Increase of Peri-implant Soft Tissues With Screw or Membrane (DERMA)

March 25, 2021 updated by: Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy

Comparison Between Dermal Matrix Membrane and Tent-screw Technique for Vertical Increase of Peri-implant Soft Tissues

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The presence of soft tissue over the implants plays an important role both in bone preservation and in enhancing aesthetic conditions. The importance of good quality and amount of soft tissues was indicated by colleagues in 1994: the soft tissue enhancement technique involved inserting, at the site of the implant, a connective tissue graft taken from the palate of the patient itself. The technique was intended to allow a better aesthetic result in the treated area and to prevent metal exposure in case of reabsorption of the vestibular bone. In a systematic review of literature, some authors in 2014 have shown that a soft tissue graft applied to the implant placement area will provide a better aesthetic result. Colleagues in 2010 tested the increase in thickness of peri-implant tissues in a randomized and controlled split-mouth study: at the time of implant placement, a site received a connective plug and one received no graft. The average thickness increase in the grafted sites was 1.3 mm and allowed for aesthetic improvement.

In recent years, some human or animal origin materials have been introduced to replace the connective tissue which, being taken by the patient, often binds to a second surgical area with increased morbidity, postoperative discomfort and longer duration of intervention same. The use of deproteinized human dermis was first introduced in plastic surgery in 1995 and ophthalmic in 1999 in the second half of the 90s and then in oral surgery. Recently colleagues used the deproteinized dermis of human origin, placed at the same time as the implants, to evaluate whether the thickening of peri-implant tissues reduced marginal bone resorption after prosthetic loading. Their study showed that areas receiving an insertion had a reduced marginal bone resorption compared to areas with thin soft tissues, without quantifying the increase in soft tissues. In another prospective study, Lorenzo and colleagues in 2011 compared the connective tissue taken from the palate to a dermal matrix of porcine origin to obtain an increase in keratinized tissue bandage: the two techniques yielded similar results. Even in this case, however, the vertical thickness increase of soft tissues was not evaluated.

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Parma, Italy, 43100
        • Piezosurgery Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

thin peri-implant biotype; one implant for one patient

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. acute myocardial infarction in the last 2 months;
  2. uncompensated coagulation turbines;
  3. unmanaged diabetes (HbA1c> 7.5%);
  4. head / neck district radiotherapy for the last 24 months;
  5. immunocompromised patients (HIV infection or chemotherapy over the last 5 years);
  6. present or past treatment with intravenous bisphosphonates;
  7. psychological or psychiatric problems;
  8. abuse of alcohol and / or drugs;
  9. smokers

11) non-controlled periodontal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group A
single edentulism implant insertion tent screw 2mm augmentation peri-implant soft tissue
Procedure: augmentation peri-implant soft tissue
the implant was cover with a 2 mm cover screw for a tent effect or with a dermal membrane after implant insertion
group B
single edentulism implant insertion cover screw and membrane augmentation peri-implant soft tissue
Procedure: augmentation peri-implant soft tissue
the implant was cover with a 2 mm cover screw for a tent effect or with a dermal membrane after implant insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
soft tissue width
Time Frame: 6 months after surgery
measurement of the full thickness flap
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implant survival rate
Time Frame: two years from surgery
percentage of implant functional effective
two years from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Piezosurgery Academy

Investigators

  • Principal Investigator: Claudio Stacchi, Dr, Piezosurgery Academy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

October 31, 2019

Study Completion (Actual)

March 25, 2021

Study Registration Dates

First Submitted

November 25, 2017

First Submitted That Met QC Criteria

November 29, 2017

First Posted (Actual)

November 30, 2017

Study Record Updates

Last Update Posted (Actual)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 25, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DERMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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