Influence of Soft Tissue Thickness on the Bone Level Around Implants

Akademicka Poliklinika Stomatologiczna

Status: Completed

Conditions: Tooth Loss

Treatments: Procedure: Xenogeneic collagen matrix (XCM) graft augmentation; Procedure: Connective tissue graft augmentation (CTG)

Study type: Interventional

Funder types: Other

Identifiers

NCT04243460

STT and MBL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 2 patient groups

CTG connective tissue graft augmentation

Experimental group

Description:

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

Treatment:

Procedure: Connective tissue graft augmentation (CTG)

XCM Xenogeneic collagen matrix (XCM)graft augmentation

Active Comparator group

Description:

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

Treatment:

Procedure: Xenogeneic collagen matrix (XCM) graft augmentation