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

Not Applicable

Completed

• Conditions: on-surgical treatment of aggressive periodontitis; Oral Health

• Registration Number: ISRCTN55637591
• Lead Sponsor: Iuliu Ha?ieganu University of Medicine and Pharmacy

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35781888/ results (added 30/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-01
• Study Start: 2021-02-24
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of residual deep sites with probing depth =6 mm at 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
<br> Measured at baseline, 6 and 12 months:<br> 1. Probing pocket depths measured using patient records<br> 2. Clinical attachment level measured using patient records<br> 3. Bleeding on probing measured using patient records<br> 4. Full-mouth plaque scores measured using patient records<br> 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))<br>