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Patients who had had systematic periodontal treatment (antiinfective treatment with subgingival debridement under local anaesthesia and if required periodontal surgery) at the Dept. of Periodontology starting from October 2004 are re-examined 10 years +/- 12 months after accomplishment of active periodontal therapy (re-evaluation 1 or 2, start of supportive periodontal treatment) until 100 patients have been enroled. Radiographs (periapicals or panoramics) from start of treatment should be available.
Full description
5.1 Patients
Patients who had had systematic periodontal treatment (antiinfective treatment with subgingival debridement under local anaesthesia and if required periodontal surgery) at the Dept. of Periodontology starting from October 2004 are re-examined 10 years +/- 12 months after accomplishment of active periodontal therapy (re-evaluation 1 or 2, start of supportive periodontal treatment) until 100 patients have been enroled. Radiographs (periapicals or panoramics) from start of treatment should be available.
Inclusion criteria:
Exclusion citeria:
Individual dropout criteria:
retraction of consent
5.2 Recruitment and clinical examination
All patients who had had systematic periodontal treatment (antiinfective treatment with subgingival debridement under local anaesthesia according to the full mouth disinfection protocol and if required periodontal surgery) at the Dept. of Periodontology starting from October 2004 and of whom radiographs (periapicals or panoramics) from start of treatment are available are invited for re-examination 10 years +/- 12 months after accomplishment of active periodontal therapy (re-evaluation 1 or 2, start of supportive periodontal treatment) until 100 patients have been enroled. For patients not agreeing to the invitation the respective reasons are documented (e.g. could not be contacted due to unknown new address). The follow-up is performed by the participating examiners and encompasses the following examinations:
In each patient PPD and PAL-V measurements are repeated in one sextant to assess the reproducibility of measurements.
5.3 Radiographic evaluation
Prior to subgingival debridement/periodontal surgery periapical radiographs (Insight; Kodac, Rochester, NY, USA) using film holders (XCP, Kentzler & Kaschner Dental, Ellwangen/Jagst) or panoramic radiographs had been obtained. Radiographs were obtained using the appropriate dose (Heliodent 70*, 70 kV, 7 mA, Sirona, Bensheim) and were developed (XR24 nova*, Dürr Dental, Bietigheim-Bissingen).
All radiographs are viewed in a darkened room using a radiograph screen. Relative percentage of bone loss is assessed at the most periodontally affected site of each tooth using a Schei ruler. Teeth were assigned i) to one of 5 groups of periodontal bone loss (< 20%, 20/< 40%, 40/< 60%, 60/< 80%, 80% and more) and ii) in conjunction with furcation involvement to one of 3 groups for the assessment of tooth-related prognosis (< 50%, 50-75%, > 75%). Furthermore, at the interproximal site with the most severe bone loss of each tooth, the type of bone loss is characterized as horizontal or vertical (infrabony defect). At each infrabony defect the depth of the infrabony component is measured to the next 0.1 mm using a loupe with 10fold magnification (Scale loupe 10x, Peak, Tohkai Sangyo, Tokyo, Japan). Each infrabony defect is allocated to one of 3 groups: shallow (2 mm), moderate (2.5-4 mm), and deep (>/= 4.5 mm) defects. For each tooth it is assessed whether a double contour of the root could be detected. A double contour is interpreted as indicator for a mesial or distal root groove.
All radiographic assessments are performed by an independent examiner blinded for clinical measurements and therapy rendered.
5.4 Evaluation of patient charts
Each patient is assigned to a periodontal diagnosis (e.g. generalised moderate chronic periodontitis) according to the actual classification of periodontal diseases.
According to baseline data each tooth is assigned to a prognosis category:
For each patient a prognosis index is calculated (number of hopeless and questionable teeth divided by the whole number of teeth).
The periodontal status at re-examination will be scored according to the most recent criteria of the Swiss Dental Society using precise threshold according to the 2005 criteria.
5.5 Statistical analysis
The patient is defined as statistical unit. Main outcome variable is tooth loss from the end of APT (T1) to re-examination (T2). Secondary endpoints are: PAL-V loss, PISA (periodtally inflamed surface area) change from T1 to T2, SSO criteria at T0, T1, T2 as well as average PPD, PISA, PPD categories at T0, T1, T2.
Using Poisson regression analysis patient-related factors (sex, age, socieconimic status, baseline diagnosis [chronic or aggressive periodontitis], IL-1 polymorphism, mean bone loss in %, cigarette consumption, regular SPT participation ) and using logistic multilevel regression analysis tooth-related (PPD at T1 [deepest pocket/tooth], PAL-V at T1, bone loss in % [T0], furcation involvement [most severe furcation ionvolvement/tooth], tooth type [single-rooted, multi-rooted with/without furcation involvement], type of bone loss [horizontal/vertical, shallow, moderate, deep infrabony defects], baseline prognosis) factors shall be indentified that explain tooth loss during SPT or quality standards.
Enrollment
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Inclusion and exclusion criteria
Inclusion criteria:
Exclusion citeria:
Individual dropout criteria:
100 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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