Alveolar Osseous LossNCT03973190
Evaluation of Bone Quality and Primary and Secondary Stability of Implants Installed in Alveolar Regeneration Area by Three Different Techniques
A study testing Immediate alveolar regeneration after exodontia, installation of dental implant and collection of biological material and ISQ analysis in people with Alveolar Osseous Loss, run by Federal University of Juiz de Fora at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Osseous Loss
- What is being tested?
- Immediate alveolar regeneration after exodontia, installation of dental implant and collection of biological material and ISQ analysis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2018to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Programa de Pós-graduação em Odontologia Faculdade de Odontologia - UFJF
Juiz de Fora, Minas Gerais, 36036-300
About this study
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.
Read the 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.
- Conditions
- Alveolar Osseous Loss
- Being tested
- Immediate alveolar regeneration after exodontia, installation of dental implant and collection of biological material, ISQ analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate alveolar regeneration after exodontiaProcedure or surgery
Also called alveolar regeneration and implant insertion
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.
installation of dental implant and collection of biological materialProcedure or surgery
Also called installation of dental implant and collection of osseous and gingival tissue
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.
ISQ analysisDevice
Also called ISQ measurement
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.
| Study group | Role | What they receive |
|---|---|---|
| RET Group | Placebo comparator | Closure of the alveolus by first intention through palatal flap sliding according to the technique of Khoury et al. (2000). Receives: 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). Receives: 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. Receives: Procedure: Immediate alveolar regeneration after exodontia; Procedure: installation of dental implant and collection of biological material; Device: ISQ analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to the conclusion of the study, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Aug 2018
- Primary completion25 Jun 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Alveolar Osseous LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Salles Sotto-Maior, Federal University of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973190
- Sponsor's protocol ID
- 51514715.9.0000.5147
- Status last verified
- May 2019
- First submitted
- 27 May 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: will be necessary the contact with the researcher
Publications
Acil Y, Sievers J, Gulses A, Ayna M, Wiltfang J, Terheyden H. Correlation between resonance frequency, insertion torque and bone-implant contact in self-cutting threaded implants. Odontology. 2017 Jul;105(3):347-353. doi: 10.1007/s10266-016-0265-2. Epub 2016 Aug 18.
PubMed 27538921Antunes AA, Grossi-Oliveira GA, Martins-Neto EC, Almeida AL, Salata LA. Treatment of circumferential defects with osseoconductive xenografts of different porosities: a histological, histometric, resonance frequency analysis, and micro-CT study in dogs. Clin Implant Dent Relat Res. 2015 Jan;17 Suppl 1:e202-20. doi: 10.1111/cid.12181. Epub 2013 Nov 28.
PubMed 24283568Araujo M, Linder E, Lindhe J. Effect of a xenograft on early bone formation in extraction sockets: an experimental study in dog. Clin Oral Implants Res. 2009 Jan;20(1):1-6. doi: 10.1111/j.1600-0501.2008.01606.x.
PubMed 19126101Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
PubMed 15691354Araujo MG, da Silva JCC, de Mendonca AF, Lindhe J. Ridge alterations following grafting of fresh extraction sockets in man. A randomized clinical trial. Clin Oral Implants Res. 2015 Apr;26(4):407-412. doi: 10.1111/clr.12366. Epub 2014 Mar 12.
PubMed 24621203Artzi Z, Tal H, Dayan D. Porous bovine bone mineral in healing of human extraction sockets. Part 1: histomorphometric evaluations at 9 months. J Periodontol. 2000 Jun;71(6):1015-23. doi: 10.1902/jop.2000.71.6.1015.
PubMed 10914806Barone A, Borgia V, Covani U, Ricci M, Piattelli A, Iezzi G. Flap versus flapless procedure for ridge preservation in alveolar extraction sockets: a histological evaluation in a randomized clinical trial. Clin Oral Implants Res. 2015 Jul;26(7):806-13. doi: 10.1111/clr.12358. Epub 2014 Mar 1.
PubMed 24580835Bataineh AB, Al-Dakes AM. The influence of length of implant on primary stability: An in vitro study using resonance frequency analysis. J Clin Exp Dent. 2017 Jan 1;9(1):e1-e6. doi: 10.4317/jced.53302. eCollection 2017 Jan.
