Condition category
Oral Health
Date applied
09/06/2015
Date assigned
16/06/2015
Last edited
17/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic periodontitis is an inflammatory disease mainly initiated by bacteria residing in biofilms at and below the gingival margins. It affects the tissues surrounding the teeth involving progressive loss of the tooth supporting structures. Initial treatment includes the removal of bacterial deposits from the tooth structures through mechanical cleaning called scaling and root planning (SRP). Because bacteria are found in areas that hard to reach, SRP does not remove all bacteria and antibacterial agents (antibiotics and antiseptics) are also used. The aim of the present study is to evaluate the clinical outcomes following non-surgical periodontal therapy (performed within 24 hours) in conjunction with adjunctive Amoxicillin (AMX) and Metronidazole (MET) administered systemically for 3 and 7 days in patients with severe chronic periodontitis.

Who can participate?
Adults over 30 with severe chronic periodontitis

What does the study involve?
Participants are randomly allocated to one of three treatment groups:
- control group: non-surgical periodontal treatment (SRP) within 24 hours and dummy pills (3 times daily) for 7 days
- antibiotic group 1: SRP within 24h, then the following 3 days Amoxicilline and Metronidazole (both 500 mg 3 times daily), and then for another 4 days dummy pills (3 times daily)
- antibiotic group 2: SRP within 24h, then the following 7 days Amoxicilline and Metronidazole (both 500 mg 3 times daily)

What are the possible benefits and risks of participating?
This is a low risk study. All participants receive periodontal treatment.

Where is the study run from?
University of Medicine and Pharmacy "IUliu Hatieganu" Cluj Napoca (Romania)

When is the study starting and how long is it expected to run for?
January 2012 to June 2015

Who is funding the study?
University of Medicine and Pharmacy "IUliu Hatieganu" Cluj Napoca (Romania)

Who is the main contact?
Dr Raluca Cosgarea

Trial website

Contact information

Type

Scientific

Primary contact

Dr Raluca Cosgarea

ORCID ID

Contact details

Str. Clinicilor nr 32
Cluj-Napoca
400506
Romania

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

514/09.01.2012

Study information

Scientific title

A randomized controlled clinical study on non-surgical periodontal treatment in conjunction with 3 versus 7 days systemic administration of Amoxicillin and Metronidazole in severe chronic periodontitis patients

Acronym

AMX-MET

Study hypothesis

The null hypothesis to be tested in this RCT is “no difference in the treatment effect regarding the difference in the number of deep pockets (PD≥ 6 mm) for the systemic use of Amoxicillin and Metronidazole administered for 3 days compared with the administration of the same antibiotics for 7 days adjunctive to SRP”.

Ethics approval

Ethics Committee (Comisia de etica) of the University of Medicine and Pharmacy "Iuliu Hatieganu", Cluj-Napoca, Romania, 20/01/2012, ref 514/09.01.2012

Study design

Single centre placebo controlled double masked randomized clinical interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Severe chronic periodontitis

Intervention

All patients received oral hygiene instructions and cleanings.
Three treatment procedures were performed according to a computer generated randomisation list:
- control group: non-surgical periodontal treatment (scaling and root planing SRP) within 24 hours and placebo pills (3 times daily) for 7 days
- antibiotic group 1: SRP within 24h, then the following 3 days Amoxicilline (AMX) and Metronidazole (MET)- both for 500 mg (3 times daily), and then for another 4 days placebo pills (3 times daily)
- antibiotic group 2: SRP within 24h, then the following 7 days Amoxicilline (AMX) and Metronidazole (MET)- both for 500 mg (3 times daily)
All patients rinsed their mouths for the following 2 weeks with chlorhexidine digluconate 0.2% solution and used tooth paste with 0.2% chlorhexidine digluconate.
Clinical periodontal parameters (probing pocket depth, clinical attachment level, bleeding on probing, furcation involvement, full-mouth plaque score -FMPS-, gingival bleeding index -GBI), sulcus fluid for microbiological and immunological determinations were determined at baseline, at 2 weeks, at 3, 6 and 12 months after treatment.
Patients were asked about their compliance for the pills intake and adverse effects.

Intervention type

Drug

Phase

Drug names

Amoxicillin, metronidazole

Primary outcome measures

Difference of the number of sites per patient with pocket depth ≥ 6 mm between baseline and 6 months

Secondary outcome measures

Secondary variables were changes in: probing pocket depth, clinical attachment level, bleeding on probing, furcation involvement, full-mouth plaque score -FMPS-, gingival bleeding index -GBI, number of sites per patient with PD ≥ 6 mm, number of sites per patient ≥ 5 mm, bacterial load of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tanerella Forsythia, Treponema denticola, Prevotella intermedia, levels of IL-10. IL-1ß, TNF-alpha, MMP-8.

Overall trial start date

01/01/2012

Overall trial end date

01/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. >30 years
2. Diagnosis of severe chronic periodontitis (Armitage 1999)
3. ≥ 12 natural teeth
4. ≥ 1 site/quadrant with pocket depth ≥ 6mm
5. Full-mouth plaque scores ≤ 25% (O`Leary 1972)
6. systemically healthy
7. No allergies for penicillin or 5-nitroimidazole derivates

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

102 patients

Participant exclusion criteria

1. Non-surgical periodontal therapy within 12 months
2. Systemic/local antibiotics within the previous 3 months
3. Medication that could interact with amoxicilline or metronidazole
4. Pregnancy/lactation

Recruitment start date

30/01/2012

Recruitment end date

30/01/2014

Locations

Countries of recruitment

Romania

Trial participating centre

Clinic for Prosthodontics, University of Medicine and Pharmacy "Iuliu Hatieganu"
Str. Clinicilor nr 32
Cluj-Napoca
4000506
Romania

Sponsor information

Organisation

Department of prosthodontics, University of Medicine and Pharmacy "Iuliu Hatieganu"

Sponsor details

Str. Cliniclor nr 32
Cluj Napoca
4000506
Romania

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Philipps University of Marburg (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish our results in highly ranked international dental journals.
Preliminary data and final results of this trial have already been presented at several international congresses:
- annual meeting of the German Society of Periodontology where it was awarded with the best ORL presentation for clinical research 2014
- EuroPerio 2015 where it was selected between the first 3 studies for the Jaccard Prize Competition
- CED-Continental Division of the IADR-International Association for Dental Research Oct 2014 Antalya.

Intention to publish date

31/12/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes