Clinical trial NCT04243460: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Loss
Keywords: Dental Implants
Lead sponsor: Akademicka Poliklinika Stomatologiczna
Sponsor class: OTHER
Collaborators: name: Camlog Oral Reconstruction Foundation
name: Wrocław Medical University
First posted: 2020-01-28
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ultrasound examination
timeFrame: 12 months
measure: Radiological examination
timeFrame: 12 monhs
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: jakub.hadzik@umed.wroc.pl
name: Jakub Hadzik, PhD, DDS
role: PRINCIPAL_INVESTIGATOR
References:
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.