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ID
Source
Brief title
Health condition
Oral implants, alveolar ridge preservation
Sponsors and support
<br>
Catharina Hospital Eindhoven, Department Oral and Maxillofacial Surgery
Straumann AG, Basel, Switzerland
Intervention
Outcome measures
Primary outcome
The level of the buccal marginal gingiva (one year after implant loading)
Secondary outcome
1. Peri-implant esthetic score (PES)
2. White esthetic score (WES)
3. Labial soft tissue volume (using impressions)
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
5. Evaluation of facial bone wall (using CBCT)
6. The plaque index (PI)
7. The bleeding index (B)
8. The gingiva index (GI)
9. The pocket probing depth (PPD)
10. The width of the attached mucosa (WAM)
11. Patient’s satisfaction about the esthetical result of the crown and peri-implant tissue
Tertiary: Implant succes
Background summary
Replacement of a single tooth in the esthetic zone is a demanding procedure. The application of a biomaterial in the extraction socket, covered with a collagen matrix or a soft tissue graft may lead to less vertical and horizontal changes of the alveolar ridge and soft-tissues and thereby simplifying the procedure with more predictable outcomes.
The study is a prospective randomized clinical trial with 1-year follow-up. Patients in need for an implant-supported dental crown to replace a maxillary tooth in the esthetic zone are randomized in one of three techniques: A) bone substitute material and a collagen matrix B) bone substitute material covered with a palatal graft, or C) spontaneous healing. After extraction of the tooth, patients will be treated according to their assigned protocol. After 8 weeks a Straumann implant will be placed. The implants are loaded after a minimum healing time of approximately 8-10 weeks. Esthetic and clinical parameters and patient satisfaction is assessed after tooth extraction, before implant placement and up to one year after crown placement. Esthetic scores consist of the Peri-implant esthetic score (PES) and the White esthetic score (WES). Labial soft tissue volume is assessed using digitized casts; the buccal bone is assessed using Cone Beam CT scans. Other assessments are the buccal marginal gingiva, marginal bone level (MBL), plaque index (PI), the bleeding index BI, the gingiva index (GI), the pocket probing depth (PPD) and the width of the attached mucosa (WAM). A patient’s questionnaire includes a visual analog scales (VAS) that will focus on expectation and satisfaction of the surgical procedure and about the esthetic result of the dental crown and the peri-implant tissue.
Study objective
Alveolar ridge preservation with a xenograftand a collagen matrix or a free connective tissue graft, compared to spontaneous healing, leads to better soft tissue and bone volume for early implant placement and a better aesthetic result, up to 1 year after functional loading.
Study design
Pre-operative, one week post extraction, implant placement, 2 weeks after implant placement 1, 6 and > 12 months after placement of the crown.
Intervention
Group A) Placement of a bone substitute material (deproteinized bovine bone mineral with 10% collagen; Bio-Oss Collagen®, Geistlich) covered with a collagen matrix (Geistlich Mucograft® Seal).
Group B) Placement of a bone substitute material (deproteinized bovine bone mineral with 10% collagen; Bio-Oss Collagen®, Geistlich) covered with a punch biopsy of the palate.
Group C) Spontaneous healing (control group).
B.P. Jonker
Erasmus MC Rotterdam
P.O. Box 2040, 3000 CA Rotterdam, the Netherlands
's-Gravendijkwal 230, Office D-224
Rotterdam
The Netherlands
Tel + 31 10 703 4138
e-mail: b.jonker@erasmusmc.nl
B.P. Jonker
Erasmus MC Rotterdam
P.O. Box 2040, 3000 CA Rotterdam, the Netherlands
's-Gravendijkwal 230, Office D-224
Rotterdam
The Netherlands
Tel + 31 10 703 4138
e-mail: b.jonker@erasmusmc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6497 |
| NTR-old | NTR6685 |
| CCMO | NL49965.078.14 |
| OMON | NL-OMON42186 |