Evaluation of Bone Quality and Primary and Secondary Stability of Implants Installed in Alveolar Regeneration Area by Three Different Techniques

May 31, 2019 updated by: Bruno Salles Sotto-Maior, Federal University of Juiz de Fora
The objective of this randomized controlled clinical study was to compare bone quality between three different alveolar ridge preservation methods, also with the evaluation of primary and secondary dental implant stabilities at these sites.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In the present study will be collected 24 patients, with indication of extraction of premolars or upper incisors. All participants will sign a Free and Informed Consent Form (TCLE), agreeing to participate voluntarily in this research.

Patients were randomly allocated into three groups according to the following treatments:

Group RET: Closure of the alveolus by first intention through palatal flap sliding according to the technique of Khoury.

SBC Group: Fill bone alveolus with Bone Ceramic® graft (Straumann AG, Basel, Switzerland) and cover it with palatal flap according to the technique of Khoury.

PRO Group: Alveolus sealing by a temporary ovoid pony of acrylic resin.

All patients will be prescribed the use of amoxicillin 2G, dexamethasone 4 mg and dipyrone sodium 500 mg one hour before the surgical procedure. After intra- and extraoral antisepsis with 0.12% and 2% chlorhexidine respectively, the sterile surgical fields were placed. Local anesthesia was obtained with lidocaine 2% epinephrine 1: 100,000.

With the aid of a surgical guide will be collected material for histological analysis, removed using trephine drill with 2.0 mm diameter. Samples will be removed before the incision, to be defined through the presence of gingival tissue the most coronal part of the sample. They will be placed immersed in a container with 10% formalin solution.

Then a linear incision will be made on the alveolar ridge in the region and detachment of the flap. The implants and components to be used are from Neodent® (Curitiba, PR, Brazil). The diameters used were standardized in 3.5 x 11.5 mm or 3.5 x 8 mm, depending on the remaining height of the collar. The milling and insertion system of the implants will follow the protocol recommended by the manufacturer. The drill rotation of the drills does not exceed 800 rpm, as recommended for Type III and IV bones.

The initial insertion of the implant will occur with the use of the contra-angle regulated at 30 rpm, the final insertion of the implant will be performed using a manual torque wrench, to measure the insertion torque and the registered value, preferably not exceeding 60 N.cm.The prosthetic component should be installed immediately after installation with an implant with a maximum torque of 20 N and on it adapted the SmartPeg® (Integration Diagnostics AB, Göteborg, Sweden). According to the manufacturer, the device generates a series of signals with different frequencies in Hertz (Hz) and these values are immediately converted to ISQ (Implantation Stability Coefficient), providing fast and accurate monitoring. The ISQ linear scale ranges from 1 to 100, with high ISQ values assuming high quality bone implant anchors. The calibration will be performed on the buccal and palatal surfaces of the intermediaries, that is, each implant submitted to 2 readings. The readings will be captured and recorded for further analysis.

Patients who do not achieve a minimum insertion torque of 30 N will have the micro-abutments removed, the implant cover screw installed, and sutured. In these patients, they will not have the values of SSI in the period of osseointegration of the implants. Implants that presented insertion torque equal to or greater than 30 N were to be maintained with the prosthetic components in position to have the repeated evaluations at intervals of 7 to 10 days, 30 days and 60 days, for evaluation of SSI in the period of osseointegration. With the objective of not subjecting the implant to torque and torque during this period and to avoid interfering with the osseointegration process, the micro-piers will be covered with the micro-pillar protection screws with digital pressure only, and the incision will be sutured.

Patients will receive guidance regarding postoperative care. It will be prescribed amoxicillin 500mg every eight hours for seven days, nimesulide 100mg twelve in twelve hours for three days, dipyrone sodium 500mg in case of pain and mouthwashes with chlorhexidine 0.12% of twelve in twelve hours until the removal of the sutures.After the surgical procedure, periapical radiographs of the operated region will be performed to check the position of the implants.

