NCT03358667

Brief Summary

The objective of this observational study is to evaluate the growth of peri-implant soft tissues using an heterologous dermal membrane graft (group A) or a 2 mm healing screw used as a vertical support of the limbs (group B) positioned at the moment of surgical insertion of the implant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

November 1, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2021

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

November 25, 2017

Last Update Submit

March 25, 2021

Conditions

Alveolar Bone Loss

Keywords

peri-implant soft tissue augmentation

Outcome Measures

Primary Outcomes (1)

  • soft tissue width

    measurement of the full thickness flap

    6 months after surgery

Secondary Outcomes (1)

  • implant survival rate

    two years from surgery

Study Arms (2)

group A

single edentulism implant insertion tent screw 2mm augmentation peri-implant soft tissue

Procedure: augmentation peri-implant soft tissue

group B

single edentulism implant insertion cover screw and membrane augmentation peri-implant soft tissue

Procedure: augmentation peri-implant soft tissue

Interventions

augmentation peri-implant soft tissuePROCEDURE

the implant was cover with a 2 mm cover screw for a tent effect or with a dermal membrane after implant insertion

group Agroup B

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

thin peri-implant biotype; one implant for one patient

You may qualify if:

  • indications for implant insertion into the posterior mandible based on careful diagnosis and treatment plan;
  • presence of a residual bone crest with a minimum surgical height of 7 mm and a thickness of at least 6 mm at the programmed implant sites;
  • the bone crest must be cured (at least 6 months after the loss / extraction of the corresponding dental element);
  • Soft tissue height above the implant ≤ 2mm;
  • no regenerated bone;
  • Plaque index below 25% and bleeding index less than 20%;
  • buco-lingual amplitude of the adherent gingiva ≥ 4 mm;
  • age of the patient\> 18 years;
  • patients should be able to examine and understand the study protocol;
  • informed consent.

You may not qualify if:

  • acute myocardial infarction in the last 2 months;
  • uncompensated coagulation turbines;
  • unmanaged diabetes (HbA1c\> 7.5%);
  • head / neck district radiotherapy for the last 24 months;
  • immunocompromised patients (HIV infection or chemotherapy over the last 5 years);
  • present or past treatment with intravenous bisphosphonates;
  • psychological or psychiatric problems;
  • abuse of alcohol and / or drugs;
  • smokers
  • \) non-controlled periodontal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piezosurgery Academy

Parma, 43100, Italy

Location

Related Publications (2)

  • Puisys A, Vindasiute E, Linkevciene L, Linkevicius T. The use of acellular dermal matrix membrane for vertical soft tissue augmentation during submerged implant placement: a case series. Clin Oral Implants Res. 2015 Apr;26(4):465-470. doi: 10.1111/clr.12401. Epub 2014 Apr 30.

    PMID: 24779749BACKGROUND

  • Suarez-Lopez Del Amo F, Lin GH, Monje A, Galindo-Moreno P, Wang HL. Influence of Soft Tissue Thickness on Peri-Implant Marginal Bone Loss: A Systematic Review and Meta-Analysis. J Periodontol. 2016 Jun;87(6):690-9. doi: 10.1902/jop.2016.150571. Epub 2016 Jan 16.

    PMID: 26777766BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

soft tissue harvesting during second stage surgery

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Claudio Stacchi, Dr

    Piezosurgery Academy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of the International Piezosurgery Academy

Study Record Dates

First Submitted

November 25, 2017

First Posted

November 30, 2017

Study Start

November 1, 2017

Primary Completion

October 31, 2019

Study Completion

March 25, 2021

Last Updated

March 26, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)