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Reconstructive surgical therapy of peri-implantitis bone defects

Reconstructive surgical therapy of peri-implantitis-related bone defects: Application of a bovine-derived bone xenograft with or without a resorbable collagen membrane. Multicenter controlled randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN67095066
Enrollment
40
Registered
2019-06-03
Start date
2019-07-01
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Intraosseous peri-implant defects Oral Health

Interventions

The test group will be treated with xenograft cover with a resorbable collagen membrane. Control group will be treated with xenograft only. The intervention will we realized in a single session and

Sponsors

Periocentrum Bilbao
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Show radiographically peri-implant intraosseous defects of at least 3mm depth. 2. Depth of clinical probing = 5mm with bleeding and/or suppuration. 3. Intra-surgically, the infra-osseous defect must have at least one intraosseous component of 3mm and a width of no more than 4mm. 4. The implant to be treated must have been in function for at least 12 months.

Exclusion criteria

Exclusion criteria: 1. Has diabetes mellitus, hyperparathyroidism and/or osteomalacia. 2. Treated with corticosteroids. 3. Medicated with drugs that induce gingival hyperplasia. 4. Allergic to penicillin or who have taken antibiotics in the last 6 months. 5. Pregnant or breast-feeding patients. 6. Patients with osteoporosis. 7. Impossibility of stabilizing bovine bone with collagen or primary closure of soft tissue. 8. Patients with collagen allergy. 9. Patients treated with radiotherapy.

Design outcomes

Primary

MeasureTime frame
Probing depth (PS) is measured in 6 locations per implant. It consists of probing from the margin of the peri-implant mucosa to the most apical part of the peri-implant defect at baseline, at 6 months and at 12 months.

Secondary

MeasureTime frame
1. Filling of the radiographic defect is measured using intraoral radiographs of the implant at baseline, 6 months and 12 months. The defect that is appreciated in the initial radiography with the filling in the following ones will be compared. 2. Mucosal recession is measured at one vestibular point of each implant. Measured from the apical margin of the implant-supported restoration to the margin of the peri-implant mucosa at baseline, at 6 months and at 12 months. 3. Bleeding on probing is measured in 6 locations per implant in basal at 6 months and 12 months. 4. Plaque control is measured in 6 locations per implant in basal at 6 months and 12 months. 5. Presence of complications is measured using membrane exposure at healing period. It will be checked if there is primary closure of the lesion or if there is membrane exposure. 6. Intervention time. Is measured by a chronometer since the first incision until the last suture. 7. Patient satisfaction and morbidity are measured using a visual analogic scale at 2 weeks, 6 months and 12 months to know the postoperative morbidity and perception and satisfaction with the procedure. 8. Volumetric changes are measured using an intraoral scanner and a digital computer program that superimposes an initial scanner with the posterior ones to see the volumetric changes at baseline, at 6 months and 12 months.

Countries

Spain

Outcome results

None listed

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