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Influence of Connective Tissue Graft Around Implants

U

Universidade Estadual Paulista Júlio de Mesquita Filho

Status

Completed

Conditions

Recession, Gingival

Treatments

Procedure: Connective tissue graft

Study type

Interventional

Funder types

Other

Identifiers

NCT03106506
f4vqwv6j

Details and patient eligibility

About

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.

Full 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).

Enrollment

40 patients

Sex

All

Ages

20+ years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

Test-implant with graft
Experimental group
Description:
Patients who received a connective tissue graft around implants
Treatment:
Procedure: Connective tissue graft
Control-Implant without graft
Active Comparator group
Description:
Implant installation surgery with cone morse system without the placement of connective tissue graft.
Treatment:
Procedure: Connective tissue graft

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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