Influence of Soft Tissue Thickness on the Bone Level Around Implants

January 24, 2020 updated by: Jakub Hadzik, Akademicka Poliklinika Stomatologiczna

Influence of Soft Tissue Thickness on the Marginal Bone Level Around Implants in Esthetic Zone: 1 Year Randomized Control Trail

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CTG connective tissue graft augmentation
CTG connective tissue graft (CTG) was used for soft tissue augmentation. I
Procedure: Connective tissue graft augmentation (CTG)
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).
Active Comparator: XCM Xenogeneic collagen matrix (XCM)graft augmentation
Xenogeneic collagen matrix (XCM) was used for soft tissue augmentation.
Procedure: Xenogeneic collagen matrix (XCM) graft augmentation

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:

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound examination
Time Frame: 12 months
ultrasound USG examination of tissue hickness
12 months
Radiological examination
Time Frame: 12 monhs
RVG examination of marginal bone level change
12 monhs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akademicka Poliklinika Stomatologiczna

Collaborators

Camlog Foundation
Wrocław Medical University

Investigators

  • Principal Investigator: Jakub Hadzik, PhD, DDS, jakub.hadzik@umed.wroc.pl

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2012

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 11, 2020

First Submitted That Met QC Criteria

January 24, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 24, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STT and MBL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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