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

NCT01848379 | Unknown DMC

• 1 other identifier: DMS017507GI
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Chronic Periodontitis; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (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.

  0, 6 and 12 months

Secondary Outcomes (4)

• Probing Pocket Depth (PPD)

  0, 6 and 12 months

• Bleeding on Probing (BOP)

  0, 6 and 12 months

• Body Mass Index (BMI)

  -3 weeks; 0, 6 and 12 months

• Glycated Hemoglobin (HbA1c)

  -3 weeks; 0, 6 and 12 months

Other Outcomes (8)

• Neutrophil Cytoplasmic Calcium Concentration ([Ca2+]i)

  -3, 0 and 2 weeks; 6 and 12 months

• Neutrophil Cytoplasmic pH (pHi)

  -3, 0 and 2 weeks; 6 and 12 months

• Release of Reactive Oxygen Species (ROS)

  -3, 0 and 2 weeks; 6 and 12 months

Study Arms (3)

Antidiabetic Therapy(ADT)+Full Mouth Decontamination(FD)

EXPERIMENTAL

ADT: (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)

Procedure: ADT+FD

Full Mouth Deconatamination(FD)

ACTIVE COMPARATOR

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)

Procedure: FD

No Treatment

NO INTERVENTION

Healthy individuals to be monitored cross-sectional

Interventions

ADT+FD PROCEDURE

Also known as: Anti-diabetic Treatment and Full Mouth Decontamination

Antidiabetic Therapy(ADT)+Full Mouth Decontamination(FD)

FD PROCEDURE

Also known as: Full Mouth Decontamination

Full Mouth Deconatamination(FD)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Zentrum fuer Zahn-, Mund- und Kieferheilkunde: lead

Study Sites (1)

Department of Periodontontology, ZentrumZMK

Giessen, 35392, Germany

Location

Related Publications (1)

• 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.

  PMID: 31912903 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jens Martin Herrmann, Dr.

  Department of Periodontology, ZentrumZMK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research associate

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 7, 2013
• Study Start: January 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

DE (1)