NCT03048045

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

9.5 years

First QC Date

February 7, 2017

Last Update Submit

April 4, 2022

Conditions

Keywords

chronic periodontitisaggressive periodontitissupportive periodontal treatment

Outcome Measures

Primary Outcomes (1)

  • tooth loss during supportive periodontal treatment

    tooth loss during supportive periodontal treatment

    10 years

Secondary Outcomes (1)

  • clinical attachment loss during supportive periodontal treatment

    10 years

Other Outcomes (1)

  • Change of PISA during supportive periodontal treatment

    10 years

Study Arms (1)

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)

Interventions

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).

Supportive Periodontal Treatment (SPT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Periodontology, Center of Dentistry and Oral Medicine, Johann Wolfgang Goethe-University

Frankfurt am Main, 60590, Germany

Location

Related Publications (5)

  • Petsos H, Ramich T, Nickles K, Dannewitz B, Pfeifer L, Zuhr O, Eickholz P. Tooth loss in periodontally compromised patients: Retrospective long-term results 10 years after active periodontal therapy - tooth-related outcomes. J Periodontol. 2021 Dec;92(12):1761-1775. doi: 10.1002/JPER.21-0056. Epub 2021 May 6.

  • Petsos H, Schacher B, Ramich T, Nickles K, Dannewitz B, Arendt S, Seidel K, Eickholz P. Retrospectively analysed tooth loss in periodontally compromised patients: Long-term results 10 years after active periodontal therapy-Patient-related outcomes. J Periodontal Res. 2020 Dec;55(6):946-958. doi: 10.1111/jre.12786. Epub 2020 Jul 22.

  • Graetz C, Baumer A, Eickholz P, Kocher T, Petsos H, Pretzl B, Schwendicke F, Holtfreter B. Long-term tooth retention in periodontitis patients in four German university centres. J Dent. 2020 Mar;94:103307. doi: 10.1016/j.jdent.2020.103307. Epub 2020 Feb 26.

  • Schroder M, Buchinger M, Dahmer I, Eickholz P, Petsos H. Clinical Treatment Endpoints After Active Periodontal Treatment and 10 Years of Supportive Periodontal Care: A Retrospective Cohort Study. J Clin Periodontol. 2025 Oct;52(10):1386-1397. doi: 10.1111/jcpe.14179. Epub 2025 Jul 8.

  • Vogt L, Pretzl B, Eickholz P, Ramich T, Nickles K, Petsos H. Oral health-related quality of life and patient-reported outcome measures after 10 years of supportive periodontal care. Clin Oral Investig. 2023 Jun;27(6):2851-2864. doi: 10.1007/s00784-023-04876-9. Epub 2023 Feb 1.

MeSH Terms

Conditions

Tooth LossChronic PeriodontitisAggressive Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth DiseasesPeriodontitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Eickholz, Prof. Dr.

    Goethe University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Peter Eickholz

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 9, 2017

Study Start

June 1, 2015

Primary Completion

December 1, 2024

Study Completion

March 1, 2025

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations