodontitis, run by University of Chile at 1 site in Chile.
Trial summary
The objective of this clinical trial is to evaluate the effect of periodontal treatment on the reduction of glycated hemoglobin levels in adult patients with concurrent type 2 diabetes mellitus and periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis Chronic Generalized Moderate, Periodontitis, Periodontal Disease
- What is being tested?
- Non-surgical periodontal treatment, glycated hemoglobin measurement and application of OHIP-14SP survey.
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChile
- Study dates
- 22 Aug 2023to 31 Dec 2025
- 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
- 1a. Patients enrolled in the PSCV with a diagnosis of type 2 diabetes mellitus and who, in turn, have a glycated hemoglobin ≥ 7% (during the last 6 months).
- 1b. Patients with a diagnosis of periodontitis (≥ 2 non-adjacent teeth with detectable clinical interproximal attachment loss or, attachment loss ≥ 3mm with depth to probing ≥ 3mm on free faces of ≥ 2 teeth, where the attachment loss was not attributed to non-periodontal causes (Papapanou et al., 2018)).
Who cannot join
- 2a. Patients who have received periodontal treatment during the last year.
- 2b. Pregnancy/lactation, because they are under treatment under the Explicit Health Guarantee "Oral and Integral Health of Pregnant Women".
- 2c. Therapy with antibiotics and/or non-steroidal anti-inflammatory drugs (NSAIDs) in the last 6 months prior to the study.
Trial locations and contacts
1 site in 1 country.
Jorge Gamonal, Specialist in periodontics contact
Chile1 site, 1 recruiting
- Recruiting
Universidad de Chile
Santiago, Providencia
Melisa Vera Melisa Vera DSD, +56979660028, mvera@odontologia.uchile.cl
About this study
The objective of this clinical trial is to evaluate the effect of periodontal treatment on the reduction of glycated hemoglobin levels in adult patients with concurrent type 2 diabetes mellitus and periodontitis.
Non-surgical periodontal treatment and the application of a quality of life survey will be performed and then controls will be carried out for 1 year.
Read the detailed description
The aim of this clinical trial is to evaluate the effect of periodontal treatment on the reduction of HbA1c levels in adult patients with type 2 diabetes mellitus who are users of the Cardiovascular Health Program and also to measure their quality of life by means of a survey OHIP-14sp.
Non-surgical periodontal treatment and subsequent follow-up of periodontal clinical parameters and HbA1c values at 3, 6, 9 and 12 months will be performed.
- Conditions
- Periodontitis Chronic Generalized Moderate, Periodontitis, Periodontal Disease, Diabetes Mellitus Type 2
- Being tested
- Non-surgical periodontal treatment, glycated hemoglobin measurement and application of OHIP-14SP survey.
- Keywords
- HbA1c, Periodontitis, Cardiovascular diseases, Diabetes mellitus, type 2 diabetes mellitus, scaling and root planing
- Medical subject headings
- Periodontitis, Periodontal Diseases, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatment, glycated hemoglobin measurement and application of OHIP-14SP survey.Procedure or surgery
Non-surgical periodontal treatment will be performed, with periodontal maintenance therapy at 3, 6, 9 and 12 months, with measurement of glycated hemoglobin at each time and application of the OHIP-14SP oral health-related quality of life survey.
| Study group | Role | What they receive |
|---|---|---|
| Patients with periodontitis and Diabetes Mellitus type 2 | Experimental | There will be a group of patients to intervene, who present periodontitis and Diabetes Mellitus type 2. Receives: Procedure: Non-surgical periodontal treatment, glycated hemoglobin measurement and application of OHIP-14SP survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (The glycated hemoglobin)
The glycated hemoglobin (HbA1c) is a blood test that measures the average blood glucose level over the past two to three months, expressed as a percentage. It is used to diagnose diabetes and prediabetes, and to monitor diabetes treatment.
A higher percentage indicates poorer glycemic control. The value will be measured at the beginning of periodontal treatment and during maintenance therapy at 3, 6, 9 and 12 months.
