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Chronic PeriodontitisPhase 2NCT02643771

Clinical and Microbiological Evaluation of Periodontal Treatment of Diabetic Patients: A Longitudinal Study

A Phase 2 study testing Full Mouth Scaling and Root Planing in people with Chronic Periodontitis and Diabetes Mellitus, Type 2, run by Eduardo Aleixo Figueira at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine whether periodontal treatment improves the periodontal clinical parameters in the periodontal patients with diabetes regarding non-diabetics: two years follow-up. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Full Mouth Scaling and Root Planing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteBrazil
Study dates
Jan 2013to Oct 2017
Phase
Phase 2
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of chronical periodontitis according to Lopez et al. 2002 (one or more teeth with at least one site with PD >= 4mm or CAL >= 3mm);
  • And have at least 8 natural teeth (excluding third molars), and older than 18 years and of both genders.

Who cannot join

  • Any systemic diseases or complications (except Type 2 Diabetes Mellitus) such as cardiovascular disease, Alzheimer's, lung or brain diseases and metabolic syndrome;
  • Use of antibiotics or periodontal treatment within the past 6 months;
  • Long-term administration of anti-inflammatory or/and immunosuppressive agents;
  • Current smoker or former smoker for the past 5 years;
  • Pregnant or breastfeeding;
  • And presence of orthodontic appliances.

Trial locations and contacts

1 site in 1 country.

Bruno CV Gurgel, Doctor contact

+558432154136

bcgurgel@yahoo.com.br

Eduardo A Figueira, Doctor contact

+5584999521370

edufigueira@yahoo.com.br

Brazil1 site, 1 recruiting

  • Departamento de Odontologia; Universidade Federal do Rio Grande do Norte

    Natal, Rio Grande do Norte, 59056-000

    Bruno CV Gurgel, Doctor, +558432154136, bcgurgel@yahoo.com.br

    Eduardo A Figueira, Doctor, +5584999521370, edufigueira@yahoo.com.br

    Recruiting

Other trials in Brazil

About this study

Official title: Clinical and Microbiological Evaluation of Non-surgical Periodontal Treatment of Diabetic and Non-diabetic Patients: A Longitudinal Study

The purpose of this study is to determine whether periodontal treatment improves the periodontal clinical parameters in the periodontal patients with diabetes regarding non-diabetics: two years follow-up.

Read the detailed description

All the subjects in the study will receive non surgical periodontal treatment in one session (full-mouth scaling and root planing). Clinical parameters will be assessed in all teeth (except third molars) by one experienced and trained examiner before treatment and every 3 months for 2 years. Visible plaque index (VPI) will be represented a mean percentage of sites with visible plaque calculated for all teeth analyzed (four sites per tooth). Others parameters will be assessed at six sites per tooth using a manual periodontal probe (15mm). Bleeding on probing (BOP) will be represented the mean percentage of sites with bleeding (up to 15 seconds after probing) calculated for all teeth analyzed. Probing depth (PD - distance between the gingival margin and the bottom of the sulcus/pocket), gingival recession (GR - distance between the cementoenamel junction and gingival margin) and clinical attachment level (CAL - distance between the cementoenamel junction and the bottom of the sulcus/pocket) will be represented a mean distance calculated per site for all teeth analyzed. For blood parameters, an outside laboratory will perform all blood analysis. It will be requested for each subject with diabetes (DG) at baseline, each 3 months post-treatment. Fasting plasma glucose (FPG) will be expressed in milligrams per deciliter and HbA1c will be expressed as a percentage. Statistical analysis will be performed using an available software program and the patient will be considered as the unit of analysis.The data will be processed and analyzed by descriptive and inferential statistics, probably nonparametric.

Being tested
Full Mouth Scaling and Root Planing
Keywords
Dental Scaling, Blood Glucose, Hemoglobin A, Glycosylated
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.

