Comparing 3 versus 7 days systemic administration of Amoxicillin (AMX) and Metronidazole (MET) in severe chronic periodontitis patients
| ISRCTN | ISRCTN17605083 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17605083 |
| Secondary identifying numbers | 514/09.01.2012 |
- Submission date
- 09/06/2015
- Registration date
- 16/06/2015
- Last edited
- 10/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Scientific
Str. Clinicilor nr 32
Cluj-Napoca
400506
Romania
Study information
| Study design | Single centre placebo controlled double masked randomized clinical interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | AMX-MET |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Amoxicillin, metronidazole |
| Primary outcome measure | 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 study start date | 01/01/2012 |
| Completion date | 01/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Sex | Both |
| Target number of participants | 102 patients |
| Total final enrolment | 102 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 30/01/2012 |
| Date of final enrolment | 30/01/2014 |
Locations
Countries of recruitment
- Romania
Study participating centre
Cluj-Napoca
4000506
Romania
Sponsor information
Hospital/treatment centre
Str. Cliniclor nr 32
Cluj Napoca
4000506
Romania
"ROR" |
https://ror.org/051h0cw83 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 31/12/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 23/06/2016 | 26/11/2021 | Yes | No | |
| Results article | 29/06/2017 | 10/07/2023 | Yes | No | |
| Results article | 01/10/2020 | 10/07/2023 | Yes | No |
Editorial Notes
10/07/2023: Publication references added.
26/11/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
