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Clinical Trials/NCT04243460
NCT04243460
Completed
Not Applicable

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

Akademicka Poliklinika Stomatologiczna0 sites57 target enrollmentMay 1, 2012
ConditionsTooth Loss

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tooth Loss
Sponsor
Akademicka Poliklinika Stomatologiczna
Enrollment
57
Primary Endpoint
Ultrasound examination
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2012
End Date
March 1, 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Akademicka Poliklinika Stomatologiczna
Responsible Party
Principal Investigator
Principal Investigator

Jakub Hadzik

DDS, PhD, Principal Investigator

Akademicka Poliklinika Stomatologiczna

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

Outcomes

Primary Outcomes

Ultrasound examination

Time Frame: 12 months

ultrasound USG examination of tissue hickness

Radiological examination

Time Frame: 12 monhs

RVG examination of marginal bone level change

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