An interventional study of Soft tissue grafting in Bone Resorption, sponsored by University Ghent. Recruiting at 1 site in Belgium. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-03.
Sponsored by University Ghent · Not applicable, Interventional, and Treatment
Patients undergoing single immediate implant placement (IIP) in the premaxilla will be invited to participate in this randomized controlled trial (RCT). Prior to surgery, a small- field low-dose cone beam computed tomography (CBCT) is taken to verify the integrity of the facial bone wall and an adequate amount of apical and palatal bone availability for implant anchorage.
In all of the patients, a connective tissue graft (CTG) will be harvested and inserted into the buccal mucosa to increase soft tissue thickness around the immediately installed implant. However, included patients will be randomly allocated to either receive the CTG immediately after implant installation (Immediate soft tissue grafting, ISG = control group) or 3 months after implant installation (Delayed soft tissue grafting, DSG = test group).
Forty sealed envelopes are prepared for that purpose, of which 20 are internally labeled as "DSG" and 20 as "ISG". Following IIP, a sealed envelope will be opened to reveal the treatment concept In both groups, a cutting implant is installed in an optimal 3D position. Socket grafting is performed with deproteinized bovine bone mineral to limit buccal bone resorption and to optimize soft tissue stability.
In the ISG group, a pouch is made in the buccal mucosa using microsurgical instruments. Thereupon, a free gingival graft is harvested from the palatal mucosa in the premolar area and de-epithelialized to arrive at a CTG of about 1 mm thickness. Height and length are tailored to the dimensions of the site. Then, the CTG is brought into the pouch and fixed with two single sutures onto the buccal mucosa. Finally, a healing abutment is installed, which is replaced by a provisional implant crown 2 days later.
In the DSG group, implant placement, socket grafting and installation of a provisional implant crown occur as described above. In contrast, a buccal pouch is performed 3 months after implant installation. Graft harvesting, adaptation and fixation are performed as described above.
A small-field low-dose CBCT is taken at the 1-year and 5-year follow-up in order to measure buccal bone resorption as compared to the baseline dimensions in designated software.
Patients with a single failing tooth in the anterior maxilla will be included after a clinical examination and evaluation of a small-field low-dose CBCT. An intra-oral scan will be taken in order to make a surgical guide. A cutting implant with variable thread design (BLX, Straumann) will be installed using the surgical guide in order to sufficient primary implant stability.
Thereafter, the gap between the implant surface and buccal bone wall is filled with deproteinized bovine bone mineral (Bio-Oss, Gheistlich Pharma).
At this point, a closed envelope is opened and the patient gets assigned to either ISG or DSG group.
In the immediate soft tissue grafting group, a de-epithelialized free gingival graft was inserted in a buccal pouch to augment the buccal soft tissues. The graft was fixed with single sutures (Seralon 6/0, Serag Wiessner, Naila, Germany).
In the delayed soft tissue grafting group, the same procedure was performed 3 months after implant placement.
In both groups, patients received an immediate, screw-retained temporary crown. Restorations were installed within the first 48h after implant placement.
Sutures were removed 1 week after soft tissue grafting.
167 studies on the registry are indexed under Bone Resorption; 28 are open to participants now.
This study's planned enrollment of 40 is above the median of 24 across 146 interventional studies indexed under Bone Resorption.
Browse Bone Resorption studies →University Ghent is the lead sponsor of 350 studies on the registry; 86 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A connective tissue graft is immediately harvested and inserted in the buccal mucosa at the moment of implant placement
Procedure: Soft tissue grafting
Three months after implant placement, a connective tissue graft is harvested and inserted in the buccal mucosa
Procedure: Soft tissue grafting
A pouch is made in the buccal mucosa using microsurgical instruments. Thereupon, a free gingival graft is harvested from the palatal mucosa in the premolar area and de-epithelialized to arrive at a CTG of about 1 mm thickness. Height and length are tailored to the dimensions of the site. Then, the CTG is brought into the pouch and fixed with two single sutures (Seralon 6/0, Serag Wiessner, Naila, Germany) onto the buccal mucosa.
Buccal bone resorption (mm)
Changes in buccal bone dimension as measured on superimposed CBCT slides
Time frame: 1-, 5-year
Changes in buccal soft tissue profile (mm)
Changes in buccal soft tissue profile as measured on superimposed digital surface models. An intra-oral scan is taken prior to implant surgery and at 1- and 5- year follow up. On the obtained digital models, an area of interest (AOI) at the buccal aspect was drawn for each site. The AOI extends from 0.5 mm below the soft tissue margin to 4 mm more apical. In mesio-distal dimension, the AOI reaches from the mesial to the distal line angle. The AOI may vary between sites because of individual anatomic differences but must be kept constant in each site across time points. A volumetric change (mm3) was calculated by designated software within the AOI and divided by the AOI surface (mm2). This results in the mean change in buccal soft tissue profile (mm).
Time frame: 1-, 5-year
Changes in midfacial soft tissue level (mm)
Changes in buccal mucosal margin position as measured on superimposed digital surface models
Time frame: 1-, 5-year
Pink Esthetic Score
Pink Esthetic score as defined by Fürhauser et al., 2005. Within this scale, 7 variables are evaluated ( mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture) using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14. A 0 relates to the least esthetic result, while a 14 relates to a perfect outcome for all parameters.
Time frame: 1-year
Mucosal Scarring Index
Mucosal Scarring Index as defined by Wessels et al., 2019. Within this scale, 5 parameters are assessed (width, height/contour, color, suture marks, and overall appearance) using a 0-1-2 scoring system. The MSI score may range from 0 (no scar) to 10 (most extreme scar).
Time frame: 1-year
Marginal bone level changes (mm)
Changes in the distance from the implant-abutment interface to the first bone-to-implant contact (so-called marginal bone level) at the mesial and distal aspect of each implant as measured on 2D intra-oral radiographs
Time frame: 1-,5-year
Probing depth (mm)
Measured with a periodontal probe at four locations (mesio-buccal, buccal, disto-buccal and oral) around the implant at 1- and 5-year follow-up. Measurements are rounded up to the nearest 0.5 mm. A mean value is calculated per implant.
Time frame: 1-,5-year
Plaque (%)
Presence of plaque at four locations (mesio-buccal, buccal, disto-buccal and oral) around the implant. Each location is scored 0 or 1
Time frame: 1-,5-year
Bleeding on probing (%)
Presence of bleeding on probing at four locations (mesio-buccal, buccal, disto-buccal and oral) around the implant. Each location is scored 0 or 1
Time frame: 1-,5-year
Plan to share: No
Started Aug 2022 (actual). Primary completion is estimated for Jul 2024, 23 months after the start.
Of 82 non-industry interventional studies with no phase under Bone Resorption, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 23 months is close to that.
Counting every sponsor, half of 83 studies reached it within 23 months; a quarter within 12 and three quarters within 35.
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