PeriodontitisPhase 4NCT02062047

Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects

A Phase 4 study testing FMSRP, Chlorhexidine and PMSRP in people with Periodontitis and Diabetes, run by University of Guarulhos.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 70 years
Conditions the study is for: Periodontitis, Diabetes
What is being tested?: FMSRP, Chlorhexidine and PMSRP
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: No sites listed yet
Study dates: Dec 2007to Apr 2010
Phase: Phase 4
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of type 2 diabetes mellitus
Clinical diagnosis of generalized chronic periodontitis
> 30 years old
At least 15 teeth excluding third molars and teeth indicated to exodontia
More than 30% of the sites with probing depth and clinical attachment level ≥ 4 mm at baseline

Who cannot join

Pregnancy
Lactation
Current smoking
Smoking within the past 5 years
Periodontal or/and antibiotic therapies in the previous 6 months
Regular use of mouthrinses containing antimicrobials in the preceding 2 months

Show all 11Show fewer

Other systemic condition that could affect the progression of periodontal disease
Long-term use of anti-inflammatory and immunosuppressive medications
Presence of periapical pathology
Use of orthodontic appliances
Multiple systemic complications of DM.

About this study

Official title: Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects: Clinical, Immunological and Microbiological Outcomes

The aim of this study will be to evaluate: 1- the effect of full-mouth (FM) scaling and root (SRP) planing in 24 hours associated with or without extensive application of chlorhexidine (CLX) on clinical, microbiological, glycemic and immunological parameters in diabetic subjects with chronic periodontitis at 3, 6 and 12 months post-therapy. The hypothesis is that FMSRP associated with CLX use will provide the best clinical, microbiological, glycemic and immunological outcomes for the treatment of diabetic subjects with periodontitis. Sixty diabetic subjects with chronic periodontitis will be divided in the following therapeutic groups (n=20 subjects per group): FMSRP+CLX group - FMSRP in a maximum of 24 hours, application and irrigation of chlorhexidine 2% gel, rinsing chlorhexidine 0.12% solution during 60 days; FMSRP + placebo group - FMSRP in a maximum of 24 hours, application and irrigation of placebo, rinsing placebo solution during 60 days; Partial-mouth (PM) SRP group: SRP in 4-6 sessions in a maximum of 2 weeks. The following clinical parameters will be evaluated at 3, 6 and 12 months post-therapy: plaque accumulation, gingival bleeding, probing depth, clinical attachment level, bleeding on probing and suppuration. At these same periods, glycated hemoglobin levels will be obtained from all subjects. In addition, six subgingival biofilm samples per subject will be analyzed by checkerboard DNA-DNA hybridization for 40 bacterial species at baseline, 3, 6 and 12 post-therapy. Finally, gingival crevicular fluid samples from two shallow and two deep sites will be evaluated for the levels of cyto/chemokines by ELISA. Data will be submitted to appropriate statistical analysis.

Conditions: Periodontitis, Diabetes
Being tested: FMSRP, Chlorhexidine, PMSRP, Placebo
Keywords: Diabetes Mellitus, Chronic Periodontitis, Root Planing, Cytokines, microbiology, Glycated hemoglobin, diabetic subjects
Medical subject headings: Periodontitis, Diabetes Mellitus, Chronic Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FMSRPProcedure or surgery
FMSRP in a maximum of 24 hours.
ChlorhexidineDrug
Also called (N/A)
Application and irrigation of chlorhexidine, rinsing chlorhexidine solution during 60 days
PMSRPProcedure or surgery
Scaling and root planing in 4-6 sessions in a maximum of 2 weeks
PlaceboOther
Application and irrigation of placebo, rinsing placebo solution during 60 days

Study groups in NCT02062047
Study group	Role	What they receive
FMSRP+CLX	Experimental	Full-mouth scaling and root planing in a maximum of 24 hours, application and irrigation of chlorhexidine 2% gel, rinsing chlorhexidine 0.12% solution during 60 days Receives: Procedure: FMSRP; Drug: Chlorhexidine
FMSRP + placebo group	Placebo comparator	Full-mouth scaling and root planing in a maximum of 24 hours, application and irrigation of placebo, rinsing placebo solution during 60 days Receives: Procedure: FMSRP; Other: Placebo
PMSRP group	Active comparator	Partial-mouth scaling and root planing in 4-6 sessions in a maximum of 2 weeks Receives: Procedure: PMSRP

What is being measured

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

Changes in clinical attachment level (CAL) in sites with initial PD ≥7mm from baseline to 12 months.
Measured: From baseline to 12 months

Secondary outcomes (15)

Changes in percentage of sites with probing depth ≥5mm
Measured: From baseline to 12 months
Changes in serum levels of glycemic hemoglobin
Measured: From baseline to 12 months
Changes in the counts of pathogenic bacterial species
Measured: From baseline to 12 months
Changes in the levels of tumor necrosis factor-α in gingival crevicular fluid
Measured: From baseline to 12 months
Changes in the levels of plaque accumulation
Measured: From baseline to 12 months
Changes in the mean percentage of sites with bleeding on probing
Measured: From baseline to 12 months
Changes in the full-mouth probing depth
Measured: From baseline to 12 months
Changes in the serum levels of fasting plasma glucose
Measured: From baseline to 12 months
Changes in the proportions of pathogenic bacterial species
Measured: From baseline to 12 months
Changes in the levels of interferon (IFN)-γ in gingival crevicular fluid
Measured: From baseline to 12 months
Changes in the levels of interleukin (IL)-17 in gingival crevicular fluid
Measured: From baseline to 12 months
Changes in the levels of IL-23 in gingival crevicular fluid
Measured: From baseline to 12 months
Changes in the levels of IL-4 in gingival crevicular fluid
Measured: From baseline to 12 months
Changes in levels of receptor activator of NF-κß ligand (RANKL) in gingival crevicular fluid
Measured: From baseline to 12 months
Changes in the levels of osteoprotegerin (OPG) in gingival crevicular fluid
Measured: From baseline to 12 months