PubMed 28149455Baumer D, Zuhr O, Rebele S, Hurzeler M. Socket Shield Technique for immediate implant placement - clinical, radiographic and volumetric data after 5 years. Clin Oral Implants Res. 2017 Nov;28(11):1450-1458. doi: 10.1111/clr.13012. Epub 2017 Mar 23.
PubMed 28333394Becker W, Sennerby L, Bedrossian E, Becker BE, Lucchini JP. Implant stability measurements for implants placed at the time of extraction: a cohort, prospective clinical trial. J Periodontol. 2005 Mar;76(3):391-7. doi: 10.1902/jop.2005.76.3.391.
PubMed 15857073Bornstein MM, Hart CN, Halbritter SA, Morton D, Buser D. Early loading of nonsubmerged titanium implants with a chemically modified sand-blasted and acid-etched surface: 6-month results of a prospective case series study in the posterior mandible focusing on peri-implant crestal bone changes and implant stability quotient (ISQ) values. Clin Implant Dent Relat Res. 2009 Dec;11(4):338-47. doi: 10.1111/j.1708-8208.2009.00148.x. Epub 2009 Apr 23.
PubMed 19438966Bornstein MM, Valderrama P, Jones AA, Wilson TG, Seibl R, Cochran DL. Bone apposition around two different sandblasted and acid-etched titanium implant surfaces: a histomorphometric study in canine mandibles. Clin Oral Implants Res. 2008 Mar;19(3):233-41. doi: 10.1111/j.1600-0501.2007.01473.x. Epub 2008 Jan 3.
PubMed 18177427Bouwman WF, Bravenboer N, Frenken JWFH, Ten Bruggenkate CM, Schulten EAJM. The use of a biphasic calcium phosphate in a maxillary sinus floor elevation procedure: a clinical, radiological, histological, and histomorphometric evaluation with 9- and 12-month healing times. Int J Implant Dent. 2017 Dec;3(1):34. doi: 10.1186/s40729-017-0099-x. Epub 2017 Jul 25.
PubMed 28741276Buser D, Broggini N, Wieland M, Schenk RK, Denzer AJ, Cochran DL, Hoffmann B, Lussi A, Steinemann SG. Enhanced bone apposition to a chemically modified SLA titanium surface. J Dent Res. 2004 Jul;83(7):529-33. doi: 10.1177/154405910408300704.
PubMed 15218041Santamaria-Arrieta G, Brizuela-Velasco A, Fernandez-Gonzalez FJ, Chavarri-Prado D, Chento-Valiente Y, Solaberrieta E, Dieguez-Pereira M, Vega JA, Yurrebaso-Asua J. Biomechanical evaluation of oversized drilling technique on primary implant stability measured by insertion torque and resonance frequency analysis. J Clin Exp Dent. 2016 Jul 1;8(3):e307-11. doi: 10.4317/jced.52873. eCollection 2016 Jul.
PubMed 27398182
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Quality and Primary and Secondary Stability of Implants Installed in Alveolar Regeneration Area by Three Different Techniques
- ClinicalTrials.gov ID
- NCT03973190
- Acronym / sponsor ID
- 51514715.9.0000.5147
- Conditions
- Alveolar Osseous Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 25 Jun 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| RET Group | Placebo comparator | Procedure: Immediate alveolar regeneration after exodontia, Procedure: installation of dental implant and collection of biological material, Device: ISQ analysisClosure of the alveolus by first intention through palatal flap sliding according to the technique of Khoury et al. (2000). |
| SBC Group | Active comparator | Procedure: Immediate alveolar regeneration after exodontia, Procedure: installation of dental implant and collection of biological material, Device: ISQ analysisFill 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 | Active comparator | Procedure: Immediate alveolar regeneration after exodontia, Procedure: installation of dental implant and collection of biological material, Device: ISQ analysisAlveolus sealing by a temporary ovoid pony of acrylic resin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate alveolar regeneration after exodontiaAlso: alveolar regeneration and implant insertionThe 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. | Procedure or surgery | PRO Group, RET Group, SBC Group |
| installation of dental implant and collection of biological materialAlso: installation of dental implant and collection of osseous and gingival tissueThe 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. | Procedure or surgery | PRO Group, RET Group, SBC Group |
| ISQ analysisAlso: ISQ measurementThe 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. | Device | PRO Group, RET Group, SBC Group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Background: PubMed 27538921Acil Y, Sievers J, Gulses A, Ayna M, Wiltfang J, Terheyden H. Correlation between resonance frequency, insertion torque and bone-implant contact in self-cutting threaded implants. Odontology. 2017 Jul;105(3):347-353. doi: 10.1007/s10266-016-0265-2. Epub 2016 Aug 18.
