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Treatment of peri-implant diseases with enamel matrix proteins

Application of enamel matrix derivate, deproteinized bovine bone and collagen membrane for the reconstructive treatment of periimplant intrabony defect: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18159776
Enrollment
40
Registered
2021-04-15
Start date
2021-04-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Intraosseous peri-implant defects Surgery

Interventions

Surgical procedures will be performed 1 month after non-surgical periodontal treatment. On the same day of surgical therapy an antibiotic will be administered for 7 days (amoxicillin 500 mg / 7 days /

Sponsors

ThinkingPerio Research
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Patients with diabetes mellitus, hyperparathyroidism and/or osteomalacia 2. Patients treated with corticosteroids 3. Patients medicated with drugs that induce gingival hyperplasia 4. Allergic to penicillin or who have taken antibiotics in the last 6 months 5. Pregnant or breastfeeding 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) in six locations per implant, measured by probing from the margin of the peri-implant mucosa to the most apical part of the peri-implant defect with a manual periodontal probe at baseline and at 6 and 12 months

Secondary

MeasureTime frame
1. Filling of the radiographic defect measured using intraoral radiographs of the implant at baseline, 6 months and 12 months 2. Mucosal recession measured at one vestibular point of each implant from the apical margin of the implant-supported restoration to the margin of the peri-implant mucosa with a manual periodontal probe at baseline, at 6 months and at 12 months 3. Bleeding on probing measured with a manual periodontal probe in six locations per implant in basal at 6 months and 12 months 4. Plaque control measured with a manual periodontal probe in six locations per implant in basal at 6 months and 12 months 5. Patient satisfaction and morbidity measured using a visual analogue scale (VAS) at 2 weeks, 6 months and 12 months 6. Volumetric changes measured using an intraoral scanner and a digital computer program at baseline, at 6 months and 12 months

Countries

Spain

Outcome results

None listed

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