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

Not Applicable

Completed

• Conditions: Peri-implant mucositis; Oral Health

• Registration Number: ISRCTN94266769
• Lead Sponsor: MegaGen Dental Implant Romania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-09-01
• Study Start: 2023-12-05
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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