Guided Bone Regeneration Clinical Trial
Official title:
A Randomized Controlled Trial Comparing Guided Bone Regeneration With Connective Tissue Graft to Re-establish Buccal Convexity at Implant Sites: Three-year Results.
NCT number | NCT05143242 |
Other study ID # | 23-186 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | April 2021 |
Verified date | December 2021 |
Source | University Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The most frequent aesthetic complication following single implant treatment seems to be a lack of buccal convexity. This 'alveolar process deficiency' is the result of buccal bone remodeling following tooth extraction. A traditional approach to treat alveolar process deficiency is guided bone regeneration (GBR), however post-operative complications such as swelling, bleeding and pain are common and the aesthetic outcome may not be optimal. An alternative to the traditional GBR approach could be soft tissue contour augmentation using a connective tissue graft (CTG) at the buccal aspect. Possible advantages over GBR include less morbidity at the implant site, a superior aesthetic outcome since there is no need for vertical releasing incisions and less costs since there are no biomaterials to be used. The primary study objective is to compare the GBR and CTG group in terms of 2 and 3 dimensional tissue alterations, focusing on the amount of tissue gain and volume stability over time. The secondary study objectives are morbidity, overall radiographic, clinical and aesthetic outcomes.
Status | Completed |
Enrollment | 42 |
Est. completion date | April 2021 |
Est. primary completion date | March 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - At least 18 years old. - Good oral hygiene defined as full-mouth plaque score = 25% (O'Leary et al.1972 - Presence of a single tooth gap in the anterior maxilla (15 - 25) with both neighbouring teeth present - Failing tooth at least 3 months earlier removed - Class I defect at the single tooth gap as clinically assessed (buccopalatal loss of tissue with a normal apicocoronal ridge height) (Seibert, 1983) - Signed informed consent - Buccopalatal bone dimension of at least 6 mm at the central and crestal aspect of the single tooth gap to ensure complete embedding of an implant by bone Exclusion Criteria: - Systemic diseases - Smoking - (History of) periodontal disease - Untreated caries lesions - Need for horizontal bone augmentation at the time of implant placement |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University Ghent |
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Buccal soft tissue profile | The volumetric analysis software (Swissmeda/SMOP, Zürich, Switzerland) calculated a mean dimensional change (mm3) within the AOI (area of interest) for each patient at T5 (3 years). Given the variable size in AOI (mm2) among patients, the mean dimensional change per area was transformed to a mean linear change in buccal soft tissue profile (BSP) in mm. | Year 1 and 3 | |
Secondary | Midfacial recession | Midfacial recession was registered between 6 months, 1 year and 3 years on the basis of digital surface models in STL format superimposed and imported in designated software (Swissmeda/SMOP, Zürich, Switzerland). Midfacial recession was calculated by subtracting the data from 1 and 3 years to 6 months of follow-up. | Month 6; Year 1 and 3 | |
Secondary | Buccal bone thickness | The thickness of the buccal bone was measured (in mm) at t2 (1 year) and t3 (3 years) perpendicular to the long axis of the implant. Buccal bone was measured from the implant surface to the bone-soft tissue interface at 3 levels. | Year 1 and 3 | |
Secondary | Buccal soft tissue thickness | The thickness of the soft tissues was measured (in mm) at t2 (1 year) and t3 (3 years) perpendicular to the long axis of the implant. Buccal soft tissue thickness was measured from the bone-soft tissue interface to the buccal soft tissue outline at the same levels as buccal bone thickness. | Year 1 and 3 | |
Secondary | Pink Esthetic Score | The PES awards 7 parameters: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue colour, soft tissue texture. Each parameter is assessed with a 0-1-2 score, yielding a PES score ranging from 0 (worst aesthetic outcome) to 14 (perfect aesthetic outcome). | Year 1 and 3 | |
Secondary | Mucosal Scarring Index | The MSI is a composite index based on five parameters: width, height/contour, colour, suture marks and overall appearance. Each parameter is assessed with a 0-1-2 score, yielding an MSI score ranging from 0 (no scar) to 10 (most extreme scar). | Year 1 and 3 | |
Secondary | Marginal bone loss | Marginal bone loss was recorded at the mesial and distal aspect of each implant. The distance from the implant-abutment interface to the first bone-to-implant contact (so-called bone level) was assessed on peri-apical radiographs taken with the long-cone paralleling technique. Mesial and distal values were averaged to receive one value per implant. | Year 1 and 3 | |
Secondary | Probing depth | Probing depth was registered at four locations (mesiobuccal, buccal, distobuccal and palatal) around the implant to the nearest 0.5 mm. A mean value was calculated per implant. | Year 1 and 3 | |
Secondary | Plaque | Plaque was assessed at four locations (mesiobuccal, buccal, distobuccal and palatal) around the implant. Each location was scored 0 or 1 (the absence or presence of plaque, respectively). Plaque was expressed as a percentage. | Year 1 and 3 | |
Secondary | Bleeding on probing | Bleeding on probing was assessed at four locations (mesiobuccal, buccal, distobuccal and palatal) around the implant. Each location was scored 0 or 1 (the absence or presence of bleeding, respectively). Bleeding on probing was expressed as a percentage. | Year 1 and 3 |
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