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Chronic PeriodontitisDMSNCT01848379

White Blood Cell Signaling and Defense Mechanisms in Patients With Diabetes Mellitus Type 2 and Periodontitis

A study testing ADT+FD and FD in people with Chronic Periodontitis and Diabetes Mellitus, Type 2, run by Zentrum fuer Zahn-, Mund- und Kieferheilkunde at 1 site in Germany.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

White blood cell membrane and surface structures are affected by the metabolic disorders and complications found in diabetes mellitus. Therefore, cellular activation, signal propagation, intracellular signaling as well as bactericidal effector functions are altered. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
ADT+FD and FD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteGermany
Study dates
Jan 2012to Dec 2017
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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Diabetes Mellitus, Type II
  • Glycated Hemoglobin ≥8.5%
  • Chronic Periodontitis
  • Patients and controls should have at least 12 natural teeth (without subgingival fillings, crowns or caries)

Who cannot join

  • Pregnancy
  • Smoking
  • Low Body Mass Index (BMI <18.5kg/m*m)
  • Severe cardiovascular disease including coronary artery disease, cerebral vascular disease, peripheral vascular disease, valvular heart disease, and congestive heart failure
  • Other major illnesses including cancer, liver disease, pulmonary disease, chronic infectious disease other than periodontitis (HIV, hepatitis, etc.), rheumatological disease, hematological disease, or any condition requiring hospitalization or chronic medical therapy other than diabetes.
  • Major psychiatric illness requiring treatment, or that might interfere with the ability to understand or cooperate with the protocol
Show all 13Show fewer
  • Ongoing alcohol or drug abuse; all forms of medication or illegal substance abuse
  • Systemic enteral or parenteral medication, in part daily vitamin or anti-oxidative supplementation and certain calcium channel blockers (i.e. Nifedipine); but anti diabetic drugs or insulin substitution
  • Allergies to antibiotics or adjuvant medication / antiseptics as well as dental materials in use (including gloves) in particular those against topical antiseptic solutions i.e. chlorhexidine / N',N'''''-hexane-1,6-diylbis[N-(4-chlorophenyl)(imidodicarbonimidic diamide)] or povidone iodine / 2-Pyrrolidinone, 1-ethenyl-, homopolymer, compound with iodine
  • Severe dental disease defined as severe dental caries, and/or severe pulpal disease requiring surgical correction, or any other mucosal or dental condition not readily treated, or requiring extensive dental, oral surgical or prosthetic treatment, or any other oral treatment which could affect the outcome of periodontal therapy or diseases or syndromes that require systemic medication.
  • Systemic, topical or inhaled steroid treatment for more than 30 consecutive days within 6 weeks of baseline.
  • Any periodontal treatment within 6 months prior to baseline
  • For controls: a periodontal screening index (PSI) > 1

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Periodontontology, ZentrumZMK

    Giessen, 35392

Other trials in Germany

About this study

Official title: Human Polymorphonuclear Neutrophil (PMN) Cytosolic Signaling and Effector Functions in Patients With Diabetes Mellitus Type 2 and Periodontitis

White blood cell membrane and surface structures are affected by the metabolic disorders and complications found in diabetes mellitus. Therefore, cellular activation, signal propagation, intracellular signaling as well as bactericidal effector functions are altered.

When diabetic symptoms are corrected by the systemic intervention and treatment of the patients (Anti-diabetic Therapy/ADT, i.e. anti-diabetic medication, diet and dietetic supervision, physiotherapy and physical exercises), white blood cell functions will then normalize and reach the functionality comparable to those cells derived from healthy subjects.

Read more

Gum diseases like periodontitis have long been associated with and termed complications of uncontrolled diabetes mellitus. Vice versa, after diabetic conditions are corrected, periodontitis treatment will be proven effective, when oral hygiene regimen, full mouth decontamination (FD, i.e. the oral use of topical antiseptics prior and after professional mechanical tooth cleaning, tooth as well as root surface planing, polishing as well as gum and soft tissue decontamination in combination with systemic antibiotics) are performed. To reinforce gum healing, reinfection prevention (RP) as well as supportive periodontal therapy (SPT) will be administered by dental professionals on an individual basis and a detailed schedule.

If periodontal pockets critical for participant's self care are not eliminated by FD including RP and SPT, and niches >5mm after 6 month persist, patients are informed and offered surgical intervention as indicated for gum disease elimination.

Dental follow up exams will be offered to all participants.

