Non-maintainable Posterior Tooth (Molars and Premolars) Clinical Trial
Official title:
Immediate Implant Placement in the Posterior Region Combining Socket Seal Abutment and Alveolar Ridge Preservation: Implant, Hard and Soft Tissue Outcomes After 1 Year, 3 Years and 5 Years
Verified date | April 2023 |
Source | University of Liege |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
objectives The aim of this study was to assess the implant outcomes as well as hard and soft tissue dimensional changes of immediate implant placement in posterior sites using a custom-made sealing socket abutment (SSA) combined to alveolar ridge preservation (ARP). Material and methods Twenty posterior teeth were immediately replaced with implants in 20 patients. The remaining sockets were filled with Deproteinized Bovine Bone Mineral. Based on intra-oral scanners (IOS), custom-made SSAs were placed the same day. CBCT and IOS were performed to monitor hard and soft tissue dimensional changes. Moreover, implant survival rate, peri-implant bone changes, peri-implant health and pink esthetic score were recorded at 1 year, 3years and 5 years.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | August 31, 2025 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - good general health (ASA I/II), - more than 18 years old, - non smoker, - one hopeless tooth, - healthy periodontal condition, - the presence of at least 2 mm of keratinized gingiva, - adequate plaque control (FMPS = 25%), adequate bone quantity in the septum if present and at least 5 mm of bone in the apical region Exclusion Criteria: - auto-immune disease or immunocompromised patients, - uncontrolled diabetes, - use of steroids or biphosphonates, - local or systemic infection (medical treatment needed prior to entrance to the study), pregnancy or breastfeeding, alcoholism or chronically drug abuse. Local exclusion criteria: - bone availability requiring an angulated abutment, - untreated local inflammation, - cyst, - mucosal disease or oral lesions, - local irradiation therapy, - oral communication with sinus after the extraction. |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU University of Liège | Liège |
Lead Sponsor | Collaborator |
---|---|
University of Liege | Institut Straumann AG |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from baseline to 1 year of the bone remodeling : horizontal measurements (based on CBCT, in mm) | The measurements were done by matching and superimposing CBCT using a three dimensional reconstruction software. The measures were performed from implant platform to 7 mm below this reference line. Bucco-palatal remodeling, buccal remodeling and palatal/lingual remodeling were measured | Baseline to 1, 3 and 5 years | |
Primary | Changes from Baseline to 1 year of the bone remodeling : vertical measurements (based on CBCT, in mm) | The measurements were done by matching and superimposing CBCT using a three dimensional reconstruction software. Four vertical measurements were taken : on the buccal side, on the lingual side, and in mesial and distal of the implant, under the contact points. | Baseline to 1, 3 and 5 years | |
Primary | Changes from baseline to 6 months and to 1 year of the soft tissue profiles (based on intra-oral scanners, in mm) | Intra-oral scanners were performed at baseline, 6 months and 1 year and were superimposed using a specific software. The buccal and lingual/palatal measurements were done perpendicular to the soft tissue profile at gingival margin and every mm below until 4 mm. The recession was measure as the vertical distance between the gingival margin at the different time points. | Baseline to 1, 3 and 5 years | |
Secondary | implant survival rate (based on criteria of Buser et al., 1990) | Success was defined according to the criteria of Buser et al., 1990 which are 1. absence of suppuration (recurring peri implant infection) 2. absence of persistent complaints like pain, foreign body sensation and/or dysesthesia 3. absence of continuous radioluncency area around the implant 4. absence of implant mobility. | Baseline to 1, 3 and 5 years | |
Secondary | Pocket depth around the implant (based on probing, in mm) | PD was measured by means of a periodontal probe (CP 15 UNC, Hu-Friedy, Chicago, IL, USA) at 6 sites per implant and rounded off to the nearest millimeter. | Baseline to 1, 3 and 5 years | |
Secondary | Peri-implant bone level changes (based on periapical radiography, in mm) | The peri-implant bone levels were assessed on periapical radiography using the parallel technique: the linear distance between the implant shoulder of the bone level implants and the first bone to implant contact (DIB, mm) was measured at the mesial and distal aspects using the specific software Image J64 (National Institutes of Health, Bethesda, MD, USA). Final DIB values were recorded as the average of the obtained mesial and distal values. | Baseline to 1, 3 and 5 years | |
Secondary | Pink esthetic score (based on PES questionnaire of Furhauser et al, 2005) | The PES compares the peri-implant soft tissue conditions to the respective features present at the contralateral natural tooth site. A score of 0, 1 or 2 was assigned to each parameter (mesial and distal papilla, soft tissue contour, soft tissue level, alveolar process, soft tissue coloring and texture), the highest possible score being 14, as described by Fürhauser et al (Fürhauser et al., 2005). | Baseline to 1, 3 and 5 years | |
Secondary | Plaque index around the implant (based on classification of Mombelli et al, 1987) | The plaque index was scored according to Mombelli 1987 (0 = no detection of plaque; 1 = plaque only recognized by running a probe across the smooth marginal surface of the implant, 2 = plaque can be seen by the naked eye, 3 = abundance of soft matter) | Baseline to 1, 3 and 5 years | |
Secondary | Bleeding on Probing around the implant (based on classification of Mombelli et al, 1987) | The bleeding on probing was scored according to Mombelli 1987 (0 = no bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant; 1 = isolated bleeding spots visible, 2 = Blood forms a confluent red line on margin, 3 = heavy or profuse bleeding) | Baseline to 1, 3 and 5 years |