Influence of Soft Tissue Thickness on the Bone Level Around Implants

NCT ID: NCT04243460

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-01
• Study Completion Date: 2016-03-01

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.

Conditions

Tooth Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CTG connective tissue graft augmentation

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

Group Type: EXPERIMENTAL

Connective tissue graft augmentation (CTG)

Intervention Type: PROCEDURE

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).

XCM Xenogeneic collagen matrix (XCM)graft augmentation

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

Group Type: ACTIVE_COMPARATOR

Xenogeneic collagen matrix (XCM) graft augmentation

Intervention Type: PROCEDURE

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:

Interventions

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:

Intervention Type: 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).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Camlog Oral Reconstruction Foundation

OTHER

Sponsor Role: collaborator

Wrocław Medical University

UNKNOWN

Sponsor Role: collaborator

Akademicka Poliklinika Stomatologiczna

OTHER

Sponsor Role: lead

Responsible Party

Jakub Hadzik

DDS, PhD, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jakub Hadzik, PhD, DDS

Role: PRINCIPAL_INVESTIGATOR

jakub.hadzik@umed.wroc.pl

References

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.

Reference Type: BACKGROUND

PMID: 29248711 (View on PubMed)

Other Identifiers

STT and MBL

Identifier Type: -

Identifier Source: org_study_id