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PeriodontitisPhase 4ABPARO-StudieNCT00707369

Adjunctive Antimicrobial Therapy of Periodontitis: Long-Term Effects on Disease Progression and Oral Microbiological Colonization

A Phase 4 study testing Amoxicillin and Metronidazole in people with Periodontitis, run by University Hospital Muenster at 8 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the size of the benefit of an adjunctive empiric antibiotic therapy compared to standard mechanical debridement and oral hygiene instructions in a representative sample of German periodontitis patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Periodontitis
What is being tested?
Amoxicillin and Metronidazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
540 participants
Where
8 sitesGermany
Study dates
Oct 2008to Jan 2012
Phase
Phase 4
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • periodontal screening index (PSI) of IV in at least one sextant;
  • range from 18 to 75 years of age;
  • clinical and radiographic signs of moderate (clinical attachment loss [CAL] of 3 to 4 mm) to severe (CAL 5 mm or more) chronic or aggressive periodontitis;
  • at least 10 natural teeth in situ;
  • pocket probing depths (PPDs) of ≥ 6 mm at a minimum of four teeth;
  • willingness to participate and to be available at all times required for participation;
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  • willingness to abstain from using antimicrobial mouth-rinses during the study except for those explicitly prescribed;
  • informed consent signed by the patient;
  • sufficient knowledge of German language.

Who cannot join

  • if they (or parents or siblings) show confirmed or assumed allergies or hyper-sensitive skin reactions against amoxicillin (or other penicillins or other ingredients of Amoxicillin-ratiopharm® 500mg as listed in the "summary of product characteristics, Version Juli 2005"), metronidazole (or other 5-nitroimidazoles and ingredients of Flagyl® 400mg as listed in the "summary of product characteristics, Version Juli 2007"), systemic diseases or conditions as listed in the above mentioned "summary of product characteristics", or show confirmed lactose intolerance;
  • have Down's syndrome;
  • known AIDS/HIV;
  • regularly take systemic medication affecting the periodontal conditions, e.g. phenytoin, nifedipine, and/or steroid drugs;
  • professional periodontal therapy during 6 months prior to baseline;
  • require antibiotic treatment for dental appointments;
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  • are undergoing or require extensive dental or orthodontic treatment;
  • are pregnant or breastfeeding;
  • have rampant caries;
  • any oral or extraoral piercing in or around the oral cavity with ornaments or accessory jewelry;
  • are dental students or dental professionals;
  • have participated in a clinical dental trial in the six months preceding the study;
  • cognitive deficits.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Germany8 sites

  • Medizinische Fakultät der Humboldt Universität Berlin (Charité)

    Berlin, 13353

  • Universitätsklinikum Carl Gustav Carus, Zentrum für Zahn-, Mund- und Kieferheilkunde

    Dresden, 01307

  • Zentrum der Zahn-, Mund- und Kieferheilkunde (Carolinum), Poliklinik für Parodontologie

    Frankfurt, 60590

  • Justus-Liebig-Universität Gießen, Poliklinik für Parodontologie

    Giessen, 35392

  • Universitätsklinikum Greifswald, Poliklinik für Zahnerhaltung, Parodontologie und Kinderzahnheilkunde

    Greifswald, 17487

  • Universitätsklinikum Heidelberg, Poliklinik für Zahnerhaltungskunde, Sektion Parodontologie

    Heidelberg, 69120

  • University Hospital Muenster, Dept. of Periodontology

    Münster, 48149

  • Universität Würzburg, Poliklinik für Parodontologie

    Würzburg, 97070

Other trials in Germany

About this study

The purpose of this study is to determine the size of the benefit of an adjunctive empiric antibiotic therapy compared to standard mechanical debridement and oral hygiene instructions in a representative sample of German periodontitis patients.

Read the detailed description

Periodontitis is an endemic inflammatory disease caused by a mixed bacterial biofilm infection that is followed by destruction of tooth supporting tissues. Standard of care consists of lifelong mechanical removal of the biofilm. However, outcome is variable. According to recent EFP and AAP reviews, adjunctive antimicrobial therapy may be beneficial. We plan to conduct a double-blind, parallel group, randomized, placebo-controlled multi-center efficacy study that addresses the following objectives:

  1. What is the size of the benefit of an adjunctive empiric antibiotic therapy compared to standard mechanical debridement and oral hygiene instructions in a representative sample of German periodontitis patients?
  2. Does the administration of the antibiotic therapy delay recurrence of periodontitis in the general population and in specific high risk groups (e.g. smokers) under standard supportive therapy?
  3. Is the presence of specific microbial complexes a useful predictor of outcome and recurrence of periodontitis?
  4. Does the administration of the antibiotic therapy affect the "oral health related quality of life"?

The primary hypothesis tested is: the administered empiric adjunctive antibiotic therapy reduces about one half of the proportion of sites with attachment loss compared to subgingival debridement alone over a 27.5-month period in a statistical and clinical significant manner.

To test this hypothesis about 500 patients will be enrolled in the clinical trial. According to the intention-to-treat principle, the primary efficacy analysis will include all randomized subjects. In addition, a per-protocol analysis will be done.

