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Influence of Soft Tissue Thickness on the Bone Level Around Implants

Primary Purpose

Tooth Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Xenogeneic collagen matrix (XCM) graft augmentation
Connective tissue graft augmentation (CTG)
Sponsored by
Akademicka Poliklinika Stomatologiczna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Loss focused on measuring Dental Implants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

To qualify for the study, the patients had to be >18 years and have missing teeth in the esthetic zone. Additional inclusion criteria were as follows:

  • missing single or double teeth in the anterior area of their upper or lower jaw with a proper inter arch relationship (incisors, canines and first premolar) with a ridge width (bucco-lingual) greater than 5 mm at its narrowest point and a minimum keratinized gingiva height of 2 mm buccally.
  • No previous soft tissue augmentation procedure at experimental site

Exclusion Criteria:

The criteria that disqualified patients from the study were previous grafting procedures in the area of interest and systemic or local diseases that could compromise healing or osteointegration. Smokers and patients with bruxism were also excluded from the study. Additional exclusion criteria were as follows:

  • implants placed with an insertion torque of 35 Ncm or less;
  • irradiation in the head and neck area;
  • untreated periodontitis;
  • poor oral hygiene (plaque score Approximal Plaque Index (API) 20%, bleeding score 10%) and
  • poor motivation;
  • fresh post extraction sockets

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    CTG connective tissue graft augmentation

    XCM Xenogeneic collagen matrix (XCM)graft augmentation

    Arm Description

    CTG connective tissue graft (CTG) was used for soft tissue augmentation. I

    Xenogeneic collagen matrix (XCM) was used for soft tissue augmentation.

    Outcomes

    Primary Outcome Measures

    Ultrasound examination
    ultrasound USG examination of tissue hickness
    Radiological examination
    RVG examination of marginal bone level change

    Secondary Outcome Measures

    Full Information

    First Posted
    January 11, 2020
    Last Updated
    January 24, 2020
    Sponsor
    Akademicka Poliklinika Stomatologiczna
    Collaborators
    Camlog Oral Reconstruction Foundation, Wrocław Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04243460
    Brief Title
    Influence of Soft Tissue Thickness on the Bone Level Around Implants
    Official Title
    Influence of Soft Tissue Thickness on the Marginal Bone Level Around Implants in Esthetic Zone: 1 Year Randomized Control Trail
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2012 (Actual)
    Primary Completion Date
    March 1, 2016 (Actual)
    Study Completion Date
    March 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Akademicka Poliklinika Stomatologiczna
    Collaborators
    Camlog Oral Reconstruction Foundation, Wrocław Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Healthy soft tissue around the implant are considered as a biological seal to prevent inflammatory periimplant diseases and ensure healthy, stable and long-term survival of a dental implant. Due to the fact that the measurement methods in the literature differ, it is necessary to establish objective measurement method and to determine the minimum amount of tissue thickness to maintain a stable level of bone around the implant.
    Detailed Description
    Healthy soft tissue around the implant are considered as a biological seal to prevent inflammatory periimplant diseases and ensure healthy, stable and long-term survival of a dental implant. Due to the fact that the measurement methods in the literature differ, it is necessary to establish objective measurement method and to determine the minimum amount of tissue thickness to maintain a stable level of bone around the implant. Purpose: The aim of the study was to determine the effect of soft tissues in the implant area on the marginal bone level loss in the implant area and to define of the critical gingival thickness to minimize marginal bone level (MBL) loss. Materials and methods: 75 bone level implants (Conelog® Camlog, Switzerland) were inserted in the aesthetic area. Thickening of soft tissues was performed both before and after implantation (group II and III), CTG and XCM were used (subgroup a and b). 12 months after the loading with final restoration, the thickness of soft tissues in the implant area was examined with ultrasonography (USG) device (Pirop®, Echoson, Poland), and each implant was subjected to Radiovisiography (RVG) RVG examination, where MBL loss was determined.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Loss
    Keywords
    Dental Implants

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    57 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CTG connective tissue graft augmentation
    Arm Type
    Experimental
    Arm Description
    CTG connective tissue graft (CTG) was used for soft tissue augmentation. I
    Arm Title
    XCM Xenogeneic collagen matrix (XCM)graft augmentation
    Arm Type
    Active Comparator
    Arm Description
    Xenogeneic collagen matrix (XCM) was used for soft tissue augmentation.
    Intervention Type
    Procedure
    Intervention Name(s)
    Xenogeneic collagen matrix (XCM) graft augmentation
    Intervention Description
    12 months after gingival augmentation Measurement of marginal bone level and soft tissue thickness were done. STT (soft tissue thickness) was measured using ultrasonography with a Pirop® dental, ultrasound device (Echoson Company, Poland). The patients underwent a clinical and ultrasound examination before, 3 and 12 months after gingival augmentation (GA) respectively to evaluate TKT at two points using ultrasound equipment (Pirop®, Echoson). Intraoral radiographs were taken using a paralleling technique with a Rinn-type film holder in high resolution mode (Visualixe HD®, Gendex®, USA). Two images of each region were selected to calculate the marginal bone changes:
    Intervention Type
    Procedure
    Intervention Name(s)
    Connective tissue graft augmentation (CTG)
    Intervention Description
    12 months after gingival augmentation Measurement of marginal bone level and soft tissue thickness were done. STT (soft tissue thickness) was measured using ultrasonography with a Pirop® dental, ultrasound device (Echoson Company, Poland). The patients underwent a clinical and ultrasound examination before, 3 and 12 months after gingival augmentation (GA) respectively to evaluate STT (soft tissue thickness) at two points using ultrasound equipment (Pirop®, Echoson).
    Primary Outcome Measure Information:
    Title
    Ultrasound examination
    Description
    ultrasound USG examination of tissue hickness
    Time Frame
    12 months
    Title
    Radiological examination
    Description
    RVG examination of marginal bone level change
    Time Frame
    12 monhs

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: To qualify for the study, the patients had to be >18 years and have missing teeth in the esthetic zone. Additional inclusion criteria were as follows: missing single or double teeth in the anterior area of their upper or lower jaw with a proper inter arch relationship (incisors, canines and first premolar) with a ridge width (bucco-lingual) greater than 5 mm at its narrowest point and a minimum keratinized gingiva height of 2 mm buccally. No previous soft tissue augmentation procedure at experimental site Exclusion Criteria: The criteria that disqualified patients from the study were previous grafting procedures in the area of interest and systemic or local diseases that could compromise healing or osteointegration. Smokers and patients with bruxism were also excluded from the study. Additional exclusion criteria were as follows: implants placed with an insertion torque of 35 Ncm or less; irradiation in the head and neck area; untreated periodontitis; poor oral hygiene (plaque score Approximal Plaque Index (API) 20%, bleeding score 10%) and poor motivation; fresh post extraction sockets
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jakub Hadzik, PhD, DDS
    Organizational Affiliation
    jakub.hadzik@umed.wroc.pl
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29248711
    Citation
    Puzio M, Blaszczyszyn A, Hadzik J, Dominiak M. Ultrasound assessment of soft tissue augmentation around implants in the aesthetic zone using a connective tissue graft and xenogeneic collagen matrix - 1-year randomised follow-up. Ann Anat. 2018 May;217:129-141. doi: 10.1016/j.aanat.2017.11.003. Epub 2017 Dec 15.
    Results Reference
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    Influence of Soft Tissue Thickness on the Bone Level Around Implants

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