Patients will be excluded if they have clinical features known to influence the natural history of periodontal disease or are unable to comply with the study. The exclusion criteria are:
Low body mass index (BMI <18.5 kg/m2
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
In addition, dental diseases requiring treatment or concurrent medication may confound the ability to test the hypothesis that treatment of diabetes and/or periodontal disease prevents “pre-activation” of polymorphonuclear leukocytes
. Therefore, these patients will be excluded
Severe dental diseases defined as profound 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: PSI >1
Allergies (cf. above)
Dental and Periodontal Examinations (PAR1-4)
If a participating individual meets all inclusion criteria, he/she will undergo a baseline dental examination (PAR1) to categorize the presence and extent of periodontal disease. The examination will also include new radiographs (panoramic), unless recent films (within 6 months) are available. The oral examination will be performed by the study periodontist employing a Florida probe. At this time the examiner will include a detailed survey of face, lymph nodes, lips buccal mucosa, floor of the mouth, tongue, hard and soft palates, gingiva
, edentulous ridges, and teeth. Then the following features will be quantified employing an electro-mechanical probe.
Clinical attachment level:
Clinically and quantitatively, loss of attachment is defined as the distance in mm from the cemento-enamel junction (CEJ) to the base of the pocket. The measurement recorded is the distance from the CEJ to the gingival margin (GM), resulting in a positive or negative value depending on whether the GM is coronal (+) or apical (-) to the CEJ. Clinical attachment level is calculated according to the formula: (CAL=pocket depth–[GM–CEJ]) [33
]. For assessment of errors associated with measurement of pocket depth and clinical attachment level, trained and calibrated examiners will follow the protocol established by Grossi et al. [34
Probing depth also called Periodontal Probing Depth (PPD) is defined as the distance in millimeters from the gingival margin to the base of the sulcus or periodontal pocket. It is measured at six sites per tooth (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all teeth present.
All clinical examination will be performed by one trained dental examiner using the pressure calibrated Florida probe, but the two oral hygiene indices (cf. PBI and PLI).
Bleeding on probing:
Bleeding on probing will be determined by recording the presence or absence of bleeding
following probing to determine pocket depth. 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.
Modified papillary bleeding index:
PBI will be determined on each inter-proximal papilla except those mesial of the medial incisors by a modified procedure based on the studies Saxer et al, [35
]. A score of 0 to 4 will be given instantaneously after papilla probing with 0: no bleeding; 1: light, spotted bleeding; 2: moderate bleeding, several spots or a distinct line; 3: bleeding likely to fill the inter-proximal space and 4: almost spontaneous profound bleeding.
Modified dental plaque index:
Plaque will be assessed on 4 surfaces per tooth: lingual, buccal, inter-proximal (mesial and distal) [33
Decayed and missing teeth:
Decayed and missing teeth will also be recorded. The enrolled individuals will have the following clinical periodontal inclusion criteria consistent with the 1999 American Academy of Periodontology
classification of chronic generalized, severe periodontitis [37
]: Presence of at least 12 natural teeth and involvement of at least 6 teeth with pocket depth ≥ 6 mm and loss of attachment ≥ 5 mm in three aspects of each involved tooth. These criteria will be applied after accounting for necessary tooth extraction. Patients who require urgent dental procedures will not be considered eligible.