About this trial
Dental implants are a fixed replacement solution with reported long-term survival rates between 94-98% over 20-40 years. In order to ensure successful implant therapy, adequate bone and soft tissue as well as correct 3D positioning of the implant are required. Upon extraction of a tooth, socket width can decrease by up to 60% within six months post-extraction, with a 11-22% vertical reduction. Additionally, sinus pneumatization occurs post-extraction as the maxillary sinus expands into the empty socket due to disuse atrophy and intra-sinus air pressure, as explained by Wolff's law. This further reduces residual bone height (RBH), often resulting in posterior maxillary sites requiring supplemental procedures to prevent bone loss or to augment the bone height at the time of implant placement. However, if the bone height and width dimensions are sufficient before and after extraction - in that, even with the aforementioned loss in width and height percentages in the latter, a standard implant may still be placed in the surrounding bone, one can argue that grafting may not be necessarily done at the time of extraction. Rather, it can be tailored to the patients' needs; thus potentially reducing overall post-operative discomfort and pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Intact or <5mm dehiscence buccally and palatally
Initial residual bone height (RBH) of at least 6 mm. 3-A minimum distance of 1 mm between root apices and sinus membrane.
Disqualifiers
Medically compromised
heavy smokers
young (<18 yrs.) or those refusing treatment are excluded.
Trial design
Parallel
Treatments tested in this trial
Ossix mineralized grafting immediately at extraction
Other interventionAfter surgical extraction, the socket is grafted using Ossix mineralized bone graft and covered with Ossix Plus membrane with standard suturing.
Delayed grafting at implant placement
Other interventionExtraction sites heal without grafting. At implant placement (T3), augmentation-if needed based on ridge width or residual bone height-is performed using Ossix bone graft and Ossix Agile membrane.
Treatment groups
Trial outcomes
Primary outcomes
Patient reported outcomes (PROMs) and perception by using of Oral Health Impact Profile-14 (OHIP-14)
The OHIP-14 is a 14-question survey that measures how oral health problems affect a person's quality of life, assessing aspects like pain, discomfort, and limitations in daily activities across seven domains (functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap). A 5-point Likert scale is used for responses, and scores are summed (0-56). Higher scores indicate worse oral health impact.
Secondary outcomes
To compare the clinical outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating bone thickness.
Measurements will be conducted using a caliper (mm) and periodontal probe (UNC probe in mm).
To compare the clinical outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating soft tissue vertical thickness.
Measurements will be conducted using a caliper (mm) and periodontal probe (UNC probe in mm).
To compare the clinical outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating soft tissue horizontal thicknesses.
Measurements will be conducted using a caliper (mm) and periodontal probe (UNC probe in mm).
To compare the radiographic outcomes of immediate versus delayed grafting in maxillary molar extraction sites restored with dental implants evaluating sinus pneumatization.
Radiographic outcomes will be measured through vertical and volumetric bone changes and sinus pneumatization assessed through pre- and post-operative CBCT (in mm)
Sponsors and contacts
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Virginia Commonwealth University
Lead sponsor
Dentsply Sirona Inc.
Collaborator