Comparison of two adjunctive systemic antibiotic regimens to initial therapy for periodontitis patients

Clinical, microbiological and oxidative stress evaluation of periodontitis patients treated with two regimens of systemic antibiotics, adjunctive to non-surgical therapy. A placebo-controlled randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12816166

Enrollment

Registered

2019-03-31

Start date

2017-10-01

Completion date

Unknown

Last updated

2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic periodontitis Oral Health Chronic periodontitis

Interventions

All patients were investigated clinically and radiographically at baseline (before therapy). The following clinical parameters were assessed: periodontal pocket depth (PPD), clinical attachment level

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women >25 years of age 2. No periodontal therapy or antibiotic intake in the previous 6 months 3. At least 10 natural teeth present in the oral cavity clinically distributed in all four quadrants 4. Bleeding on probing 5. At least 6 teeth with at least one site each with pocket depth (PD) = 5 mm at baseline 6. Clinic and radiographic signs of generalized chronic periodontitis (Armitage 1999)

Exclusion criteria

Exclusion criteria: 1. Pregnancy and/or lactation 2. Any known allergy to antibiotics (amoxicillin, metronidazole) 3. Any systemic conditions that could affect the progression and treatment of periodontal diseases such as Diabetes Mellitus types 1 and 2 4. Medication that could interact with amoxicillin or metronidazole such as coumarin derivates, alcohol derivates, 5-fluor-uracyl/ disulfiram derivates, amprenavir oral solutions, lopinavir/ritonavir oral solution, methotrexate, tetracyclines, oral contraceptives, mebendazole, busulfan, timidazole, vitamin K antagonists, barbiturats, lithium, phenytoin, calcium channel blockers 5. Alcohol abuse

Design outcomes

Primary

Measure	Time frame
Periodontal pocket depth measured with a periodontal probe (PCPUNC 15, Hu-Friedy, Chicago, IL, USA) at baseline (initial evaluation) and after three months	—

Secondary

Measure	Time frame
Measured at baseline (initial evaluation) and after three months: 1. Clinical attachment level measured at six sites per tooth (mesio-buccal, buccal, disto-buccal, disto-lingual, lingual and mesio-lingual) at all teeth, excluding third molars, to the nearest millimeter with a periodontal probe (PCPUNC 15, Hu-Friedy, Chicago, IL, USA), using the cement–enamel junction as a reference point for the clinical attachment level. 2. Plaque assessed with the full-mouth plaque score (FMPS) 3. Bleeding assessed with the full-mouth bleeding score (FMBS) 4. Number of sites with PPD =6 mm (considered deep periodontal pockets) measured with a periodontal probe (PCPUNC 15, Hu-Friedy, Chicago, IL, USA) 5. Microbiological parameters evaluated through polymerase chain reaction (PCR) testing using the commercial micro-Ident® kit (Hain Lifescience GmbH, Nehren, Germany) and microbial resistance using the Epsilometer technique (E-test®, AB Biodisk, Solna, Sweden) 6. Biochemical parameters assessed from plasma samples, analyzing the reactive oxygen metabolites and the biological antioxidant potential through photometric methods (Diacron International®, Grosseto, Italy)	—

Measure

Time frame

Measured at baseline (initial evaluation) and after three months: 1. Clinical attachment level measured at six sites per tooth (mesio-buccal, buccal, disto-buccal, disto-lingual, lingual and mesio-lingual) at all teeth, excluding third molars, to the nearest millimeter with a periodontal probe (PCPUNC 15, Hu-Friedy, Chicago, IL, USA), using the cement–enamel junction as a reference point for the clinical attachment level. 2. Plaque assessed with the full-mouth plaque score (FMPS) 3. Bleeding assessed with the full-mouth bleeding score (FMBS) 4. Number of sites with PPD =6 mm (considered deep periodontal pockets) measured with a periodontal probe (PCPUNC 15, Hu-Friedy, Chicago, IL, USA) 5. Microbiological parameters evaluated through polymerase chain reaction (PCR) testing using the commercial micro-Ident® kit (Hain Lifescience GmbH, Nehren, Germany) and microbial resistance using the Epsilometer technique (E-test®, AB Biodisk, Solna, Sweden) 6. Biochemical parameters assessed from plasma samples, analyzing the reactive oxygen metabolites and the biological antioxidant potential through photometric methods (Diacron International®, Grosseto, Italy)

—

Countries

Romania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026