Dental implant surface cleaning with hydrogen bubbles
Not Applicable
- Conditions
- Oral HealthRemoval of the attached biofilm and calculus from dental implant surface
- Registration Number
- ISRCTN17197337
- Lead Sponsor
- Arrow Development S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
1. Age = 18 years
2. Peri-implant bone defect =3 mm assessed radiographically
3. Peri-implant pocket depth (PPD) =5 mm combined with bleeding on probing or suppuration
4. Intra-surgically, bone defect must have at least an intraosseous component of 3 mm and a width of no more than 4mm
5. Implants =1 year in function
Exclusion Criteria
1. Treated for peri-implantitis during the previous 6 months
2. Intake of systemic or local antibiotics during the previous 6 months
3. Pregnant patients
4. Systemically unhealthy patients
5. Patients allergic to collagen
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A composite definition of successful treatment outcome defined as the absence of bleeding or suppuration on probing, absence of peri-implant probing depth =5 mm and mucosal recession =1 mm at 4, 12, 24 and 48 weeks. One calibrated examiner will perform the assessments. The following variables will be assessed at four sites around the implant: Plaque, probing pocket depth (PPD), bleeding on probing (BoP), probing attachment level (PAL) recession (REC). Keratinized mucosa (KM) will be measured in the buccal aspect of each included implant
- Secondary Outcome Measures
Name Time Method Measured at 4, 12, 24 and 48 weeks:<br>1. Radiographic filling of the defect will be measured with Image J Software<br>2. Risk of appearance of complications measured with a questionnaire recording suppuration, membrane exposure or grafting material exposure and soft tissue dehiscence.<br>3. Patient-reported outcomes measurements: patient pain perception and general satisfaction with surgical procedure and final outcomes.<br>4. Need for analgesia after surgery measured using patient records<br>5. Intervention time measured using patient records <br>6. Soft and hard tissue volumetric changes measured with an intraoral scanner and compared with implant planning software<br>7. Impact of defect configuration in treatment outcomes; taking into account the presence or absence of buccal bony wall and the number of bony walls the researchers will perform a further analysis of the impact of these defects in the final reconstructive outcomes