Clinical and Dimensional Outcomes of Sealing Socket Abutment Combined to Alveolar Ridge Preservation

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04553146
• Other study ID #: H2017-BLX
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 22, 2018
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2023
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Study population Hopeless maxillary or mandibular molars with tooth anatomy and bone anchorage allowing an immediate implant procedure: apical bone height of at least 5 mm or presence of interradicular septum, socket with intact bone walls, absence a large apical periodontitis, Patients needing tooth replacement in the posterior region (molars) will be recruited from the Department of Periodontology and Oral and Implant Surgery of the University of Liège, Belgium. Procedures After a local anesthesia, one of the two experienced surgeons (LF or LG) proceeded to the least traumatic extraction of the concerned tooth. The consecutive drills for implant placement were carried out while considering the future position of the crown for a screw- retained restoration. Twenty BLX implants (Roxolid®, SLAactive®, Institut Straumann AG) were placed flapless with a sufficient apical or septum anchorage and the insertion torque was recorded. The gap around the implant was filled with deproteinized bovine bone mineral (DBBM) (cerabone®, botiss biomaterials GmbH). Just after the implant placement, an intra-oral scan (IOS) (Trios 3®, 3-Shape) with a scanbody connected onto the implant platform was performed and sent to the dental laboratory to digitally design (Dental Wings®) a customized healing abutment. The SSA was then milled (CARES®, Institut Straumann AG) from a block of PEEK (JUVORATMPEEK, JUVORATM Ltd. National Distributor: Institut Straumann AG), cemented to a titanium abutment (Variobase®, Institut Straumann AG) and provided to the patient on the same day. During manufacturing of the SSA, a conventional healing abutment was screwed on the implant and a collagen sponge (Collaplug®) was provisionally placed buccally to protect the exposed biomaterial until the placement of the SSA. A standardized parallel peri-apical radiograph using a custom-made film holder was taken in order to record the baseline bone level. Each patient was instructed to rinse twice daily with an aqueous solution of 0.2% chlorhexidine (Corsodyl®, GSK) and to avoid brushing of the area until the first recall 10-12 days later. Anti-inflammatories (Ibuprofen® 600 mg) and additional analgesics (Paracetamol® 500 mg) were prescribed and taken according to the patient's needs. If the surgeon deemed it necessary, an anti- biotic was prescribed (Amoxicillin® 500mg 3x/day during 5 days). Three months after implantation, the abutment was removed, the osseointegration of the implant was checked and the final lithium aluminosilicate ceramic reinforced with lithium disilicate monolithic crown (n!ce® glass-ceramic block, Institut Straumann AG) based on the initial IOS was cemented to a titanium abutment (Variobase®, Institut Straumann AG) and placed. The transmucosal design from the SSA was replicated on the final crown. Follow-up evaluations and data recording will be performed 7-10 days, 3 months, 6 months, 12 months, 3years and 5years after the surgery.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Non-maintainable Posterior Tooth (Molars and Premolars)

Intervention

Procedure:
• Immediate implantation in posterior region with alveolar ridge preservation combined with sealing socket abutment
Twenty BLX? Straumann immediate implants were placed flapless. The gap around the implant was filled with xenogeneic biomaterial. An intra-oral scanner was performed and sent to the dental laboratory to digitally design a customized healing abutment. The abutment was then milled from a block of PEEK and placed a couple of hours later in the clinic. Three months after implantation, the abutment was removed and the final monolithic crown based on the initial IOS was placed. The transmucosal design from the SSA was replicated on the final crown.

Locations

Country	Name	City	State
Belgium	CHU University of Liège	Liège

Sponsors (2)

Lead Sponsor	Collaborator
University of Liege	Institut Straumann AG

Country where clinical trial is conducted

Belgium, 

Outcome

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