The microCT examination of each bone sample will be performed by the Skyscan® micrograph 1272 (Skyscan, Antwerp, Belgium) to analyze the bone microarchitecture of each location from which the implants were installed. After the analysis the samples will be subimeted to immunohistochemical tests.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • 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
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36036-300
        • Programa de Pós-graduação em Odontologia Faculdade de Odontologia - UFJF

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Extraction of premolars
  • Canines or incisors
  • Having two adjacent teet
  • Due to root fracture
  • Extensive cavities that do not allow restorative treatment and / or unfavorable -endodontic prognosis
  • Systemically healthy

Exclusion Criteria:

  • Patients who use any drug that influences bone metabolism
  • Patients with a history of head and neck radiotherapy
  • Patients undergoing chemotherapy for the treatment of malignant tumors at the time of the study
  • Patients with severely resorbed alveoli
  • Smokers
  • Pregnant

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: RET Group
Closure of the alveolus by first intention through palatal flap sliding according to the technique of Khoury et al. (2000).
Procedure: Immediate alveolar regeneration after exodontia
The extractions will be performed under local anesthesia, without making a mucoperiosteal flap, making an intraassucular incision and using appropriate periotomes, elevators and forcépes, minimizing the surgical trauma of surrounding tissues. Thorough curettage of the alveolus will be performed at the time of extraction to ensure removal of all granulation tissue and stimulate bleeding from the bone base, to form blood clot and promote healing. The sutures will be removed after 7 days of surgery, except for patients in group 3, in which sutures will not be made.
Other Names:
  • alveolar regeneration and implant insertion
Procedure: installation of dental implant and collection of biological material
The material was collected for histological analysis, extracted with trephine drill of 2.0 mm in diameter. Samples were removed before the incision. A linear incision was then made on the alveolar ridge in the region and flap detachment. The initial insertion of the implant was performed using the contra-angle at 30 rpm, the final insertion of the implant was performed with manual torque wrench, where the insertion torque was measured and the value was tabulated, not exceeding 60 N. cm. The component was installed with a maximum torque of 20 N and SmartPeg® (Integration Diagnostics AB, Göteborg, Sweden) was adapted. The prosthetic component was installed with a maximum torque of 20 N and SmartPeg® (Integration Diagnostics AB, Göteborg, Sweden) was adapted. the tabulated values and the incision was sutured.
Other Names:
  • installation of dental implant and collection of osseous and gingival tissue
Device: ISQ analysis
The prosthetic component already installed. On it is adapted the SmartPeg® (Integration Diagnostics AB, Göteborg, Sweden). According to the manufacturer, the device generates a series of signals with different frequencies in Hertz (Hz) and these values are immediately converted to ISQ (Implantation Stability Coefficient), providing fast and accurate monitoring. The calibration is performed on the buccal and palatal surfaces of the intermediaries, that is, each implant was submitted to 2 readings. The readings were captured and tabulated for further analysis. were repeated at intervals of 7 to 10 days, 30 days and 60 days, for evaluation of SSI in the period of osseointegration. With the objective of not subjecting the implant to torque and torque during this period and to avoid interfering with the osseointegration process, the micro-pillars were covered with the micro-pillar protection screws with digital pressure only.
Other Names:
  • ISQ measurement
Active Comparator: SBC Group
Fill bone alveolus with Bone Ceramic® graft (Straumann AG, Basel, Switzerland) and cover it with palatal flap according to the technique of Khoury et al. (2000).
Procedure: Immediate alveolar regeneration after exodontia
The extractions will be performed under local anesthesia, without making a mucoperiosteal flap, making an intraassucular incision and using appropriate periotomes, elevators and forcépes, minimizing the surgical trauma of surrounding tissues. Thorough curettage of the alveolus will be performed at the time of extraction to ensure removal of all granulation tissue and stimulate bleeding from the bone base, to form blood clot and promote healing. The sutures will be removed after 7 days of surgery, except for patients in group 3, in which sutures will not be made.
Other Names:
  • alveolar regeneration and implant insertion
Procedure: installation of dental implant and collection of biological material
The material was collected for histological analysis, extracted with trephine drill of 2.0 mm in diameter. Samples were removed before the incision. A linear incision was then made on the alveolar ridge in the region and flap detachment. The initial insertion of the implant was performed using the contra-angle at 30 rpm, the final insertion of the implant was performed with manual torque wrench, where the insertion torque was measured and the value was tabulated, not exceeding 60 N. cm. The component was installed with a maximum torque of 20 N and SmartPeg® (Integration Diagnostics AB, Göteborg, Sweden) was adapted. The prosthetic component was installed with a maximum torque of 20 N and SmartPeg® (Integration Diagnostics AB, Göteborg, Sweden) was adapted. the tabulated values and the incision was sutured.
