Hard and Soft Tissue Maintenance Around Implants With a Sloped Configuration (NCT04712565) | Clinical Trial Compass
CompletedNot Applicable
Hard and Soft Tissue Maintenance Around Implants With a Sloped Configuration
Austria40 participantsStarted 2021-01-14
Plain-language summary
This study is a controlled, randomized clinical trial over about 16-months (active phase). 40 patients in need of replacement of a single tooth with a minimal crestal bone width of 4 - 5mm and suitable for simultaneous GBR (Guided Bone Regeneration) procedure as well as at least a neighboring tooth on its mesial aspect will be consecutively recruited at the Department of Dental Medicine and Oral Health Graz. Volunteers will be screened and eligible subjects will be randomized to two different groups. In group 1 implants with regular neck design (Astra Tech Implant EV C, Dentsply Implants Manufacturing GmbH, Hanau, Germany) and GBR procedure (BioOss® and BioGide®, Geistlich, Wolhusen, Schweiz) fixed with two membrane pins (Hipp Medical AG, Kolbingen, Germany) will be used; in group 2 implants with sloped marginal configuration (Astra Tech Implant Profile EV C, Dentsply Implants Manufacturing GmbH, Hanau, Germany) without bone augmentation are used. The dimension of the bony defect and amount of lingual-buccal bone height discrepancy (max. 5mm) respectively bone width will be evaluated using a 3-D volume tomography (Planmeca ProMax® 3D Max, Planmeca, Helsinki, Finland), which is needed for digital planning (Simplant Planning Software, Leuven, Belgium) of the implant position, length and diameter as well.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion Criteria:
* Written consent after clarification
* capability of giving an informed consent
* good health as defined by the subjects medical history (no contraindications as described in the exclusion criteria below)
* age 18 years of age and over
* Good periodontal status: BOP \< 20%, PI \< 30%, no PD \> 4mm
* No heavy smokers (\< 10 cigarettes/day)
* At least 1 missing tooth in the premolar and molar region (in selected cases in the frontal area) either in the maxilla or in the mandible requiring implant therapy for reconstruction.
* implant site must present a buccal bone defect not extending a lingual-buccal or buccal-palatinal height discrepancy of 5mm and a sufficient bone width for simultaneously GBR procedure
* implant site must present at least a neighbouring tooth on its mesial aspect
Exclusion Criteria:
* Insufficient bone volume for implant placement requiring a sinus floor elevation or extensive bone augmentation
* Heavy Smokers (\>10 cigarettes/day)
* Medication with a contraindication for implant therapy
* Skeletal immaturity
* Any active malignancy or ongoing treatment for malignancy
* An active infection at the operative site
* Contraindications to the class of drugs which are used at regular surgical procedures, e.g. known hypersensitivity or allergy to class of drugs or the investigational product, except penicillin-allergy
* Pregnancy
* unable or unwilling to return for follow-up visits for a period of at least 16 months