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The effect of membranes on small, bone augmentations at dental implant placement


- candidate number25518
- NTR NumberNTR6137
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-nov-2016
- Secondary IDsNL 34657.078.11 MEC 2011.039 METC ErasmusMC
- Public TitleThe effect of membranes on small, bone augmentations at dental implant placement
- Scientific TitleSmall buccal dehiscences at implant placement can be reconstructed with a mixture of Straumann bone ceramic and autogenous bone covered with Membragel: a 1-year prospective randomized multicenter clinical study
- ACRONYMMembragel study
- hypothesisThe 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
- Healt Condition(s) or Problem(s) studiedImplants
- Inclusion criteria1) 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 criteria1) 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2011
- planned closingdate1-feb-2017
- Target number of participants75
- InterventionsGroup 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
- Primary outcomeLevel of the marginal bone around the implant at least 12 months after loading
- Secondary outcomeOutcomes 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 dimensionís 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
- Timepointspre-operative, two weeks post operative, 6 weeks post operative and 1, 6 and > 12 months after placement of the crown.
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES B.P. Jonker
- CONTACT for SCIENTIFIC QUERIES B.P. Jonker
- Sponsor/Initiator Erasmus Medical Center, Department Oral and Maxillofacial Surgery, St. Anna Hospital
- Funding
(Source(s) of Monetary or Material Support)
Straumann AG, Basel, Switzerland
- PublicationsN/A
- Brief summarySeveral 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 canít 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.
- Main changes (audit trail)
- RECORD9-nov-2016 - 3-jan-2017


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