Other Names:
  • installation of dental implant and collection of osseous and gingival tissue
Device: ISQ analysis
The prosthetic component already installed. On it is adapted the SmartPeg® (Integration Diagnostics AB, Göteborg, Sweden). According to the manufacturer, the device generates a series of signals with different frequencies in Hertz (Hz) and these values are immediately converted to ISQ (Implantation Stability Coefficient), providing fast and accurate monitoring. The calibration is performed on the buccal and palatal surfaces of the intermediaries, that is, each implant was submitted to 2 readings. The readings were captured and tabulated for further analysis. were repeated at intervals of 7 to 10 days, 30 days and 60 days, for evaluation of SSI in the period of osseointegration. With the objective of not subjecting the implant to torque and torque during this period and to avoid interfering with the osseointegration process, the micro-pillars were covered with the micro-pillar protection screws with digital pressure only.
Other Names:
  • ISQ measurement
Active Comparator: PRO Group
Alveolus sealing by a temporary ovoid pony of acrylic resin.
Procedure: Immediate alveolar regeneration after exodontia
The extractions will be performed under local anesthesia, without making a mucoperiosteal flap, making an intraassucular incision and using appropriate periotomes, elevators and forcépes, minimizing the surgical trauma of surrounding tissues. Thorough curettage of the alveolus will be performed at the time of extraction to ensure removal of all granulation tissue and stimulate bleeding from the bone base, to form blood clot and promote healing. The sutures will be removed after 7 days of surgery, except for patients in group 3, in which sutures will not be made.
Other Names:
  • alveolar regeneration and implant insertion
Procedure: installation of dental implant and collection of biological material
The material was collected for histological analysis, extracted with trephine drill of 2.0 mm in diameter. Samples were removed before the incision. A linear incision was then made on the alveolar ridge in the region and flap detachment. The initial insertion of the implant was performed using the contra-angle at 30 rpm, the final insertion of the implant was performed with manual torque wrench, where the insertion torque was measured and the value was tabulated, not exceeding 60 N. cm. The component was installed with a maximum torque of 20 N and SmartPeg® (Integration Diagnostics AB, Göteborg, Sweden) was adapted. The prosthetic component was installed with a maximum torque of 20 N and SmartPeg® (Integration Diagnostics AB, Göteborg, Sweden) was adapted. the tabulated values and the incision was sutured.
Other Names:
  • installation of dental implant and collection of osseous and gingival tissue
Device: ISQ analysis
The prosthetic component already installed. On it is adapted the SmartPeg® (Integration Diagnostics AB, Göteborg, Sweden). According to the manufacturer, the device generates a series of signals with different frequencies in Hertz (Hz) and these values are immediately converted to ISQ (Implantation Stability Coefficient), providing fast and accurate monitoring. The calibration is performed on the buccal and palatal surfaces of the intermediaries, that is, each implant was submitted to 2 readings. The readings were captured and tabulated for further analysis. were repeated at intervals of 7 to 10 days, 30 days and 60 days, for evaluation of SSI in the period of osseointegration. With the objective of not subjecting the implant to torque and torque during this period and to avoid interfering with the osseointegration process, the micro-pillars were covered with the micro-pillar protection screws with digital pressure only.
Other Names:
  • ISQ measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ISQ analysis
Time Frame: up to the conclusion of the study, an average of 2 years

result and closer Immediate / at the time of surgery (values from 0-100) where 0 is closest if zero is worse the to 100 the better.After 7 days (values from 0-100) where 0 is the closest to zero the result is worse and closer to 100 the better.

After 7 days (values from 0-100) where 0 is the closest to zero the result is worse and closer to 100 the better.

After 30 days (values from 0-100) where 0 is the closest to zero the result is worse and closer to 100 the better.

After 60 days (values from 0-100) where 0 is the closest to zero the result is worse and closer to 100 the better.
up to the conclusion of the study, an average of 2 years

Collaborators and Investigators

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

Sponsor

Federal University of Juiz de Fora

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2018

Primary Completion (Anticipated)

June 25, 2020

Study Completion (Anticipated)

August 30, 2020

Study Registration Dates

First Submitted

May 27, 2019

First Submitted That Met QC Criteria

May 31, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

May 31, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 51514715.9.0000.5147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

will be necessary the contact with the researcher

IPD Sharing Time Frame

to be defined

IPD Sharing Access Criteria

to be defined

IPD Sharing Supporting Information Type

  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

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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