Non-surgical therapy in addition to three or seven days of amoxicillin and metronidazole treatment in patients with severe gum infection (periodontitis)

Short-term systemic antibiotics in periodontal treatment in patients suffering from aggressive periodontitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN55637591

Enrollment

Registered

2021-02-24

Start date

2015-09-01

Completion date

Unknown

Last updated

2023-04-10

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

Conditions

Non-surgical treatment of aggressive periodontitis Oral Health

Interventions

- All patients receive oral hygiene instructions and professional supragingival cleaning sessions until a full-mouth plaque score (FMPS) =25% is obtained. - Thereafter, subgingival deb

- After SD, patients are instructed to rinse for the following 2 weeks with chlorhexidine digluconate 0.2% solution and brush their teeth with chlorhexidine-digluconate toothpaste. - A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 - 36 years 2. =12 natural teeth present in the oral cavity distributed in all four quadrants 3. Clinical signs of stage III and IV grade C Periodontitis (Tonetti et al 2018) (previous aggressive periodontitis) (Armitage. 1999): interdental CAL loss =5 mm, tooth loss die to periodontitis = or =4 teeth, min. one PD =6 mm in each quadrant 4. Radiographic signs of stage III and IV grade C Periodontitis (Tonetti et al 2018): radiographic bone loss to middle or appical third of the root, vertical bone loss =3mm, % bone loss/age >1, or =2 mm bone loss in the past 5 years when older x-rays are present 5. Full-mouth plaque scores (FMPS) =25% (O'Leary et al. 1972) 6. Systemically healthy, i.e. absence of a known condition that may influence the severity or progression of periodontal disease (e.g. Down syndrome, HIV, diabetes mellitus type 1 and 2) 7. No head and neck radiation therapy 8. No infectious or heart diseases that need prophylactic administration of antibiotics before dental treatment 9. No liver disease

Exclusion criteria

Exclusion criteria: 1. Non-surgical periodontal therapy within the previous 12 months 2. Systemic or local use of antibiotics within the previous 6 months 3. Any type of systemic medication within the previous 6 months 4. Pregnancy or lactation 5. Smoking >10 cigarettes/day

Design outcomes

Primary

Measure	Time frame
Number of residual deep sites with probing depth =6 mm at 6 and 12 months	—

Secondary

Measure	Time frame
Measured at baseline, 6 and 12 months: 1. Probing pocket depths measured using patient records 2. Clinical attachment level measured using patient records 3. Bleeding on probing measured using patient records 4. Full-mouth plaque scores measured using patient records 5. Quantitative changes in investigated bacteria and inflammatory markers (sterile paper points were introduced in periodontal pockets, and then by real-time PCR and analysed using metagenome shotgun sequencing + metagenomic microbiome sequencing (for microbiology) and by ELISA test (for immunology))	—

Measure

Time frame

Measured at baseline, 6 and 12 months: 1. Probing pocket depths measured using patient records 2. Clinical attachment level measured using patient records 3. Bleeding on probing measured using patient records 4. Full-mouth plaque scores measured using patient records 5. Quantitative changes in investigated bacteria and inflammatory markers (sterile paper points were introduced in periodontal pockets, and then by real-time PCR and analysed using metagenome shotgun sequencing + metagenomic microbiome sequencing (for microbiology) and by ELISA test (for immunology))

—

Countries

Romania

Outcome results

None listed

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