Measured: 13 months
Secondary outcomes (4)
Patient self-reported quality of life.
Use of the OHIP-14 survey questionnaire that assesses people's quality of life in relation to their oral health.
It is administered through questions that quantify the impact of oral disorders. It is based on 7 dimensions: physical pain, functional limitation, psychological discomfort, physical disability, psychological disability, and social disability.
Scores range from 0 to 56 and are obtained by summing the ordinal values of the 14 items. Higher scores indicate a worse quality of life, and lower scores indicate a better quality of life.
The Spanish version has been validated in older adults in Chile. We will apply the survey at the beginning of study and 12 months later.
Measured: 13 months
Probing deep in periodontal evaluation
Probing depth is the distance between the gingival margin and the bottom of the periodontal pocket. It is measured in millimeters using a periodontal probe.
It is measured at six points on each tooth. The probe is inserted parallel to the root surface in the periodontal pocket. It is moved around the gingival margin. In healthy areas, probing depth should not exceed 3 mm. Depths greater than 3.9 mm may indicate periodontal disease. We will administer this assessment at entry into the study and at 3, 6, 9, and 12 months.
Measured: 13 months
Clinical attachment loss in periodontal evaluation
Clinical attachment loss is the difference between the position of the gum and the probing depth.
It is measured at six points on each tooth using a periodontal probe. It is measured in millimeters.
It is classified according to defined stages:
Stage 1: 1 to 2 millimeters Stage 2: 2 to 3 millimeters Stages 3 and 4: 5 millimeters or more The assessment is performed at admission, and at 3, 6, 9, and 12 months.
Measured: 13 months
bleeding of probing in periodontal evaluation
Bleeding on probing is a clinical parameter that indicates inflammation in the connective tissue of the gums.
It is performed with a standardized periodontal probe. It is measured at six sites per tooth. It is a dichotomous variable, considered positive if bleeding occurs, or negative if no bleeding occurs.
A value of less than 10% bleeding from all sites is considered periodontal stability.
It will be assessed at admission and at 3, 6, 9, and 12 months.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start22 Aug 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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 Periodontitis Chronic Generalized ModerateStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal study of difference-in-difference
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MELISA VERA, University of Chile
- Investigators
- Melisa Vera, Specialist in periodontics, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895980
- Sponsor's protocol ID
- 2023/12
- Other IDs
- Gianina Cánnepa SPCH
- Acronym
- T2D
- Status last verified
- Sep 2024
- First submitted
- 13 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baeza M, Morales A, Cisterna C, Cavalla F, Jara G, Isamitt Y, Pino P, Gamonal J. Effect of periodontal treatment in patients with periodontitis and diabetes: systematic review and meta-analysis. J Appl Oral Sci. 2020 Jan 10;28:e20190248. doi: 10.1590/1678-7757-2019-0248. eCollection 2020.
PubMed 31939522Cobb CM. Clinical significance of non-surgical periodontal therapy: an evidence-based perspective of scaling and root planing. J Clin Periodontol. 2002 May;29 Suppl 2:6-16.
PubMed 12010523
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Periodontal Treatment on Metabolic Control in Patients with Type-2 Diabetes Mellitus Treated in the Cardiovascular Healt Program
- ClinicalTrials.gov ID
- NCT06895980
- Acronym / sponsor ID
- T2D / 2023/12
- Conditions
- Periodontitis Chronic Generalized Moderate, Periodontitis, Periodontal Disease, Diabetes Mellitus Type 2
- Keywords
- HbA1c, Periodontitis, Cardiovascular diseases, Diabetes mellitus, type 2 diabetes mellitus, scaling and root planing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Mar 2025 (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.
The objective of this clinical trial is to evaluate the effect of periodontal treatment on the reduction of glycated hemoglobin levels in adult patients with concurrent type 2 diabetes mellitus and periodontitis.
Non-surgical periodontal treatment and the application of a quality of life survey will be performed and then controls will be carried out for 1 year.
