Esthetics Clinical Trial
Official title:
Alveolar Ridge Preservation With Immediate or Late Implant Placement: a Multicenter Randomized Controlled Trial
Patients in need of a single implant in the premaxilla will be invited to participate in this multicenter 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 dimensions. Sixty patients will be randomly allocated to the test group or control group in 6 centers. Each center receives 10 sealed envelopes (5 are internally labelled with 'delayed implant placement' and 5 with 'immediate implant placement'). For each patient a digital planning is performed in implant planning software and a tooth-supported surgical guide is fabricated prior to tooth extraction. In the control group, alveolar ridge preservation is performed following tooth extraction. After a healing period of 4 months, a single implant is installed. In the test group, a single implant is installed immediately after tooth extraction and ridge preservation is performed by filling the gap between the facial bone wall and the implant surface. A provisional crown is placed at the day of implant surgery, which is replaced by a permanent one 3m later. Six months after tooth extraction and subsequent ridge preservation, the need for soft tissue grafting is assessed on the base of predetermined criteria (primary outcome measure). Soft tissue augmentation is performed by inserting a palatal connective tissue graft (CTG) into the buccal mucosa at the implant site. Secondary outcome measures include 3D hard and soft tissue changes as well as clinical, aesthetic, patient-reported and clinician-reported outcomes.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 1, 2028 |
Est. primary completion date | January 1, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
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-rooted tooth in the anterior maxilla (15-25) that needs to be extracted for any reason with at least one neighboring tooth present - at least 3 mm bone available at the apical or palatal aspect of the alveolus to ensure primary implant stability - intact or nearly intact buccal bone wall at the time of extraction (max 3 mm bone missing = max 6 mm distance from free gingival margin to buccal bone crest) Exclusion Criteria: - systemic diseases - smoking - untreated periodontal disease - untreated caries lesions |
Country | Name | City | State |
---|---|---|---|
Belgium | Ghent University | Ghent | Oost-Vlaanderen |
Belgium | UCL St Luc | Liège |
Lead Sponsor | Collaborator |
---|---|
University Ghent |
Belgium,
Avila-Ortiz G, Elangovan S, Kramer KW, Blanchette D, Dawson DV. Effect of alveolar ridge preservation after tooth extraction: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):950-8. doi: 10.1177/0022034514541127. Epub 2014 Jun 25. — View Citation
Bittner N, Schulze-Spate U, Silva C, Da Silva JD, Kim DM, Tarnow D, Gil MS, Ishikawa-Nagai S. Changes of the alveolar ridge dimension and gingival recession associated with implant position and tissue phenotype with immediate implant placement: A randomised controlled clinical trial. Int J Oral Implantol (Berl). 2019;12(4):469-480. — View Citation
Cosyn J, De Bruyn H, Cleymaet R. Soft tissue preservation and pink aesthetics around single immediate implant restorations: a 1-year prospective study. Clin Implant Dent Relat Res. 2013 Dec;15(6):847-57. doi: 10.1111/j.1708-8208.2012.00448.x. Epub 2012 Feb 29. — View Citation
Cosyn J, Eghbali A, Hermans A, Vervaeke S, De Bruyn H, Cleymaet R. A 5-year prospective study on single immediate implants in the aesthetic zone. J Clin Periodontol. 2016 Aug;43(8):702-9. doi: 10.1111/jcpe.12571. Epub 2016 Jun 13. — View Citation
Cosyn J, Pollaris L, Van der Linden F, De Bruyn H. Minimally Invasive Single Implant Treatment (M.I.S.I.T.) based on ridge preservation and contour augmentation in patients with a high aesthetic risk profile: one-year results. J Clin Periodontol. 2015 Apr;42(4):398-405. doi: 10.1111/jcpe.12384. Epub 2015 Mar 31. — View Citation
Kan JY, Rungcharassaeng K, Lozada JL, Zimmerman G. Facial gingival tissue stability following immediate placement and provisionalization of maxillary anterior single implants: a 2- to 8-year follow-up. Int J Oral Maxillofac Implants. 2011 Jan-Feb;26(1):179-87. — View Citation
Migliorati M, Amorfini L, Signori A, Biavati AS, Benedicenti S. Clinical and Aesthetic Outcome with Post-Extractive Implants with or without Soft Tissue Augmentation: A 2-Year Randomized Clinical Trial. Clin Implant Dent Relat Res. 2015 Oct;17(5):983-95. doi: 10.1111/cid.12194. Epub 2013 Dec 27. — View Citation
