Influence of Connective Tissue Graft Around Implants

NCT ID: NCT03106506

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-03-31

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).

Conditions

Recession, Gingival

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Test-implant with graft

Patients who received a connective tissue graft around implants

Group Type: EXPERIMENTAL

Connective tissue graft

Intervention Type: PROCEDURE

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

Control-Implant without graft

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

Group Type: ACTIVE_COMPARATOR

Connective tissue graft

Intervention Type: PROCEDURE

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

Interventions

Connective tissue graft

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role: lead

Responsible Party

Maria Aparecida Neves Jardini

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Jardini, Doctor

Role: STUDY_DIRECTOR

Universidade Estadual Paulista Júlio de Mesquita Filho

Locations

São Jose Dos Campos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

f4vqwv6j

Identifier Type: -

Identifier Source: org_study_id