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Influence of Connective Tissue Graft Around Implants

Primary Purpose

Recession, Gingival

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Connective tissue graft
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Recession, Gingival focused on measuring Implants, Conjunctive tissue graft, Prospective study

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test-implant with graft

Control-Implant without graft

Arm Description

Patients who received a connective tissue graft around implants

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2017
Last Updated
May 21, 2017
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
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1. Study Identification

Unique Protocol Identification Number
NCT03106506
Brief Title
Influence of Connective Tissue Graft Around Implants
Official Title
Influence of Connective Tissue Graft Placement on the Volume of Soft Tissue Around Implants Placed in Aesthetic Areas. Randomized Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recession, Gingival
Keywords
Implants, Conjunctive tissue graft, Prospective study

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test-implant with graft
Arm Type
Experimental
Arm Description
Patients who received a connective tissue graft around implants
Arm Title
Control-Implant without graft
Arm Type
Active Comparator
Arm Description
Implant installation surgery with cone morse system without the placement of connective tissue graft.
Intervention Type
Procedure
Intervention Name(s)
Connective tissue graft
Intervention Description
Implant installation surgery with cone morse system with the concomitant placement of autogenous connective tissue.
Primary Outcome Measure Information:
Title
Gain of peri-implant soft tissue
Description
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.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Jardini, Doctor
Organizational Affiliation
Universidade Estadual Paulista Júlio de Mesquita Filho
Official's Role
Study Director
Facility Information:
City
São Jose dos Campos
State/Province
São Paulo
ZIP/Postal Code
12245 000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Influence of Connective Tissue Graft Around Implants

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