Detailed description
The aim of this clinical trial is to evaluate the effect of periodontal treatment on the reduction of HbA1c levels in adult patients with type 2 diabetes mellitus who are users of the Cardiovascular Health Program and also to measure their quality of life by means of a survey OHIP-14sp.
Non-surgical periodontal treatment and subsequent follow-up of periodontal clinical parameters and HbA1c values at 3, 6, 9 and 12 months will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal study of difference-in-difference
| Arm | Type | Receives |
|---|---|---|
| Patients with periodontitis and Diabetes Mellitus type 2 | Experimental | Procedure: Non-surgical periodontal treatment, glycated hemoglobin measurement and application of OHIP-14SP survey.There will be a group of patients to intervene, who present periodontitis and Diabetes Mellitus type 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1a. Patients enrolled in the PSCV with a diagnosis of type 2 diabetes mellitus and who, in turn, have a glycated hemoglobin ≥ 7% (during the last 6 months).
- 1b. Patients with a diagnosis of periodontitis (≥ 2 non-adjacent teeth with detectable clinical interproximal attachment loss or, attachment loss ≥ 3mm with depth to probing ≥ 3mm on free faces of ≥ 2 teeth, where the attachment loss was not attributed to non-periodontal causes (Papapanou et al., 2018)).
Key exclusion criteria (3 listed)
- 2a. Patients who have received periodontal treatment during the last year.
- 2b. Pregnancy/lactation, because they are under treatment under the Explicit Health Guarantee "Oral and Integral Health of Pregnant Women".
- 2c. Therapy with antibiotics and/or non-steroidal anti-inflammatory drugs (NSAIDs) in the last 6 months prior to the study.
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, glycated hemoglobin measurement and application of OHIP-14SP survey.Non-surgical periodontal treatment will be performed, with periodontal maintenance therapy at 3, 6, 9 and 12 months, with measurement of glycated hemoglobin at each time and application of the OHIP-14SP oral health-related quality of life survey. | Procedure or surgery | Patients with periodontitis and Diabetes Mellitus type 2 |
Primary outcome
HbA1c (The glycated hemoglobin)
Time frame: 13 months
The glycated hemoglobin (HbA1c) is a blood test that measures the average blood glucose level over the past two to three months, expressed as a percentage. It is used to diagnose diabetes and prediabetes, and to monitor diabetes treatment. A higher percentage indicates poorer glycemic control. The value will be measured at the beginning of periodontal treatment and during maintenance therapy at 3, 6, 9 and 12 months.
4 secondary outcomes
Patient self-reported quality of life.
Time frame: 13 months
Probing deep in periodontal evaluation
Time frame: 13 months
Clinical attachment loss in periodontal evaluation
Time frame: 13 months
bleeding of probing in periodontal evaluation
Time frame: 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Background: PubMed 31939522Baeza M, Morales A, Cisterna C, Cavalla F, Jara G, Isamitt Y, Pino P, Gamonal J. Effect of periodontal treatment in patients with periodontitis and diabetes: systematic review and meta-analysis. J Appl Oral Sci. 2020 Jan 10;28:e20190248. doi: 10.1590/1678-7757-2019-0248. eCollection 2020.
- Background: PubMed 12010523Cobb CM. Clinical significance of non-surgical periodontal therapy: an evidence-based perspective of scaling and root planing. J Clin Periodontol. 2002 May;29 Suppl 2:6-16.
- 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.
Jorge Gamonal, Specialist in periodontics contact
Melisa Vera, Specialist in periodontics principal investigator
University of 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 Non-surgical periodontal treatment, glycated hemoglobin measurement and application of OHIP-14SP survey. in people with Periodontitis Chronic Generalized Moderate and Periodontitis, run by University of 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Mar 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melisa Vera, Specialist in periodontics (+56976442451 ext. +569, mvera@odontologia.uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (The glycated hemoglobin) (time frame: 13 months). 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 NCT06895980, 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 26 Mar 2025.