Conditions
Periodontitis
Being tested
Amoxicillin and Metronidazole, Placebo
Keywords
Periodontitis, Mechanical Debridement, Antibiotics, Attachment loss, Randomized controlled trial
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amoxicillin and MetronidazoleDrug

    Also called Flagyl® 400 Filmtablette, Amoxicillin-ratiopharm® 500

    tablets: Amoxicillin 3H2O 574 mg and 400 mg metronidazole three times daily for 7 days

  • PlaceboDrug

    Placebo tablets (cellulose powder, lactose monohydrate, magnesium stearate, microcrystalline cellulose): three times daily for 7 days

Study groups in NCT00707369
Study groupRoleWhat they receive
testExperimentalMechanical debridement plus 500 mg amoxicillin and 400 mg metronidazole three times daily for 7 days. Supportive periodontal therapy in 3-month intervals.
Receives: Drug: Amoxicillin and Metronidazole
controlPlacebo comparatorMechanical debridement plus two placebo tablets three times daily for 7 days. Supportive periodontal therapy in 3-month intervals.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of sites showing attachment loss ≥ 1.3 mm over a 27.5-months period

    Measured: 27.5-months period (six measurements)

Secondary outcomes (1)

  1. Subjective perception of treatment outcome, attachment gain, pocket probing depths, bleeding on probing, and full mouth plaque score. Microbial colonization dynamic.

    Measured: over a 27.5-months period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionDec 2011
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
540 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00707369
Sponsor's protocol ID
EH 365/1-1
Other IDs
DFG grant: EH 365/1-1, ISRCTN : 64254080
Acronym
ABPARO-Studie
Status last verified
Mar 2015
First submitted
24 Jun 2008
Last updated
3 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Walther KA, Gonzales JR, Groger S, Ehmke B, Kaner D, Lorenz K, Eickholz P, Kocher T, Kim TS, Schlagenhauf U, Koch R, Meyle J. The Role of Polymorphisms at the Interleukin-1, Interleukin-4, GATA-3 and Cyclooxygenase-2 Genes in Non-Surgical Periodontal Therapy. Int J Mol Sci. 2022 Jun 30;23(13):7266. doi: 10.3390/ijms23137266.

    PubMed 35806269

  • Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.

    PubMed 33197289

  • Matern J, Koch R, Petersmann A, Kocher T, Eickholz P, Lorenz K, Kim TS, Meyle J, Kaner D, Schlagenhauf U, Gravemeier M, Harks I, Ehmke B. Effect of periodontal therapy on adipokine biomarkers in overweight. J Clin Periodontol. 2020 Jul;47(7):842-850. doi: 10.1111/jcpe.13288. Epub 2020 May 11.

    PubMed 32248552

  • Eickholz P, Koch R, Kocher T, Hoffmann T, Kim TS, Meyle J, Kaner D, Schlagenhauf U, Harmsen D, Harks I, Ehmke B. Clinical benefits of systemic amoxicillin/metronidazole may depend on periodontitis severity and patients' age: An exploratory sub-analysis of the ABPARO trial. J Clin Periodontol. 2019 Apr;46(4):491-501. doi: 10.1111/jcpe.13096. Epub 2019 Apr 12.

    PubMed 30825384

  • Kocher T, Holtfreter B, Petersmann A, Eickholz P, Hoffmann T, Kaner D, Kim TS, Meyle J, Schlagenhauf U, Doering S, Gravemeier M, Prior K, Rathmann W, Harks I, Ehmke B, Koch R. Effect of Periodontal Treatment on HbA1c among Patients with Prediabetes. J Dent Res. 2019 Feb;98(2):171-179. doi: 10.1177/0022034518804185. Epub 2018 Oct 16.

    PubMed 30326764

  • Eickholz P, Nickles K, Koch R, Harks I, Hoffmann T, Kim TS, Kocher T, Meyle J, Kaner D, Schlagenhauf U, Doering S, Gravemeier M, Ehmke B. Is furcation involvement affected by adjunctive systemic amoxicillin plus metronidazole? A clinical trials exploratory subanalysis. J Clin Periodontol. 2016 Oct;43(10):839-48. doi: 10.1111/jcpe.12594. Epub 2016 Aug 10.

    PubMed 27393928

  • Harks I, Koch R, Eickholz P, Hoffmann T, Kim TS, Kocher T, Meyle J, Kaner D, Schlagenhauf U, Doering S, Holtfreter B, Gravemeier M, Harmsen D, Ehmke B. Is progression of periodontitis relevantly influenced by systemic antibiotics? A clinical randomized trial. J Clin Periodontol. 2015 Sep;42(9):832-842. doi: 10.1111/jcpe.12441. Epub 2015 Sep 22.

    PubMed 26250060

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Amoxicillin and Metronidazole in people with Periodontitis, run by University Hospital Muenster at 8 sites 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 9 inclusion and 13 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: finished, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of sites showing attachment loss ≥ 1.3 mm over a 27.5-months period (time frame: 27.5-months period (six measurements)). 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 NCT00707369, which also lists 7 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 3 Mar 2015.

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