Removal of the attached biofilm and calculus from dental implant surface Oral Health
Conditions
Interventions
Current interventions as of 06/10/2025:
Surgical procedures will be performed one month after non-surgical periodontal treatment. On the same day of surgical therapy an antibiotic will be administered
Sponsors
Arrow Development S.L.
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Measured at 4, 12, 24 and 48 weeks: 1. Radiographic filling of the defect will be measured with Image J Software 2. Risk of appearance of complications measured with a questionnaire recording suppuration, membrane exposure or grafting material exposure and soft tissue dehiscence. 3. Patient-reported outcomes measurements: patient pain perception and general satisfaction with surgical procedure and final outcomes. 4. Need for analgesia after surgery measured using patient records 5. Intervention time measured using patient records 6. Soft and hard tissue volumetric changes measured with an intraoral scanner and compared with implant planning software 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 | — |
Countries
Spain
Outcome results
None listed