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

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ClinicalTrials.gov Identifier: NCT04553146
Recruitment Status : Completed
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Collaborator:
Institut Straumann AG
Information provided by (Responsible Party):
Dr. France LAMBERT, University of Liege

Brief 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 up to 1 year.


Condition or disease Intervention/treatment Phase
Non-maintainable Posterior Tooth (Molars and Premolars) Procedure: Immediate implantation in posterior region with alveolar ridge preservation combined with sealing socket abutment Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 22, 2018
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : August 31, 2020

Arm Intervention/treatment
Experimental: Interventional arm
immediate implant placement in posterior sites using a custom-made sealing socket abutment combined to alveolar ridge preservation
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.




Primary Outcome Measures :
  1. Changes from baseline to 1 year of the bone remodeling : horizontal measurements (based on CBCT, in mm) [ Time Frame: Baseline to 1 year ]
    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

  2. Changes from Baseline to 1 year of the bone remodeling : vertical measurements (based on CBCT, in mm) [ Time Frame: Baseline to 1 year ]
    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.

  3. Changes from baseline to 6 months and to 1 year of the soft tissue profiles (based on intra-oral scanners, in mm) [ Time Frame: Baseline to 6 months and to 1 year ]
    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.


Secondary Outcome Measures :
  1. implant survival rate (based on criteria of Buser et al., 1990) [ Time Frame: 1 year ]
    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.

  2. Pocket depth around the implant (based on probing, in mm) [ Time Frame: 1 year ]
    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.

  3. Peri-implant bone level changes (based on periapical radiography, in mm) [ Time Frame: Baseline to 3 months and to 1 year ]
    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.

  4. Pink esthetic score (based on PES questionnaire of Furhauser et al, 2005) [ Time Frame: 1 year ]
    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).

  5. Plaque index around the implant (based on classification of Mombelli et al, 1987) [ Time Frame: 1 year ]
    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)

  6. Bleeding on Probing around the implant (based on classification of Mombelli et al, 1987) [ Time Frame: 1 year ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04553146


Locations
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Belgium
CHU University of Liège
Liège, Belgium, 4000
Sponsors and Collaborators
University of Liege
Institut Straumann AG
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Responsible Party: Dr. France LAMBERT, Head and Chair of Department, University of Liege
ClinicalTrials.gov Identifier: NCT04553146    
Other Study ID Numbers: H2017-BLX
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No