- Background: PubMed 24283568Antunes AA, Grossi-Oliveira GA, Martins-Neto EC, Almeida AL, Salata LA. Treatment of circumferential defects with osseoconductive xenografts of different porosities: a histological, histometric, resonance frequency analysis, and micro-CT study in dogs. Clin Implant Dent Relat Res. 2015 Jan;17 Suppl 1:e202-20. doi: 10.1111/cid.12181. Epub 2013 Nov 28.
- Background: PubMed 19126101Araujo M, Linder E, Lindhe J. Effect of a xenograft on early bone formation in extraction sockets: an experimental study in dog. Clin Oral Implants Res. 2009 Jan;20(1):1-6. doi: 10.1111/j.1600-0501.2008.01606.x.
- Background: PubMed 15691354Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
- Background: PubMed 24621203Araujo MG, da Silva JCC, de Mendonca AF, Lindhe J. Ridge alterations following grafting of fresh extraction sockets in man. A randomized clinical trial. Clin Oral Implants Res. 2015 Apr;26(4):407-412. doi: 10.1111/clr.12366. Epub 2014 Mar 12.
- Background: PubMed 10914806Artzi Z, Tal H, Dayan D. Porous bovine bone mineral in healing of human extraction sockets. Part 1: histomorphometric evaluations at 9 months. J Periodontol. 2000 Jun;71(6):1015-23. doi: 10.1902/jop.2000.71.6.1015.
- Background: PubMed 24580835Barone A, Borgia V, Covani U, Ricci M, Piattelli A, Iezzi G. Flap versus flapless procedure for ridge preservation in alveolar extraction sockets: a histological evaluation in a randomized clinical trial. Clin Oral Implants Res. 2015 Jul;26(7):806-13. doi: 10.1111/clr.12358. Epub 2014 Mar 1.
- Background: PubMed 28149455Bataineh AB, Al-Dakes AM. The influence of length of implant on primary stability: An in vitro study using resonance frequency analysis. J Clin Exp Dent. 2017 Jan 1;9(1):e1-e6. doi: 10.4317/jced.53302. eCollection 2017 Jan.
- Background: PubMed 28333394Baumer D, Zuhr O, Rebele S, Hurzeler M. Socket Shield Technique for immediate implant placement - clinical, radiographic and volumetric data after 5 years. Clin Oral Implants Res. 2017 Nov;28(11):1450-1458. doi: 10.1111/clr.13012. Epub 2017 Mar 23.
- Background: PubMed 15857073Becker W, Sennerby L, Bedrossian E, Becker BE, Lucchini JP. Implant stability measurements for implants placed at the time of extraction: a cohort, prospective clinical trial. J Periodontol. 2005 Mar;76(3):391-7. doi: 10.1902/jop.2005.76.3.391.
- Background: PubMed 19438966Bornstein MM, Hart CN, Halbritter SA, Morton D, Buser D. Early loading of nonsubmerged titanium implants with a chemically modified sand-blasted and acid-etched surface: 6-month results of a prospective case series study in the posterior mandible focusing on peri-implant crestal bone changes and implant stability quotient (ISQ) values. Clin Implant Dent Relat Res. 2009 Dec;11(4):338-47. doi: 10.1111/j.1708-8208.2009.00148.x. Epub 2009 Apr 23.
- Background: PubMed 18177427Bornstein MM, Valderrama P, Jones AA, Wilson TG, Seibl R, Cochran DL. Bone apposition around two different sandblasted and acid-etched titanium implant surfaces: a histomorphometric study in canine mandibles. Clin Oral Implants Res. 2008 Mar;19(3):233-41. doi: 10.1111/j.1600-0501.2007.01473.x. Epub 2008 Jan 3.
- Individual participant dataSharing planned: Yes. will be necessary the contact with the researcher
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate alveolar regeneration after exodontia, installation of dental implant and collection of biological material and ISQ analysis in people with Alveolar Osseous Loss, run by Federal University of Juiz de Fora at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ISQ analysis (time frame: up to the conclusion of the study, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03973190, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.