Treatment of peri-implant diseases with enamel matrix proteins

Not Applicable

• Conditions: Intraosseous peri-implant defects; Surgery

• Registration Number: ISRCTN18159776
• Lead Sponsor: ThinkingPerio Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-15
• Last Update Posted: 16 October 2023
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Filling of the radiographic defect measured using intraoral radiographs of the implant at baseline, 6 months and 12 months<br>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<br>3. Bleeding on probing measured with a manual periodontal probe in six locations per implant in basal at 6 months and 12 months<br>4. Plaque control measured with a manual periodontal probe in six locations per implant in basal at 6 months and 12 months<br>5. Patient satisfaction and morbidity measured using a visual analogue scale (VAS) at 2 weeks, 6 months and 12 months<br>6. Volumetric changes measured using an intraoral scanner and a digital computer program at baseline, at 6 months and 12 months