NCT03106506

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
Last Updated

May 23, 2017

Status Verified

April 1, 2017

Enrollment Period

1.1 years

First QC Date

April 4, 2017

Last Update Submit

May 21, 2017

Conditions

Recession, Gingival

Keywords

ImplantsConjunctive tissue graftProspective study

Outcome Measures

Primary Outcomes (1)

  • Gain of peri-implant soft tissue

    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

Study Arms (2)

Test-implant with graft

EXPERIMENTAL

Patients who received a connective tissue graft around implants

Procedure: Connective tissue graft

Control-Implant without graft

ACTIVE COMPARATOR

Implant installation surgery with cone morse system without the placement of connective tissue graft.

Procedure: Connective tissue graft

Interventions

Connective tissue graftPROCEDURE

Implant installation surgery with cone morse system with the concomitant placement of autogenous connective tissue.

Control-Implant without graftTest-implant with graft

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

São Jose Dos Campos, São Paulo, 12245 000, Brazil

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Maria Jardini, Doctor

    Universidade Estadual Paulista Júlio de Mesquita Filho

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A sample of 40 individuals with esthetic need implants will be used for the study, where the test group (n = 20) will receive tec graft. (N = 20) will receive only the dental implant without the placement of a sub-epithelial-conjunctive tissue graft.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 10, 2017

Study Start

June 1, 2015

Primary Completion

July 1, 2016

Study Completion

March 1, 2017

Last Updated

May 23, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)