Tooth LossSYSPERIO10NCT03048045
Long-term Results After Systematic Periodontal Therapy
An observational study of Tooth Loss, run by Goethe University at 1 site in Germany.
Trial summary
Patients who had had systematic periodontal treatment (antiinfective treatment with subgingival debridement under local anaesthesia and if required periodontal surgery) at the Dept. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Supportive Periodontal Treatment (SPT)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Periodontology, Center of Dentistry and Oral Medicine, Johann Wolfgang Goethe-University
Frankfurt am Main, 60590
About this study
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.
Read the detailed description
- Material and Methods
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:
- 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:
- Patients that do not meet the inclusion criteria.
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:
- measurement of CO in exhaled air as measure for cigarette smoking (Bedfont EC50-Micro; Bedfont Scientific Ltd, Rochester, Great Britain). Patients are asked for cigarette smoking: Do you actually smoke and if yes, how many cigarettes per day? Did you smoke in earlier times? If yes how long (years) and how many cigarettes per day? After the questionnaire the CO measurement is repeated.
- Using patients' charts it is documented for each patient whether he or she had attended SPT at the Dept. of Periodontology of the Goethe-University Frankfurt regularly complying with the intervals that had been recommended. If a patient had extended the recommended SPT interval at least once more than 100% he or she is assigned to the irregular SPT group (e.g. the recommended SPT interval is 6 months and the patient returns for SPT after 13 months). Further, rhythm and number of SPT visits is scored.
- General medical history and extended helath questionnaire
- Dental status, sensitivity testing
- Modified GBI
- Modified PCR
- Measurement of probing pocket depths (PPD) and vertical attachment levels (PAL-V) to the nearest 1 mm using a manual periodontal probe (PCPUNC 15; Hu Friedy, Chicago, IL, USA) at 6 sites per tooth, bleeding on probing after 30 s (BOP), and suppuration on probing (SUP). Implantats are measured like teeth but marked as implants.
- At multirooted teeth assessment of furcation involvement using a Nabers probe that was marked in 3 mm increments (PQ2N; Hu Friedy, Chicago, IL, USA)
- Test for interleukin-1 (IL-1) polymorphism (IL-1A -889, IL-1B +3953) (GenoType IL-1-Test, Hain Life Science GmbH, Nehren, Germany), if IL-1 polymorphism had not been tested during routine SPT to estimate the individual periodontal risk and SPT interval. A patient is classified as IL-1 positive if both the second allele for IL-1A and IL-1B are positive.
- All patients who have lost teeth are asked for the reasons (e.g. caries, endodontic, periodontal, orthodontic, prosthetic, trauma etc.).
- All patients were asked about satisfaction with the aesthetic aspects of their periodontal situation (OHIP).
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:
- hopeless: bone loss > 75% or the tooth fulfils at least 2 criteria of category "questionable";
- questionable: bone loss between 50 and 75% or infrabony pocket (infrabony component > 2 mm) or furcation involvement;
- good: bone loss < 50% and nonne of the criteria for "qustionable" or "hopeless" are present.
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.
- Conditions
- Tooth Loss
- Being tested
- Supportive Periodontal Treatment (SPT)
- Keywords
- chronic periodontitis, aggressive periodontitis, supportive periodontal treatment
- Medical subject headings
- Tooth Loss, Chronic Periodontitis, Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive Periodontal Treatment (SPT)Procedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Supportive Periodontal Treatment (SPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
tooth loss during supportive periodontal treatment
tooth loss during supportive periodontal treatment
Measured: 10 years
Secondary outcomes (1)
clinical attachment loss during supportive periodontal treatment
clinical attachment loss during supportive periodontal treatment
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startJun 2015
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Eickholz, Goethe University
- Investigators
- Peter Eickholz, Prof. Dr., Study director, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048045
- Sponsor's protocol ID
- 61/15
- Acronym
- SYSPERIO10
- Status last verified
- Apr 2022
- First submitted
- 7 Feb 2017
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33748997Petsos 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.
PubMed 33145760Graetz 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.
PubMed 32112911Schroder 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.
PubMed 40629762Vogt 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.
PubMed 36723714
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Results After Systematic Periodontal Therapy
- ClinicalTrials.gov ID
- NCT03048045
- Acronym / sponsor ID
- SYSPERIO10 / 61/15
- Conditions
- Tooth Loss
- Keywords
- chronic periodontitis, aggressive periodontitis, supportive periodontal treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Material and Methods
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:
- 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:
- Patients that do not meet the inclusion criteria.
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:
- measurement of CO in exhaled air as measure for cigarette smoking (Bedfont EC50-Micro; Bedfont Scientific Ltd, Rochester, Great Britain). Patients are asked for cigarette smoking: Do you actually smoke and if yes, how many cigarettes per day? Did you smoke in earlier times? If yes how long (years) and how many cigarettes per day? After the questionnaire the CO measurement is repeated.
- Using patients' charts it is documented for each patient whether he or she had attended SPT at the Dept. of Periodontology of the Goethe-University Frankfurt regularly complying with the intervals that had been recommended. If a patient had extended the recommended SPT interval at least once more than 100% he or she is assigned to the irregular SPT group (e.g. the recommended SPT interval is 6 months and the patient returns for SPT after 13 months). Further, rhythm and number of SPT visits is scored.
- General medical history and extended helath questionnaire
- Dental status, sensitivity testing
- Modified GBI
- Modified PCR
- Measurement of probing pocket depths (PPD) and vertical attachment levels (PAL-V) to the nearest 1 mm using a manual periodontal probe (PCPUNC 15; Hu Friedy, Chicago, IL, USA) at 6 sites per tooth, bleeding on probing after 30 s (BOP), and suppuration on probing (SUP). Implantats are measured like teeth but marked as implants.
- At multirooted teeth assessment of furcation involvement using a Nabers probe that was marked in 3 mm increments (PQ2N; Hu Friedy, Chicago, IL, USA)
- Test for interleukin-1 (IL-1) polymorphism (IL-1A -889, IL-1B +3953) (GenoType IL-1-Test, Hain Life Science GmbH, Nehren, Germany), if IL-1 polymorphism had not been tested during routine SPT to estimate the individual periodontal risk and SPT interval. A patient is classified as IL-1 positive if both the second allele for IL-1A and IL-1B are positive.
- All patients who have lost teeth are asked for the reasons (e.g. caries, endodontic, periodontal, orthodontic, prosthetic, trauma etc.).
- All patients were asked about satisfaction with the aesthetic aspects of their periodontal situation (OHIP).
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:
- hopeless: bone loss > 75% or the tooth fulfils at least 2 criteria of category "questionable";
- questionable: bone loss between 50 and 75% or infrabony pocket (infrabony component > 2 mm) or furcation involvement;
- good: bone loss < 50% and nonne of the criteria for "qustionable" or "hopeless" are present.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Periodontal Treatment (SPT) | – | Procedure: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | Supportive Periodontal Treatment (SPT) |
Primary outcome
tooth loss during supportive periodontal treatment
Time frame: 10 years
tooth loss during supportive periodontal treatment
1 secondary outcome
clinical attachment loss during supportive periodontal treatment
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Results publication: PubMed 33748997Petsos 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.
- Results publication: PubMed 33145760Petsos 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.
- Results publication: PubMed 32112911Graetz 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.
- Derived from this study: PubMed 40629762Schroder 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.
- Derived from this study: PubMed 36723714Vogt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Eickholz, Prof. Dr. study director
Goethe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Loss, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tooth loss during supportive periodontal treatment (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03048045, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.