  • Full Mouth Scaling and Root PlaningProcedure or surgery

    This procedure was performed as described by Quirynen et al. 2005 with some modifications

Study groups in NCT02643771
Study groupRoleWhat they receive
Diabetic groupExperimentalSubjects with Chronic Periodontitis and Type 2 Diabetes Mellitus treated with non surgical periodontal therapy (Full Mouth Scaling and Root Planing)
Receives: Procedure: Full Mouth Scaling and Root Planing
Nondiabetic groupExperimentalSubjects with Chronic Periodontitis and without Type 2 Diabetes Mellitus treated with non surgical periodontal therapy (Full Mouth Scaling and Root Planing)
Receives: Procedure: Full Mouth Scaling and Root Planing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of bleeding on probing

    The mean percentage of periodontal sites with bleeding on probing

    Measured: Baseline

  2. Percentage of bleeding on probing

    The mean percentage of periodontal sites with bleeding on probing

    Measured: at three months

  3. Percentage of bleeding on probing

    The mean percentage of periodontal sites with bleeding on probing

    Measured: at six months

  4. Percentage of bleeding on probing

    The mean percentage of periodontal sites with bleeding on probing

    Measured: at nine months

  5. Percentage of bleeding on probing

    The mean percentage of periodontal sites with bleeding on probing

    Measured: at twelve months

  6. Percentage of bleeding on probing

    The mean percentage of periodontal sites with bleeding on probing

    Measured: at eighteen months

  7. Percentage of bleeding on probing

    The mean percentage of periodontal sites with bleeding on probing

    Measured: at twenty four months

Secondary outcomes (3)

  1. Percentage of visible plaque index

    The mean percentage of periodontal sites with visible plaque

    Measured: Baseline and at three, six, nine, twelve, eighteen and twenty four months

  2. Probing depth (mm)

    The mean of probing depth in millimeters calculated for periodontal sites.

    Measured: Baseline and at three, six, nine, twelve, eighteen and twenty four months

  3. Clinical attachment level (mm)

    The mean of clinical attachment level in millimeters calculated for periodontal sites.

    Measured: Baseline and at three, six, nine, twelve, eighteen and twenty four months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2015 (estimated)
  2. Study startJan 2013
  3. Primary completionOct 2016 (estimated)
  4. Study completionOct 2017 (estimated)

Resources

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 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02643771
Sponsor's protocol ID
U1111-1175-5481
Status last verified
Dec 2015
First submitted
28 Dec 2015
Last updated
31 Dec 2015
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Quirynen M, Bollen CM, Vandekerckhove BN, Dekeyser C, Papaioannou W, Eyssen H. Full- vs. partial-mouth disinfection in the treatment of periodontal infections: short-term clinical and microbiological observations. J Dent Res. 1995 Aug;74(8):1459-67. doi: 10.1177/00220345950740080501.

    PubMed 7560400

  • Lopez NJ, Smith PC, Gutierrez J. Periodontal therapy may reduce the risk of preterm low birth weight in women with periodontal disease: a randomized controlled trial. J Periodontol. 2002 Aug;73(8):911-24. doi: 10.1902/jop.2002.73.8.911.

    PubMed 12211502

  • Almeida ML, Duarte PM, Figueira EA, Lemos JC, Nobre CMG, Miranda TS, de Vasconcelos Gurgel BC. Effects of a full-mouth disinfection protocol on the treatment of type-2 diabetic and non-diabetic subjects with mild-to-moderate periodontitis: one-year clinical outcomes. Clin Oral Investig. 2020 Jan;24(1):333-341. doi: 10.1007/s00784-019-02927-8. Epub 2019 May 17.

    PubMed 31102044

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Full Mouth Scaling and Root Planing in people with Chronic Periodontitis and Diabetes Mellitus, Type 2, run by Eduardo Aleixo Figueira at 1 site in Brazil.

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 6 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 31 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 Brazil. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Bruno CV Gurgel, Doctor (+558432154136, bcgurgel@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of bleeding on probing (time frame: Baseline). The study lists 7 primary outcomes in all. 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 NCT02643771, which also lists 3 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 31 Dec 2015.

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