Skip to content

Non-surgical treatment of inflammation of the soft tissues around a dental implant

A single dose of piperacillin plus tazobactam pellicular coating as an adjunct to professional mechanical plaque removal in patients with peri-implant mucositis: a 6-month double-blind randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN94266769
Enrollment
40
Registered
2023-12-05
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Peri-implant mucositis Oral Health

Interventions

The study includes a cohort of 40 patients equally divided into one of the two groups – A and B. Participants will be selected from patients of the Department of Periodontology of the Victor Babes Uni
Group B [Placebo (control)]: topical application of a placebo gel, similar in aspect and consistency with the test gel. Post-application instructions for groups A and B were as follows: gentle brushi

Sponsors

MegaGen Dental Implant Romania
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Absence of relevant medical conditions 3. Partially edentulous subjects with healthy or treated periodontal conditions enrolled in a regular supportive care program 4. Peri-implant mucositis defined as =1 implant site with the presence of BoP and absence of radiographic bone loss compared with a previous radiograph (Renvert, et al., 2018) 5. Implant in function for =1 year 6. Full-Mouth Plaque Score (FMPS) =25 7. Full-Mouth Bleeding Score (FMBS) =25

Exclusion criteria

Exclusion criteria: 1. Uncontrolled medical conditions 2. Pregnant or lactating females 3. Tobacco smoking =10 cigarettes/day 4. Untreated periodontal conditions 5. Removable implant -retained prosthesis or other chronic systemic medications that could interfere with the study outcomes 6. Use of antibiotics in the past 3 months 7. Subjects treated for =2 weeks with any medication known to affect soft tissue conditions (e.g. phenytoin, calcium antagonists, cyclosporin, blood thinners and nonsteroidal anti-inflammatory drugs) within 1 month of the baseline examination 8. Failure to sign written informed consent

Design outcomes

Primary

MeasureTime frame
Implant pocket probing depth (PPD) measured from the mucosal margin to the bottom of the probable pocket and evaluated at six sites per implant (i.e., disto-buccal, mid-buccal, mesio-buccal, mesio-lingual/palatal, mid-lingual/palatal, disto-lingual/palatal) at the clinical baseline evaluation (before therapy) and the 3 and 6-month re-evaluations

Secondary

MeasureTime frame
Measured at baseline, 3 and 6 months: 1. Full mouth bleeding score (FMBS) recorded at six sites per tooth: mesiobuccal, midbuccal, distobuccal, disto-oral, midoral, and mesio-oral 2. Mean full mouth plaque score (FMPS) evaluated at six sites per tooth at 30 seconds from the survey 3. Overall bleeding index (BOP) evaluated at six sites per tooth/implant at 30 seconds from the survey 4. Number of the following five keystone bacterial pathogens measured using molecular genetic analysis, micro–IDent A Test at baseline and 3 months: 4.1. Aggregatibacter actinomycetemcomitans 4.2. Porphyromonas gingivalis 4.3. Prevotella intermedia 4.4. Tannerella forsythia 4.5. Treponema denticola

Countries

Romania

Contacts

Public ContactIoana Ilyes
ioana.veja@umft.ro+40 (0)744257097

Outcome results

None listed

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