Read the detailed description

Specific Aims

  1. To investigate if cytosolic Ca2+- ( delta[Ca2+]i) and pH (delta_pHi) signaling responses and bactericidal effector functions of PMN dependent upon the status of diabetic control and are reduced or increased when compared to age and gender matched controls
  2. To determine the biochemical basis for diabetic PMN alteration of motility as well as bactericidal functions: production of superoxide and release of elastase, respectively
  3. To characterize the molecular basis of the observed alterations in the regulation of cytosolic calcium (delta[Ca2+]i) and pH (delta_pHi) exhibited by diabetic PMN
  4. To investigate if the pre-activated state and altered bactericidal functionality of diabetic PMN are reversed when the patients' glycemic control is normalized, blood glucose levels as well as periodontal disease are corrected
  5. To evaluate, if systemic and periodontal intervention can lead to clinical attachment gain in patients with diabetes mellitus type 2
Being tested
ADT+FD, FD
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.

  • ADT+FDProcedure or surgery

    Also called Anti-diabetic Treatment and Full Mouth Decontamination

  • FDProcedure or surgery

    Also called Full Mouth Decontamination

Study groups in NCT01848379
Study groupRoleWhat they receive
Antidiabetic Therapy(ADT)+Full Mouth Decontamination(FD)ExperimentalADT: (Par-)enteral, anti-diabetic medication, diet and dietetic supervision, physiotherapy and physical exercises FD: The oral use of topical antiseptics prior and after mechanical tooth debridement, tooth as well as root surface planing and soft tissue decontamination in combination with systemic antibiotics (a combination of amoxicillin and metronidazole - if no microbial resistances were detected)
Receives: Procedure: ADT+FD
Full Mouth Deconatamination(FD)Active comparatorFD: The oral use of topical antiseptics prior and after mechanical tooth debridement, tooth as well as root surface planing and soft tissue decontamination in combination with systemic antibiotics (a combination of amoxicillin and metronidazole - if no microbial resistances were detected)
Receives: Procedure: FD
No TreatmentNo interventionHealthy individuals to be monitored cross-sectional

What is being measured

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

  1. Change from Baseline in Clinical Attachment Level (CAL) at 6 and 12 Months

    CAL: Clinically and quantitatively, level of attachment is defined as the distance in mm from the cemento-enamel junction (CEJ) of the teeth to the bases of the periodontal pockets. Attachment gain may be found during healing or periodontal treatment procedures.

    Measured: 0, 6 and 12 months

Secondary outcomes (4)

  1. Probing Pocket Depth (PPD)

    PPD: also called periodontal probing depth is defined as the distance in millimeters from the gingival margin to the base of the sulcus or periodontal pocket. It is measured on six surfaces/tooth (disto-buccal, mid-buccal, mesio-buccal, disto-lingual, mid-lingual, and mesio-lingual) of all teeth present using the pressure calibrated Florida probe.

    Measured: 0, 6 and 12 months

  2. Bleeding on Probing (BOP)

    BOP: will be determined by recording the presence or absence of bleeding following probing to determine pocket depth (PPD). This parameter will be expressed as % bleeding sites out of all examined sites in the dentition and will be documented with the Florida probe software.

    Measured: 0, 6 and 12 months

  3. Body Mass Index (BMI)

    The body mass index will be assessed as the participants' body mass divided by the square of their height

    Measured: -3 weeks; 0, 6 and 12 months

  4. Glycated Hemoglobin (HbA1c)

    Physiological levels of blood glucose result in a normal amount of glycated hemoglobin. Treatment procedures may help to reduce plasma glucose in individuals with diabetes mellitus type 2, thus, in a timely extended fashion the fraction of glycated hemoglobin.

    Measured: -3 weeks; 0, 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.

  1. First posted7 May 2013 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 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 N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01848379
Sponsor's protocol ID
DMS017507GI
Acronym
DMS
Status last verified
Jun 2017
First submitted
29 Apr 2013
Last updated
2 Jul 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Herrmann JM, Sonnenschein SK, Groeger SE, Ewald N, Arneth B, Meyle J. Refractory neutrophil activation in type 2 diabetics with chronic periodontitis. J Periodontal Res. 2020 Apr;55(2):315-323. doi: 10.1111/jre.12717. Epub 2020 Jan 8.

    PubMed 31912903

Questions about this trial

What is this clinical trial studying?

A study testing ADT+FD and FD in people with Chronic Periodontitis and Diabetes Mellitus, Type 2, run by Zentrum fuer Zahn-, Mund- und Kieferheilkunde at 1 site in Germany.

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 4 inclusion and 13 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 2 Jul 2017. 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 Germany. 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?

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 Clinical Attachment Level (CAL) at 6 and 12 Months (time frame: 0, 6 and 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 NCT01848379, which also lists 1 linked publication.

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 2 Jul 2017.

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