Timeline

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

Dec 2007Apr 2010

First posted13 Feb 2014 (estimated)
Study startDec 2007
Primary completionMar 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02062047
Sponsor's protocol ID: SISNEP/277
Status last verified: Feb 2014
First submitted: 7 Feb 2014
Last updated: 13 Feb 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects: Clinical, Immunological and Microbiological Outcomes
ClinicalTrials.gov ID: NCT02062047
Acronym / sponsor ID: SISNEP/277
Conditions: Periodontitis, Diabetes
Keywords: Diabetes Mellitus, Chronic Periodontitis, Root Planing, Cytokines, microbiology, Glycated hemoglobin, diabetic subjects
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of GuarulhosUniversity, hospital or other
Study start: Dec 2007
Primary completion: Mar 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 13 Feb 2014 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
FMSRP+CLX	Experimental	Procedure: FMSRP, Drug: ChlorhexidineFull-mouth scaling and root planing in a maximum of 24 hours, application and irrigation of chlorhexidine 2% gel, rinsing chlorhexidine 0.12% solution during 60 days
FMSRP + placebo group	Placebo comparator	Procedure: FMSRP, Other: PlaceboFull-mouth scaling and root planing in a maximum of 24 hours, application and irrigation of placebo, rinsing placebo solution during 60 days
PMSRP group	Active comparator	Procedure: PMSRPPartial-mouth scaling and root planing in 4-6 sessions in a maximum of 2 weeks

Who may qualify

Ages: 30 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Clinical diagnosis of type 2 diabetes mellitus
Clinical diagnosis of generalized chronic periodontitis
> 30 years old
At least 15 teeth excluding third molars and teeth indicated to exodontia
More than 30% of the sites with probing depth and clinical attachment level ≥ 4 mm at baseline

Key exclusion criteria (11 listed)

Pregnancy
Lactation
Current smoking
Smoking within the past 5 years
Periodontal or/and antibiotic therapies in the previous 6 months

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
FMSRPFMSRP in a maximum of 24 hours.	Procedure or surgery	FMSRP + placebo group, FMSRP+CLX
ChlorhexidineAlso: (N/A)Application and irrigation of chlorhexidine, rinsing chlorhexidine solution during 60 days	Drug	FMSRP+CLX
PMSRPScaling and root planing in 4-6 sessions in a maximum of 2 weeks	Procedure or surgery	PMSRP group
PlaceboApplication and irrigation of placebo, rinsing placebo solution during 60 days	Other	FMSRP + placebo group

Primary outcome

Changes in clinical attachment level (CAL) in sites with initial PD ≥7mm from baseline to 12 months.
Time frame: From baseline to 12 months

15 secondary outcomes

Changes in percentage of sites with probing depth ≥5mm
Time frame: From baseline to 12 months
Changes in serum levels of glycemic hemoglobin
Time frame: From baseline to 12 months
Changes in the counts of pathogenic bacterial species
Time frame: From baseline to 12 months
Changes in the levels of tumor necrosis factor-α in gingival crevicular fluid
Time frame: From baseline to 12 months
Changes in the levels of plaque accumulation
Time frame: From baseline to 12 months
Changes in the mean percentage of sites with bleeding on probing
Time frame: From baseline to 12 months
Changes in the full-mouth probing depth
Time frame: From baseline to 12 months
Changes in the serum levels of fasting plasma glucose
Time frame: From baseline to 12 months
Changes in the proportions of pathogenic bacterial species
Time frame: From baseline to 12 months
Changes in the levels of interferon (IFN)-γ in gingival crevicular fluid
Time frame: From baseline to 12 months
Changes in the levels of interleukin (IL)-17 in gingival crevicular fluid
Time frame: From baseline to 12 months
Changes in the levels of IL-23 in gingival crevicular fluid
Time frame: From baseline to 12 months
Changes in the levels of IL-4 in gingival crevicular fluid
Time frame: From baseline to 12 months
Changes in levels of receptor activator of NF-κß ligand (RANKL) in gingival crevicular fluid
Time frame: From baseline to 12 months
Changes in the levels of osteoprotegerin (OPG) in gingival crevicular fluid
Time frame: From baseline to 12 months

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 13 Feb 2014.

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Active, not recruitingObservational study
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Recruiting
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Recruiting
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Recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FMSRP, Chlorhexidine and PMSRP in people with Periodontitis and Diabetes, run by University of Guarulhos.

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 5 inclusion and 11 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 13 Feb 2014. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

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?

Changes in clinical attachment level (CAL) in sites with initial PD ≥7mm from baseline to 12 months. (time frame: From baseline to 12 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 NCT02062047.

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 13 Feb 2014.