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

NCT03973190 | Unknown DMC

• 1 other identifier: 51514715.9.0000.5147
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alveolar Osseous Loss

Outcome Measures

Primary Outcomes (1)

• ISQ analysis

  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

Study Arms (3)

RET Group

PLACEBO COMPARATOR

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; Procedure: installation of dental implant and collection of biological material; Device: ISQ analysis

SBC Group

ACTIVE COMPARATOR

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; Procedure: installation of dental implant and collection of biological material; Device: ISQ analysis

PRO Group

ACTIVE COMPARATOR

Alveolus sealing by a temporary ovoid pony of acrylic resin.

Procedure: Immediate alveolar regeneration after exodontia; Procedure: installation of dental implant and collection of biological material; Device: ISQ analysis

Interventions

Immediate alveolar regeneration after exodontia PROCEDURE

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.

Also known as: alveolar regeneration and implant insertion

PRO Group; RET Group; SBC Group

installation of dental implant and collection of biological material PROCEDURE

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.

Also known as: installation of dental implant and collection of osseous and gingival tissue

PRO Group; RET Group; SBC Group

ISQ analysis DEVICE

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.

Also known as: ISQ measurement

PRO Group; RET Group; SBC Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Juiz de Fora: lead

Study Sites (1)

Programa de Pós-graduação em Odontologia Faculdade de Odontologia - UFJF

Juiz de Fora, Minas Gerais, 36036-300, Brazil

Location

Related Publications (20)

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Group RET: Closure of the alveolus by first intention through palatal flap sliding according to the technique of Khoury et al. (2000). 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). PRO Group: Alveolus sealing by a temporary ovoid pony of acrylic resin

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 4, 2019
• Study Start: August 1, 2018
• Primary Completion: June 25, 2020
• Study Completion: August 30, 2020
• Last Updated: June 4, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: to be defined
• Access Criteria: to be defined

Locations

BR (1)