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Register:	ISRCTN
Last refreshed on:	25 July 2023
Main ID:	ISRCTN17605083
Date of registration:	16/06/2015
Prospective Registration:	No
Primary sponsor:	Department of prosthodontics, University of Medicine and Pharmacy "Iuliu Hatieganu"
Public title:	Comparing 3 versus 7 days systemic administration of Amoxicillin (AMX) and Metronidazole (MET) in severe chronic periodontitis patients
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
Date of first enrolment:	30/01/2012
Target sample size:	102
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN17605083
Study type:	Interventional
Study design:	Single centre placebo controlled double masked randomized clinical interventional trial (Treatment)
Phase:	Not Applicable

Countries of recruitment
Romania

Contacts

Name:	Raluca Cosgarea
Address:	Str. Clinicilor nr 32 400506 Cluj-Napoca Romania
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Severe chronic periodontitis
Oral Health
Severe chronic periodontitis

Intervention(s)

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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.

Secondary ID(s)

514/09.01.2012

Source(s) of Monetary Support

Philipps University of Marburg (Germany)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; 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

Results

Results available:	Yes
Date Posted:
Date Completed:	01/06/2015
URL:

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