About this trial
This study is being done to see which of two common grafting techniques-mixing two different grafting materials or layering two grafting materials-works better to augment bone volume next to your dental implant(s). We want to know which technique results in better bone augmentation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Minimum dentition of 20 permanent teeth
Single edentulous site at maxillary premolar, canine, lateral incisor, or central incisor
Adjacent teeth present with sufficient clearance for an implant crown
Ridge width between 4 mm and 7 mm at the edentulous site
Disqualifiers
Current heavy smokers (>10 cigarettes per day) or heavy smokers who quitted less than 1 year
Pregnancy or lactating mothers
Diseases of the immune system or any medical condition that may influence the treatment outcome (for examples uncontrolled diabetes (HbA1c >7), uncontrolled cardiovascular disease, neurologic or psychiatric disorders, systemic infections, history of radiation therapy in the head and neck area, current use of oral bisphosphonates for >3 years or history of IV bisphosphonates use, current alcoholism or drug abuse, etc.)
Acute infection at/or adjacent to the edentulous site (e.g., sinus tract, swelling, etc.)
Trial design
Parallel
Treatments tested in this trial
Sandwich bone augmentation
Procedure/SurgeryThe exposed threads on the buccal side of the implant will be grafted with three distinct layers of grafting materials.
Mixed bone augmentation
Procedure/SurgeryThe exposed threads on the buccal side of the implant will be grafted with three grafting materials mixed together.
Treatment groups
Trial outcomes
Primary outcomes
Horizontal Bone Gain (mm) Measured by Cone-Beam Computed Tomography (CBCT)
Horizontal bone gain will be measured in millimeters (mm) by comparing CBCT images obtained at baseline and follow-up. Measurements will be performed using computer-based imaging software to quantify changes in horizontal alveolar ridge width at the treated site.
Secondary outcomes
Implant Survival Assessed by Clinical Examination
Implant survival will be assessed by the treating provider through clinical examination at the specified follow-up time point. An implant will be considered surviving if it remains present and in function at the time of evaluation.
Pink Esthetic Score (PES) Assessed by a Blinded Examiner
Peri-implant esthetic outcomes will be evaluated by a blinded examiner using the Pink Esthetic Score (PES). The PES will be determined according to the predefined components of the scoring system, with higher scores indicating a more favorable peri-implant soft-tissue esthetic outcome.
Sponsors and contacts
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University of California, San Francisco
Lead sponsor
Geistlich Pharma AG
Collaborator
This trial is not recruiting at the moment. You can still explore other options: