Influence of Connective Tissue Graft Around Implants

May 21, 2017 updated by: Maria Aparecida Neves Jardini, Universidade Estadual Paulista Júlio de Mesquita Filho

Influence of Connective Tissue Graft Placement on the Volume of Soft Tissue Around Implants Placed in Aesthetic Areas. Randomized Controlled Clinical Trial.

The objective of this randomized controlled clinical study was to evaluate the increase in the volume of peri-implant gingival tissue in implants installed in the aesthetic areas with the use of subepithelial-conjunctive tissue graft, and a sample of 40 individuals with implants Aesthetics where the test group (n = 20) will receive tec graft. (N = 20) will receive only the dental implant without the placement of a tec graft. Epithelial-conjunctival.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Osseointegrated implants have been used since the mid-1950s, and countless studies have ensured the reliability of their use, so the implant has become a common practice among dental surgeons, as the use of implants has increased its complications as well. Accompany the same development, especially when they are installed in aesthetic areas, where deficiency of periimplant gingival tissue is insufficient.

The objective of this randomized controlled clinical study was to evaluate the increase in the volume of periimplant gingival tissue in implants installed in the aesthetic areas with the use of subepithelial conjunctive tissue graft, and a sample of 40 individuals with implants aesthetics where the test group (n = 20) will receive tec graft. (N = 20) will receive only the dental implant without the placement of a tec graft epithelial conjunctival.

In order to analyze the increase of gingival periimplant tissue, pre, trans and postoperative clinical measurements, aesthetic evaluation, patient satisfaction assessment and improvement of the quality of life will be performed and the radiographic measurements will be performed to evaluate the periimplant bone structures and their influence on the results.

These measurements will be performed in the pre-operative (baseline), 6 months postoperatively and 6 months after installation of the definitive crown on the implant, the study will have a power of 80% (p = 0.05).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Brazil
    • São Paulo
      • São Jose dos Campos, São Paulo, Brazil, 12245 000

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients at least 20 years of age systemically healthy , oral hygiene satisfactory,assessed by plaque index Gingival Index and less than 25% (O'Leary et al. 1972).
  • Patient requiring one implant in the anterior maxilla (premolar of the premolar).
  • Availability of healthy bone tissue or greater than five millimeters, with the view to greater primary stability or equal to 35 Ncm
  • agreed to participate in the study and sign a written consent ( Resolution No. 196 of October 1996 and the Code of Professional Ethics Dental - C.F.O. - 179/93)

Exclusion Criteria:

  • Smokers;
  • Patients with parafunctional habits such as bruxism;
  • Pregnant or lactating;
  • Patients with systemic diseases uncontrolled (cardiovascular diseases, blood disorders, changes in bone metabolism, immunodeficiencies and diabetes) , contraindicate the surgical procedure.
  • Drugs that interfere with wound healing, Drug Related gingival hyperplasia phenytoin (dantalin, dialudon, Epelin, fenital, phenytoin, phenytoin sodium, hidantal), cyclosporine A (Restasis, Sandimmun Neoral Sandimmunmicroral Sigmasporin), blockers of calcium channel, (bezilato of amilodipina hydrochloride, ditiaziem, felodipine, isradipine, lacidipine, lercadinipina hydrochloride, micardipina hydrochloride, nifedipine, risoldipina) Immunosuppressive drugs such as Azathioprine, and Prednisolone, drugs of the class of bisphosphonates(alendronate, zoledronate, ibandronate, risedronate, pamidronate, clodronate, etidronate and clodronate) that reduce the metabolism of osteoclasts , inhibiting bone metabolism;
  • Implants in adjacent regions;
  • Sites of acute infections;
  • Sites with large defects in the buccal bone wall;
  • Requiring any sort of bone augmentation procedure;
  • Patients in orthodontic treatment.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test-implant with graft
Patients who received a connective tissue graft around implants
Procedure: Connective tissue graft
Implant installation surgery with cone morse system with the concomitant placement of autogenous connective tissue.
Active Comparator: Control-Implant without graft
Implant installation surgery with cone morse system without the placement of connective tissue graft.
Procedure: Connective tissue graft
Implant installation surgery with cone morse system with the concomitant placement of autogenous connective tissue.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gain of peri-implant soft tissue
Time Frame: one year
It is expected that the association of autogenous connective graft to the placement of cone-morse platform implants in aesthetic areas allows a greater gain of peri-implant soft tissue and better aesthetic results after the installation of definitive prostheses than in the other proposed groups.
one year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Estadual Paulista Júlio de Mesquita Filho

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Maria Jardini, Doctor, Universidade Estadual Paulista Julio de Mesquita Filho

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • f4vqwv6j

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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