Alveolar ridge preservation with a xenograft and a collagen matrix or a free connective tissue graft versus spontaneous healing: A 1-year prospective randomized clinical trial.

Recruiting

Conditions: Oral implants, alveolar ridge preservation

Registration Number: NL-OMON22864

Lead Sponsor: Erasmus Medical Center, Department Oral and Maxillofacial Surgery<br><br>Catharina Hospital Eindhoven, Department Oral and Maxillofacial Surgery

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 75

Inclusion Criteria

Over 18 years of age. Need for an implant-supported dental crown to replace a maxillary tooth at the location of an incisor, cuspid or first/second bicuspid; single tooth diastema as a maximum; intact buccal bone plate (confirmed by clinical examination); sufficient occlusal and mesio-distal dimensions for insertion of one implant with a functional prosthetic restoration.

Exclusion Criteria

Presence of clinical active periodontal disease; presence of an acute inflammatory oral disease; smoking; uncontrolled diabetes; a history of radiotherapy in the head- and-neck region or current chemotherapy; disability (mental and/or physical) to maintain basic oral hygiene procedures; under eighteen years of age.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The level of the buccal marginal gingiva (one year after implant loading)

Secondary Outcome Measures

Name	Time	Method
1. Peri-implant esthetic score (PES)<br /><br>2. White esthetic score (WES)<br /><br>3. Labial soft tissue volume (using impressions)<br /><br>4. The marginal bone level around the implants/ Distance from implant shoulder to first bone-to-implant contact (MBL/DIB) using a standardized digital intra-oral radiograph<br /><br>5. Evaluation of facial bone wall (using CBCT)<br /><br>6. The plaque index (PI)<br /><br>7. The bleeding index (B)<br /><br>8. The gingiva index (GI)<br /><br>9. The pocket probing depth (PPD)<br /><br>10. The width of the attached mucosa (WAM)<br /><br>11. Patient’s satisfaction about the esthetical result of the crown and peri-implant tissue<br /><br><br /><br>Tertiary: Implant succes