Sanz M, Lindhe J, Alcaraz J, Sanz-Sanchez I, Cecchinato D. The effect of placing a bone replacement graft in the gap at immediately placed implants: a randomized clinical trial. Clin Oral Implants Res. 2017 Aug;28(8):902-910. doi: 10.1111/clr.12896. Epub 2016 Jun 7. — View Citation
Seyssens L, Eghbali A, Cosyn J. A 10-year prospective study on single immediate implants. J Clin Periodontol. 2020 Oct;47(10):1248-1258. doi: 10.1111/jcpe.13352. Epub 2020 Sep 2. — View Citation
Yoshino S, Kan JY, Rungcharassaeng K, Roe P, Lozada JL. Effects of connective tissue grafting on the facial gingival level following single immediate implant placement and provisionalization in the esthetic zone: a 1-year randomized controlled prospective study. Int J Oral Maxillofac Implants. 2014 Mar-Apr;29(2):432-40. doi: 10.11607/jomi.3379. — View Citation
Zuiderveld EG, Meijer HJA, den Hartog L, Vissink A, Raghoebar GM. Effect of connective tissue grafting on peri-implant tissue in single immediate implant sites: A RCT. J Clin Periodontol. 2018 Feb;45(2):253-264. doi: 10.1111/jcpe.12820. Epub 2017 Dec 5. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Need for soft tissue augmentation (true or false) as judged by a panel of clinicians | The need for soft tissue augmentation is assessed by the 5 clinicians who have not been clinically involved. The treating clinician is excluded since he/she cannot be blinded for the treatment group. The need for soft tissue augmentation is assessed on the basis of clinical pictures, a CBCT image and STL file. | 6 months | |
Secondary | Clinician-reported outcome measures | Ease of implant placement (Visual Analogue Scale). Minimum value = 0 (Very easy) Maximum value = 10 (Very difficult) | per-op | |
Secondary | Changes in buccal soft tissue profile | Volumetric analysis with designated software on the basis of IOS (mm). Change in buccal soft tissue profile and the initial buccal soft tissue profile will be aggregated to calculate relative change in buccal soft tissue profile (=absolute change / initial buccal soft tissue profile, percent) | pre-op, 6 months, 1 year, 3 years, 5 years | |
Secondary | Vertical change in midfacial soft tissue level | Analysed with designated software on the basis of IOS (mm) | pre-op, 6 months, 1 year, 3 years, 5 years | |
Secondary | Change in width of the alveolar process | Horizontal measurements with designated software on the basis of CBCT scans (mm) | pre-op, 1 year, 5 year | |
Secondary | Change in height of the alveolar process | vertical measurements with designated software on the basis of CBCT scans (mm) | pre-op, 1 year, 5 year | |
Secondary | Change in buccal bone thickness | Horizontal measurements with designated software on the basis of CBCT scans (mm) | pre-op, 1 year, 5 year | |
Secondary | Implant survival | presence of the implant | 6 months, 9 months, 1 year, 3 years, 5 years | |
Secondary | Complication | Any complication | Up to 5 years | |
Secondary | Changes in radiographic outcomes | marginal peri-implant bone level change as assessed by intra-oral radiography (mm) | implant placement, 1 year, 3 years, 5 years | |
Secondary | Aesthetic outcome as assessed by care providers | Pink Aesthetic Score (0-14) = assessment of 7 different parameters (Mesial papilla, distal papilla, tissue contour, gingival level, alveolar process, coloring, texture) which are all rated 0 (worst) - 2 (best) | pre-op, 1 year, 3 years, 5 years | |
Secondary | Aesthetic outcome as assessed by patients | Patients aesthetic satisfaction (Visual Analogue Scale) Minimum value = 0 (Very unsatisfied) Maximum value = 10 (Very satisfied) | pre-op, 1 year, 3 years, 5 years | |
Secondary | Keratinized mucosa width | Vertical measurement performed with a periodontal probe (mm) | pre-op, 1 year, 3 years, 5 years | |
Secondary | Probing pocket depth | Probing depth measured with a periodontal probe (mm) | pre-op, 1 year, 3 years, 5 years | |
Secondary | Bleeding on probing | Bleeding on probing was registered 15 seconds following pocket probing at four sites per implant (mesial, distal, buccal, palatal) using a dichotomous score (0: no bleeding; 1: bleeding). These values were averaged and expressed as a percentage on implant level | pre-op, 1 year, 3 years, 5 years | |
Secondary | Plaque | Plaque was recorded at four sites per implant (mesial, distal, buccal, palatal) using a dichotomous score (0: no visible plaque at the soft tissue margin; 1: visible plaque at the soft tissue margin). These values were averaged and expressed as a percentage on implant level. | pre-op, 1 year, 3 years, 5 years |
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