NCT04243460

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

3.8 years

First QC Date

January 11, 2020

Last Update Submit

January 24, 2020

Conditions

Tooth Loss

Keywords

Dental Implants

Outcome Measures

Primary Outcomes (2)

  • Ultrasound examination

    ultrasound USG examination of tissue hickness

    12 months

  • Radiological examination

    RVG examination of marginal bone level change

    12 monhs

Study Arms (2)

CTG connective tissue graft augmentation

EXPERIMENTAL

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

Procedure: Connective tissue graft augmentation (CTG)

XCM Xenogeneic collagen matrix (XCM)graft augmentation

ACTIVE COMPARATOR

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

Procedure: Xenogeneic collagen matrix (XCM) graft augmentation

Interventions

Xenogeneic collagen matrix (XCM) graft augmentationPROCEDURE

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:

XCM Xenogeneic collagen matrix (XCM)graft augmentation
Connective tissue graft augmentation (CTG)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).

CTG connective tissue graft augmentation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29248711BACKGROUND

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Jakub Hadzik, PhD, DDS

    jakub.hadzik@umed.wroc.pl

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, PhD, Principal Investigator

Study Record Dates

First Submitted

January 11, 2020

First Posted

January 28, 2020

Study Start

May 1, 2012

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share