No registrations found.
ID
Source
Brief title
Health condition
one-stage alveolar ridge augmentation
dental implants
membranes
randomized controlled trial
Sponsors and support
Department of Oral & Maxillofacial Surgery, Special Dental Care and Orthodontics, Erasmus University Medical Centre, Rotterdam, the Netherlands and St. Anna Hospital, Geldrop, the Netherlands.
Intervention
Outcome measures
Primary outcome
Level of the marginal bone around the implant at least 12 months after loading
Secondary outcome
Outcomes scored:
1.the plaque index (PI),
2.the bleeding index BI,
3.the gingiva index (GI),
4.the pocket probing depth (PPD),
5.the width of the attached mucosa (WAM)
6. Peri-implant esthetic score (PES) reflects the following five items: mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, and root convexity/soft tissue color and texture at the facial aspect of the implant site.
7 White esthetic score (WES) is based on the five following items: general tooth form; outline and volume of the clinical crown; color, which includes the assessment of the dimension’s hue and value; surface texture; and translucency and characterization
8. Questionnaire about patient satisfaction (VAS)
9. Adverse events and complications
Reported as:
Implant survival, implant succes, clinical assessment, aesthetic assessment, patient satisfaction
Background summary
Several systematic reviews report on the success of implants placed in one-stage ridge augmentation procedures (bone augmentation simultaneous with implant placement) (Chiapasco & Zaniboni 2009, Kuchler & von Arx 2014). However, these systematic reviews can’t reach consensus about the beneficial use of a membrane in one-stage ridge augmentation procedures. Currently there are only two randomized controlled trials comparing one-stage ridge augmentations with and without membranes (Fu, et al. 2014, Park, et al. 2008). These two studies concluded that the addition of a barrier membrane prevented horizontal buccal bone resorption and enhanced bone thickness. No effect was seen on implant survival at one year. These studies describe large defects and fail to mention parameters of implant success and soft tissue aesthetics. In our clinical experience, there is no need for membranes in small buccal bony dehiscences, which can be managed by solely using locally harvested autogenous bone and bone substitutes. Therefore the aim of this of this randomized controlled trial is to determine the effect of membranes on small one-stage bone augmentations on implant survival, implant success, clinical and radiographic parameters, aesthetic results and patient satisfaction. The study is designed as a multicenter, prospective, randomized clinical trial (RCT). The study takes place at the University Medical Centre Erasmus MC, Rotterdam and the St. Anna Hospital, Geldrop.
Study objective
The hypothesis is that small buccal dehiscences after implant placement can be reconstructed with a mixture of a bone substitute and autogenous bone with and without coverage of a membrane.
-Our second hypothesis is that implants with a small buccal bony dehiscence after implant placement reconstructed by one-stage bone augmentation perform equally well as implants completely covered in pristine bone
Study design
pre-operative, two weeks post operative, 6 weeks post operative and 1, 6 and > 12 months after placement of the crown.
Intervention
Group A: the bony defect after implant placement is reconstructed with a mixture of autogenous bone and Straumann bone ceramic and covered with a membrane (Membragel)
Group B: the bony defect after implant placement is reconstructed with a mixture of autogenous bone and Straumann bone ceramic without use of a membrane
Group C: patients without bony dehiscence after implant placement are treated in a 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
1) Over 18 years of age
2) Need for an implant-supported crown to replace a maxillary tooth at the location of an incisor, cupsid or first/second bicuspid
3) Single tooth diastema as a maximum
4) Presence of a small bone deficiency of equal to or less than 4 mm
5) Sufficient occlusal and mesio-distal dimensions for insertion of one implant with a functional prosthetic restoration.
Exclusion criteria
1) Presence of clinical active periodontal disease. 2) Presence of an acute inflammatory oral disease.
3) Smoking.
4) Diabetes.
5) A history of radiotherapy in the head-and-neck region or current chemotherapy
6) Disability (mental and/or physical) to maintain basic oral hygiene procedures.
7) 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 | NL5956 |
| NTR-old | NTR6137 |
| CCMO | NL34657.078.11 |
| OMON | NL-OMON41609 |