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Long-term Results After Systematic Periodontal Therapy (SYSPERIO10)

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ClinicalTrials.gov Identifier: NCT03048045
Recruitment Status : Enrolling by invitation
First Posted : February 9, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Eickholz, Goethe University

Brief Summary:
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.

Condition or disease Intervention/treatment
Tooth Loss Procedure: Supportive Periodontal Treatment (SPT)

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-term Results After Systematic Periodontal Therapy
Study Start Date : June 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Group/Cohort Intervention/treatment
Supportive Periodontal Treatment (SPT)
  • at least 18 years old.
  • periodontal treatment (antiinfective therapy with subgingival debridement under local anesthesia and if required periodontal surgery) at the Dept. of Periodontology starting after April 2005 durchgeführt.
  • complete periodontal charting (PPD and PAL-V at 6 sites per tooth, furcation involvement [Hamp et al. 1975] at all furcation sites of multi-rooted teeth) prior to treatment (baseline, T0) and after completion of active periodontal treatment (APT) (reevaluation 1 or 2/start of supportive periodontal therapy, T1)
  • radiographs of all teeth (periapical radiographs or panoramic radiograph) from baseline
  • written informed consent
Procedure: Supportive Periodontal Treatment (SPT)
Assessment of Gingival Bleeding Index and Plaque Control Record, re-instruction and re-motivation to effective individual plaque control, professional tooth cleaning, application of a fluoride gel. Twice a year a periodontal charting with probing pocket depths (PPD) and vertical attachment Level (PAL-V) are obtained at 6 sites per tooth. Thirty seconds after probing bleeding on probing (BOP) is recorded. Sites exhibiting PPD = 4 mm and BOP as well as sites with PPD >/= 5 mm are scaled subgingivally. Assignment of SPT intervals is performed according to the periodontal risk assessment (PRA).




Primary Outcome Measures :
  1. tooth loss during supportive periodontal treatment [ Time Frame: 10 years ]
    tooth loss during supportive periodontal treatment


Secondary Outcome Measures :
  1. clinical attachment loss during supportive periodontal treatment [ Time Frame: 10 years ]
    clinical attachment loss during supportive periodontal treatment


Other Outcome Measures:
  1. Change of PISA during supportive periodontal treatment [ Time Frame: 10 years ]
    Change of PISA during supportive periodontal treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion criteria:

  • at least 18 years old
  • 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
  • complete periodontal charts (probing pocket depths [PPD] and vertical probing attachment level [PAL-V] at 6 sites per tooth, furcation involvement at all furcation sites of multi-rooted teeth) Prior to periodontal treatment (baseline, T0) and after accomplishment of active periodontal Treatment (APT) (reevaluation 1 or 2 and start of SPT, T1)
  • radiographs of all teeth (periapical or panoramic) at baseline
  • written informed consent

Exclusion citeria:

  • younger than 18 years
  • no 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
  • missing complete periodontal charts (probing pocket depths [PPD] and vertical probing attachment level [PAL-V] at 6 sites per tooth, furcation involvement at all furcation sites of multi-rooted teeth) Prior to periodontal treatment (baseline, T0) and after accomplishment of active periodontal Treatment (APT) (reevaluation 1 or 2 and start of SPT, T1)
  • no radiographs of all teeth (periapical or panoramic) at baseline
  • missing written informed consent.

Individual dropout criteria:

- retraction of consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048045


Locations
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Germany
Dept. of Periodontology, Center of Dentistry and Oral Medicine, Johann Wolfgang Goethe-University
Frankfurt am Main, Germany, 60590
Sponsors and Collaborators
Goethe University
Investigators
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Study Director: Peter Eickholz, Prof. Dr. Goethe University

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Responsible Party: Peter Eickholz, Prof. Dr. Peter Eickholz, Goethe University
ClinicalTrials.gov Identifier: NCT03048045     History of Changes
Other Study ID Numbers: 61/15
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Peter Eickholz, Goethe University:
chronic periodontitis
aggressive periodontitis
supportive periodontal treatment

Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases